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Senior Vice President jobs at Alnylam Pharmaceuticals

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  • Director, Global Regulatory Leader

    Johnson & Johnson 4.7company rating

    New Jersey jobs

    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: Regulatory Affairs Group Job Sub Function: Regulatory Affairs Job Category: Professional All Job Posting Locations: Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America Job Description: About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at *******************/innovative-medicine Johnson & Johnson Innovative Medicine R&D is recruiting for a Director, Global Regulatory Leader. This position is a hybrid role and can be located in Spring House, PA; Titusville, NJ; or Raritan, NJ. Remote work options may be considered on a case-by-case basis and if approved by the Company and will be available in all states within the United States. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply. The Director, Global Regulatory Leader in Global Regulatory Affairs will be responsible for the development, implementation, and maintenance of global regulatory strategies for investigational rare disease and advanced cell therapy products supporting programs in the Immunology Therapeutic Area. Principal Responsibilities: * As the global regulatory lead for assigned projects, develop and implement integrated regulatory strategies and operational plans for investigational rare disease and advanced cell therapy products within the Immunology Therapeutic Area. Ensure strategies are aligned with portfolio objectives, regional regulatory requirements, CMC considerations, commercial goals, and market access plans. * Serve as the key regulatory point of contact, providing leadership and guidance across cross-functional teams to support successful development and commercialization, including providing input on implications of regulatory strategy through participation in product-related teams. * Lead the project Global Regulatory Team (GRT) and participate in the Compound Development Team (CDT) as needed. * Lead and/or participate in meetings with regulatory agencies as appropriate and prepare company personnel for interactions with Health Authorities (HAs). Ensure that responses to FDA questions are handled in a timely manner and in line with the approved product strategy. * Lead and oversee key health authority documents (e.g., IND/CTA, meeting requests, briefing packages, responses, marketing applications) according to the strategic plan for the region and health authority commitments. Perform critical review of submission documents to ensure compliance with regulatory requirements. * Negotiate and manage regional post-approval commitments and global label expansion strategies. * Maintain an understanding of the competitive landscape (e.g., views of HAs, regulatory precedents, labeling differences and disease area-specific issues) and provide proactive strategic regulatory advice to project teams and global regulatory teams. * Maintain working knowledge of laws, guidances and requirements related to autoimmune diseases, in addition to general regulatory knowledge and provide strategic regulatory input into clinical trial designs, labeling, risk management, and development programs to meet global and regional requirements. * Support due diligence and business development assessments. * Identify and resolve regulatory issues that may affect projects or organizational objectives. Qualifications: * A minimum of a Bachelor's degree is required, preferably in a scientific or technical discipline. Advanced degree (Master's, PharmD or PhD) is preferred. * A minimum of 10 years of global health regulated industry is required. * Global regulatory experience with deep expertise in U.S. FDA, EMA, and international regulations within scientific and commercial contexts is required. * Knowledge of the drug product lifecycle from discovery to clinical trials to marketing is required. * An understanding of FDA and International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) regulatory requirements and guidelines specific to the areas of clinical research, product development, and labeling is required. * An understanding of the regulatory submission and approval process is required. * Experience critically reviewing and compiling regulatory documents is required. * Knowledge of the Immunology and Oncology therapeutic areas is strongly preferred. * Knowledge of advanced therapies, such as CAR-T, is strongly preferred. * Demonstrated ability to interpret and apply regulatory requirements and precedents is required. * A proven track record in shaping global regulatory strategies, ensuring compliance, and leading direct interactions with Health Authorities is required. * Must have excellent oral and written communication skills. * Must have strong organization and multi-tasking skills. * A proven track record of working successfully within a collaborative team environment and building positive relationships as an individual contributor is preferred. * The ability to effectively prioritize assignments for multiple products and projects simultaneously is preferred. * The ability to exercise independent judgment and execution in anticipating, evaluating and resolving complex functional and/or complex organizational issues with novel and practical solutions is required. * This position may require up to 10% domestic and international travel. The anticipated base pay range for this position in the San Francisco Bay Area, CA is $189,000 to $325,450. The anticipated base pay range for this position in U.S. locations is $164,000 to $282,900. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/ performance year. Bonuses are awarded at the Company's discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). Employees are eligible for the following time off benefits: * Vacation - up to 120 hours per calendar year * Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year * Holiday pay, including Floating Holidays - up to 13 days per calendar year * Work, Personal and Family Time - up to 40 hours per calendar year For additional general information on company benefits, please go to: ********************************************* The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. This job posting is anticipated to close on December 16, 2025. The Company may however extend this time-period, in which case the posting will remain available on *************************** to accept additional applications. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource. #LI-Hybrid Required Skills: Preferred Skills: Analytical Reasoning, Business Writing, Fact-Based Decision Making, Industry Analysis, Legal Support, Mentorship, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments, Risk Compliance, Strategic Thinking, Tactical Planning, Technical Credibility The anticipated base pay range for this position is : The anticipated base pay range for this position in the San Francisco Bay Area, CA is $189,000 to $325,450. The anticipated base pay range for this position in U.S. locations is $164,000 to $282,900. Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation -120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year Holiday pay, including Floating Holidays -13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave - 10 days Volunteer Leave - 4 days Military Spouse Time-Off - 80 hours Additional information can be found through the link below. *********************************************
    $189k-325.5k yearly Auto-Apply 12d ago
  • Senior Director, Cell Therapy Discovery (Cell & Genetic Medicines)

    Johnson & Johnson 4.7company rating

    Cambridge, MA jobs

    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: Discovery & Pre-Clinical/Clinical Development Job Sub Function: Biotherapeutics R&D Job Category: People Leader All Job Posting Locations: Cambridge, Massachusetts, United States of America, Remote (US), Spring House, Pennsylvania, United States of America Job Description: About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at *******************/innovative-medicine We are searching for the best talent for the best Senior Director, Cell Therapy Discovery (Cell & Genetic Medicines) to be in Spring House, PA or Cambridge, MA. Remote work options may be considered on a case-by-case basis and if approved by the Company. Purpose: We are seeking a Senior Director of Cell Therapy Discovery to lead and accelerate innovative research efforts in the field of CAR T cell therapies. This leadership role is pivotal in shaping the future of our pipeline and advancing cutting-edge treatments. The ideal candidate will possess extensive expertise in cellular immunology and therapeutic development, with a proven track record of leading discovery teams and delivering impactful results. You will be responsible for: * Strategic Leadership: Drive the overall strategy and scientific direction of the cell therapy discovery pipeline, aligning with corporate strategy and industry trends. * Team Management: Mentor discovery project leaders, and foster a culture of scientific excellence, innovation, and continuous learning. Drive talent development to build capabilities in cutting-edge cell therapy technologies. * Scientific Innovation: Identify and execute novel approaches for cell therapy research, including gene editing, innovative transgene design, and delivery strategies. * External Partnerships: Establish and manage strategic collaborations with academic institutions, biotech partners, and external CROs to supplement internal expertise, access novel technologies, and accelerate discovery efforts. * Pipeline Advancement: Oversee the progression of early-stage discovery programs from ideation through validation, ensuring pipeline robustness and innovation. * Regulatory & Compliance: Ensure all research activities adhere to regulatory standards, ethical guidelines, and safety protocols. * Budget & Resource Planning: Oversee departmental budgets, resource allocation, and project prioritization to maximize research productivity. Qualifications: * PhD or equivalent experience in Cell Biology, Immunology, Bioengineering, or related field. * 12+ years of overall experience in biotech, pharmaceutical, or related academia environments is required; ideally leadership experience in cell therapy discovery is preferred. * Proven track record of innovative scientific contributions, including advancing discovery programs through R&D milestones. * Demonstrated experience leading and developing multidisciplinary teams. * Strong understanding of development considerations in early-stage programs. * Excellent communication, strategic thinking, and collaboration skills. * This role may require 10-20% travel. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (********************************) or contact AskGS to be directed to your accommodation resource. Required Skills: Preferred Skills: Cell and Gene Therapy, Drug Discovery Development, Drug Discovery Research, Scientific Innovation The anticipated base pay range for this position is : $193,000 to $333,500 Additional Description for Pay Transparency: Additional Description for Pay Transparency The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. • Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). • Employees are eligible for the following time off benefits: o Vacation - up to 120 hours per calendar year o Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year o Holiday pay, including Floating Holidays - up to 13 days per calendar year o Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. ********************************************* The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
    $193k-333.5k yearly Auto-Apply 30d ago
  • Director, Strategic Planning

    Merck 4.6company rating

    Rahway, NJ jobs

    The Enterprise Strategy Office (ESO) develops, implements, and drives enterprise strategy in support of our company, its customers, and other stakeholders. The scope of this group includes strategy development, strategy execution and value realization, enterprise strategic planning, risk management, and strategic venture investments in healthcare as part of our Global Health Innovation fund. Together, we identify business critical opportunities, frame and evaluate options, and ensure effective implementation and cross-functional engagement to realize impact. Oncology is a key area of focus for our company, and our portfolio is large, diverse and evolving rapidly. Within ESO, we provide deep strategic partnership in developing, assessing and shaping our strategy at the portfolio, indication and asset level, as well as the capabilities we need to continue delivering transformative therapies to patients. **Position Description:** The person in this role will help develop and drive Oncology R&D strategy priorities, tackling complex and often ambiguous questions that have significant upside for our Company. They will work with senior leaders to identify and frame important topics, conduct rigorous assessments that can inform leadership decision-making; develop, refine and lead Oncology strategic initiatives across our Company; and help evolve and establish capabilities needed for our Company's Oncology Research & Development to be successful. This individual will collaborate cross-functionally with Oncology leaders across our Company and will be a critical partner across multiple teams. They will be charged with solving problems, driving value, and building a coalition of support that is needed for the creation and adoption of change. This individual will foster a psychologically safe, diverse, and inclusive environment by leading teams both directly and indirectly and mentoring special assignment partners. **Primary Responsibilities:** + Partner with Oncology senior management and leaders to identify high-value strategic imperatives + Lead the framing, assessment, and recommendation of key initiatives in collaboration with executive leaders across oncology + Develop fact-bases using internal and external data sets to support leadership decision making + Interrogate a deep and broad Research & Development portfolio to aid in resource allocation, prioritization and maximization of patient impact + Bring to bear experience in oncology (across discovery, translational sciences, development and commercialization) to identify capability gaps and ways to evolve + Lead internal and external teams to drive ideas from conception to implementation + Partner with cross-functional teams to support implementation and deliver on key objectives + Drive cultural engagement with diverse and inclusive teams **Position Qualifications** **:** **Education and Industry Experience Requirement:** + PhD in a relevant scientific discipline (Oncology preferred) or MD from a top ranked program, equivalent experience considered + 4+ years of strategy management consulting experience from a top-tier firm (e.g., BCG, McKinsey, Bain) or equivalent strategy experience driving R&D programs + Minimum of 5+ years of biopharma-related experience post PhD/MD in a relevant strategy consulting or industry context, with deep expertise in Oncology R&D + Experience managing teams as well as external vendors **Required Skills:** + Advanced degree (or equivalent experience) with demonstrated capability across diverse roles and functions + Problem solving and insight generation - ability to frame and conceptualize complex, ambiguous questions and drive towards clear, substantiated answers relevant to the questions at hand + Strong analytical skills with ability to efficiently interrogate different types of data to deliver relevant, high-quality insights + Strong communicator with excellent verbal and written skills; ability to communicate effectively with senior management and across all levels of the business + Demonstrated leadership qualities with the ability to empathize, listen, and enable other colleagues to thrive + Ability to influence decision-making in a highly matrixed organization + Strong business acumen, with ability to build consensus + Demonstrated ability to prioritize and solve problems, focusing on the highest-impact initiatives + High emotional intelligence; growth mindset with strong curiosity and intrinsic motivation + Collaborative team player who is organized, coachable, and driven to improve **Location** : Rahway, NJ preferred with the potential opportunity for placement in Boston **Required Skills:** Business Strategy Consulting, Collaborating, Communication, Data-Driven Decision Making, Influencing Skills, Leadership, Management Consulting, Oncology, Prioritization, Risk Management, Strategic Thinking, Strategy Development, Strategy Execution, Teamwork Orientation **Preferred Skills:** Current Employees apply HERE (***************************************************** Current Contingent Workers apply HERE (***************************************************** **US and Puerto Rico Residents Only:** Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (*************************************** if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights (****************************************************************************************** EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts (********************************************** **U.S. Hybrid Work Model** Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote". The salary range for this role is $169,700.00 - $267,200.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ****************************************************** . You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. **San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance **Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance **Search Firm Representatives Please Read Carefully** Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. **Employee Status:** Regular **Relocation:** No relocation **VISA Sponsorship:** No **Travel Requirements:** 10% **Flexible Work Arrangements:** Hybrid **Shift:** Not Indicated **Valid Driving License:** No **Hazardous Material(s):** NA **Job Posting End Date:** 12/15/2025 ***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.** **Requisition ID:** R372942
    $169.7k-267.2k yearly 33d ago
  • Director, Global Regulatory Leader

    Johnson & Johnson 4.7company rating

    Raritan, NJ jobs

    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: Regulatory Affairs Group Job Sub Function: Regulatory Affairs Job Category: Professional All Job Posting Locations: Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America Job Description: About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at *******************/innovative-medicine Johnson & Johnson Innovative Medicine R&D is recruiting for a Director, Global Regulatory Leader. This position is a hybrid role and can be located in Spring House, PA; Titusville, NJ; or Raritan, NJ. Remote work options may be considered on a case-by-case basis and if approved by the Company and will be available in all states within the United States. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply. The Director, Global Regulatory Leader in Global Regulatory Affairs will be responsible for the development, implementation, and maintenance of global regulatory strategies for investigational rare disease and advanced cell therapy products supporting programs in the Immunology Therapeutic Area. Principal Responsibilities: * As the global regulatory lead for assigned projects, develop and implement integrated regulatory strategies and operational plans for investigational rare disease and advanced cell therapy products within the Immunology Therapeutic Area. Ensure strategies are aligned with portfolio objectives, regional regulatory requirements, CMC considerations, commercial goals, and market access plans. * Serve as the key regulatory point of contact, providing leadership and guidance across cross-functional teams to support successful development and commercialization, including providing input on implications of regulatory strategy through participation in product-related teams. * Lead the project Global Regulatory Team (GRT) and participate in the Compound Development Team (CDT) as needed. * Lead and/or participate in meetings with regulatory agencies as appropriate and prepare company personnel for interactions with Health Authorities (HAs). Ensure that responses to FDA questions are handled in a timely manner and in line with the approved product strategy. * Lead and oversee key health authority documents (e.g., IND/CTA, meeting requests, briefing packages, responses, marketing applications) according to the strategic plan for the region and health authority commitments. Perform critical review of submission documents to ensure compliance with regulatory requirements. * Negotiate and manage regional post-approval commitments and global label expansion strategies. * Maintain an understanding of the competitive landscape (e.g., views of HAs, regulatory precedents, labeling differences and disease area-specific issues) and provide proactive strategic regulatory advice to project teams and global regulatory teams. * Maintain working knowledge of laws, guidances and requirements related to autoimmune diseases, in addition to general regulatory knowledge and provide strategic regulatory input into clinical trial designs, labeling, risk management, and development programs to meet global and regional requirements. * Support due diligence and business development assessments. * Identify and resolve regulatory issues that may affect projects or organizational objectives. Qualifications: * A minimum of a Bachelor's degree is required, preferably in a scientific or technical discipline. Advanced degree (Master's, PharmD or PhD) is preferred. * A minimum of 10 years of global health regulated industry is required. * Global regulatory experience with deep expertise in U.S. FDA, EMA, and international regulations within scientific and commercial contexts is required. * Knowledge of the drug product lifecycle from discovery to clinical trials to marketing is required. * An understanding of FDA and International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) regulatory requirements and guidelines specific to the areas of clinical research, product development, and labeling is required. * An understanding of the regulatory submission and approval process is required. * Experience critically reviewing and compiling regulatory documents is required. * Knowledge of the Immunology and Oncology therapeutic areas is strongly preferred. * Knowledge of advanced therapies, such as CAR-T, is strongly preferred. * Demonstrated ability to interpret and apply regulatory requirements and precedents is required. * A proven track record in shaping global regulatory strategies, ensuring compliance, and leading direct interactions with Health Authorities is required. * Must have excellent oral and written communication skills. * Must have strong organization and multi-tasking skills. * A proven track record of working successfully within a collaborative team environment and building positive relationships as an individual contributor is preferred. * The ability to effectively prioritize assignments for multiple products and projects simultaneously is preferred. * The ability to exercise independent judgment and execution in anticipating, evaluating and resolving complex functional and/or complex organizational issues with novel and practical solutions is required. * This position may require up to 10% domestic and international travel. The anticipated base pay range for this position in the San Francisco Bay Area, CA is $189,000 to $325,450. The anticipated base pay range for this position in U.S. locations is $164,000 to $282,900. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/ performance year. Bonuses are awarded at the Company's discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). Employees are eligible for the following time off benefits: * Vacation - up to 120 hours per calendar year * Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year * Holiday pay, including Floating Holidays - up to 13 days per calendar year * Work, Personal and Family Time - up to 40 hours per calendar year For additional general information on company benefits, please go to: ********************************************* The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. This job posting is anticipated to close on December 16, 2025. The Company may however extend this time-period, in which case the posting will remain available on *************************** to accept additional applications. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource. #LI-Hybrid Required Skills: Preferred Skills: Analytical Reasoning, Business Writing, Fact-Based Decision Making, Industry Analysis, Legal Support, Mentorship, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments, Risk Compliance, Strategic Thinking, Tactical Planning, Technical Credibility The anticipated base pay range for this position is : The anticipated base pay range for this position in the San Francisco Bay Area, CA is $189,000 to $325,450. The anticipated base pay range for this position in U.S. locations is $164,000 to $282,900. Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation -120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year Holiday pay, including Floating Holidays -13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave - 10 days Volunteer Leave - 4 days Military Spouse Time-Off - 80 hours Additional information can be found through the link below. *********************************************
    $189k-325.5k yearly Auto-Apply 12d ago
  • Senior Director, US MedTech Surgery - Field-Based Education

    Johnson & Johnson 4.7company rating

    Raritan, NJ jobs

    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: Customer Management Job Sub Function: External Customer/Product Training Job Category: People Leader All Job Posting Locations: Raritan, New Jersey, United States of America Job Description: We are seeking a dynamic and strategic leader to serve as Senior Director, US MedTech Surgery - Field-Based Education. This role will be responsible for leading all aspects of in-field education, professional education, and commercial education across the US MedTech Surgery business. The ideal candidate will bring deep expertise in surgical education, a passion for innovation, and the ability to drive alignment across stakeholders to deliver impactful learning experiences. This is a field-based, remote role available in all states/cities within the United States. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply. About MedTech Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at *******************/medtech About Surgery Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that's reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world's most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting. Your unique talents will help patients on their journey to wellness. Learn more at *******************/medtech Key Responsibilities: In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position: * Field-Based Education Leadership: Develop and execute a national strategy for in-field education that supports sales teams, clinical specialists, and customer-facing roles. * Professional Education Oversight: Lead the design and delivery of education programs for healthcare professionals, including physicians and non-clinical stakeholders. * Commercial Education Strategy: Align commercial training initiatives with business priorities to drive performance and market growth. * Stakeholder Collaboration: Partner with sales leadership, marketing, clinical teams, and external faculty/KOLs to ensure educational programs are relevant, effective, and aligned. * Innovation & Technology: Integrate modern learning technologies and methodologies to enhance engagement and scalability. * Performance Metrics: Define and monitor KPIs to measure the effectiveness and impact of education programs. * Team Development: Build and lead a high-performing education team, fostering a culture of excellence, agility, and continuous improvement. * Responsible for communicating business-related issues or opportunities to next management level * Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable. * For those who supervise or manage a staff, they are responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable * Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures * Performs other duties assigned as needed Qualifications: * A minimum of a Bachelor's degree is required. * A minimum of 12 years of relevant, industry-related experience with history of success in healthcare medical devices is required * A minimum of 8 years of experience in roles with increasing responsibility (Sales, Sales Management, Marketing, Education, and/or other Commercial Functions) * A minimum of 5 years working on global team or in multiple regions is preferred. * Deep clinical knowledge of MedTech platforms and procedures is required. * A minimum of 7 years of successfully managing a team is required. * Strong influence of management and communications skills working in highly matrixed organizations required. * A valid driver's license in the United States is required. * This role will require up to 70% travel. Additional Qualifications: * Strategic Vision: Ability to translate business goals into actionable education strategies. * Execution Excellence: Proven track record of delivering high-impact programs at both large and small scale. * Customer Insight: Deep understanding of sales reps, managers, and healthcare customers-both clinical and non-clinical. * Innovative Mindset: Creative thinker who challenges the status quo and drives new approaches to learning. * Competitive Drive: Actively engaged in competitive intelligence to ensure differentiation and relevance. * Stakeholder Influence: Skilled at aligning cross-functional teams and confidently guiding direction. * Learning Agility: Eager to explore new ideas and adapt quickly to changing needs. * Capital Selling & Robotics Acumen: Experience or aptitude in complex selling environments, including capital equipment and robotics. * Strong influence management, oral and written communication skills * Ability to develop and lead a team across a matrix organization * Ability to build a global business plan The expected base pay range for this position is $173,000 to $299,000. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis. * Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. * Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). * This position is eligible to participate in the Company's long-term incentive program. * Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: * Vacation -120 hours per calendar year * Sick time - 40 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year * Holiday pay, including Floating Holidays -13 days per calendar year * Work, Personal and Family Time - up to 40 hours per calendar year * Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child * Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member * Caregiver Leave - 10 days * Volunteer Leave - 4 days * Military Spouse Time-Off - 80 hours For additional general information on Company benefits, please go to: * ********************************************* Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please contact us via *******************/contact-us/careers or contact AskGS to be directed to your accommodation resource. Required Skills: Preferred Skills: The anticipated base pay range for this position is : 173-300 Additional Description for Pay Transparency:
    $173k-299k yearly Auto-Apply 11d ago
  • Senior Director, US MedTech Surgery - Field-Based Education

    J&J Family of Companies 4.7company rating

    Raritan, NJ jobs

    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* **Job Function:** Customer Management **Job Sub** **Function:** External Customer/Product Training **Job Category:** People Leader **All Job Posting Locations:** Raritan, New Jersey, United States of America **Job Description:** We are seeking a dynamic and strategic leader to serve as Senior Director, US MedTech Surgery - Field-Based Education. This role will be responsible for leading all aspects of in-field education, professional education, and commercial education across the US MedTech Surgery business. The ideal candidate will bring deep expertise in surgical education, a passion for innovation, and the ability to drive alignment across stakeholders to deliver impactful learning experiences. This is a field-based, remote role available in all states/cities within the United States. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply. About MedTech Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at *******************/medtech About Surgery Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that's reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world's most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting. Your unique talents will help patients on their journey to wellness. Learn more at *******************/medtech Key Responsibilities: In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position: - Field-Based Education Leadership: Develop and execute a national strategy for in-field education that supports sales teams, clinical specialists, and customer-facing roles. - Professional Education Oversight: Lead the design and delivery of education programs for healthcare professionals, including physicians and non-clinical stakeholders. - Commercial Education Strategy: Align commercial training initiatives with business priorities to drive performance and market growth. - Stakeholder Collaboration: Partner with sales leadership, marketing, clinical teams, and external faculty/KOLs to ensure educational programs are relevant, effective, and aligned. - Innovation & Technology: Integrate modern learning technologies and methodologies to enhance engagement and scalability. - Performance Metrics: Define and monitor KPIs to measure the effectiveness and impact of education programs. - Team Development: Build and lead a high-performing education team, fostering a culture of excellence, agility, and continuous improvement. - Responsible for communicating business-related issues or opportunities to next management level - Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable. - For those who supervise or manage a staff, they are responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable - Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures - Performs other duties assigned as needed Qualifications: - A minimum of a Bachelor's degree is required. - A minimum of 12 years of relevant, industry-related experience with history of success in healthcare medical devices is required - A minimum of 8 years of experience in roles with increasing responsibility (Sales, Sales Management, Marketing, Education, and/or other Commercial Functions) - A minimum of 5 years working on global team or in multiple regions is preferred. - Deep clinical knowledge of MedTech platforms and procedures is required. - A minimum of 7 years of successfully managing a team is required. - Strong influence of management and communications skills working in highly matrixed organizations required. - A valid driver's license in the United States is required. - This role will require up to 70% travel. Additional Qualifications: - Strategic Vision: Ability to translate business goals into actionable education strategies. - Execution Excellence: Proven track record of delivering high-impact programs at both large and small scale. - Customer Insight: Deep understanding of sales reps, managers, and healthcare customers-both clinical and non-clinical. - Innovative Mindset: Creative thinker who challenges the status quo and drives new approaches to learning. - Competitive Drive: Actively engaged in competitive intelligence to ensure differentiation and relevance. - Stakeholder Influence: Skilled at aligning cross-functional teams and confidently guiding direction. - Learning Agility: Eager to explore new ideas and adapt quickly to changing needs. - Capital Selling & Robotics Acumen: Experience or aptitude in complex selling environments, including capital equipment and robotics. - Strong influence management, oral and written communication skills - Ability to develop and lead a team across a matrix organization - Ability to build a global business plan The expected base pay range for this position is $173,000 to $299,000. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis. - Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. - Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). - This position is eligible to participate in the Company's long-term incentive program. - Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: - Vacation -120 hours per calendar year - Sick time - 40 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year - Holiday pay, including Floating Holidays -13 days per calendar year - Work, Personal and Family Time - up to 40 hours per calendar year - Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child - Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member - Caregiver Leave - 10 days - Volunteer Leave - 4 days - Military Spouse Time-Off - 80 hours For additional general information on Company benefits, please go to: - ********************************************* Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please contact us via *******************/contact-us/careers or contact AskGS to be directed to your accommodation resource. **Required Skills:** **Preferred Skills:** **The anticipated base pay range for this position is :** 173-300 Additional Description for Pay Transparency:
    $173k-299k yearly 10d ago
  • Director, Strategic Planning

    Merck 4.6company rating

    Boston, MA jobs

    The Enterprise Strategy Office (ESO) develops, implements, and drives enterprise strategy in support of our company, its customers, and other stakeholders. The scope of this group includes strategy development, strategy execution and value realization, enterprise strategic planning, risk management, and strategic venture investments in healthcare as part of our Global Health Innovation fund. Together, we identify business critical opportunities, frame and evaluate options, and ensure effective implementation and cross-functional engagement to realize impact. Oncology is a key area of focus for our company, and our portfolio is large, diverse and evolving rapidly. Within ESO, we provide deep strategic partnership in developing, assessing and shaping our strategy at the portfolio, indication and asset level, as well as the capabilities we need to continue delivering transformative therapies to patients. **Position Description:** The person in this role will help develop and drive Oncology R&D strategy priorities, tackling complex and often ambiguous questions that have significant upside for our Company. They will work with senior leaders to identify and frame important topics, conduct rigorous assessments that can inform leadership decision-making; develop, refine and lead Oncology strategic initiatives across our Company; and help evolve and establish capabilities needed for our Company's Oncology Research & Development to be successful. This individual will collaborate cross-functionally with Oncology leaders across our Company and will be a critical partner across multiple teams. They will be charged with solving problems, driving value, and building a coalition of support that is needed for the creation and adoption of change. This individual will foster a psychologically safe, diverse, and inclusive environment by leading teams both directly and indirectly and mentoring special assignment partners. **Primary Responsibilities:** + Partner with Oncology senior management and leaders to identify high-value strategic imperatives + Lead the framing, assessment, and recommendation of key initiatives in collaboration with executive leaders across oncology + Develop fact-bases using internal and external data sets to support leadership decision making + Interrogate a deep and broad Research & Development portfolio to aid in resource allocation, prioritization and maximization of patient impact + Bring to bear experience in oncology (across discovery, translational sciences, development and commercialization) to identify capability gaps and ways to evolve + Lead internal and external teams to drive ideas from conception to implementation + Partner with cross-functional teams to support implementation and deliver on key objectives + Drive cultural engagement with diverse and inclusive teams **Position Qualifications** **:** **Education and Industry Experience Requirement:** + PhD in a relevant scientific discipline (Oncology preferred) or MD from a top ranked program, equivalent experience considered + 4+ years of strategy management consulting experience from a top-tier firm (e.g., BCG, McKinsey, Bain) or equivalent strategy experience driving R&D programs + Minimum of 5+ years of biopharma-related experience post PhD/MD in a relevant strategy consulting or industry context, with deep expertise in Oncology R&D + Experience managing teams as well as external vendors **Required Skills:** + Advanced degree (or equivalent experience) with demonstrated capability across diverse roles and functions + Problem solving and insight generation - ability to frame and conceptualize complex, ambiguous questions and drive towards clear, substantiated answers relevant to the questions at hand + Strong analytical skills with ability to efficiently interrogate different types of data to deliver relevant, high-quality insights + Strong communicator with excellent verbal and written skills; ability to communicate effectively with senior management and across all levels of the business + Demonstrated leadership qualities with the ability to empathize, listen, and enable other colleagues to thrive + Ability to influence decision-making in a highly matrixed organization + Strong business acumen, with ability to build consensus + Demonstrated ability to prioritize and solve problems, focusing on the highest-impact initiatives + High emotional intelligence; growth mindset with strong curiosity and intrinsic motivation + Collaborative team player who is organized, coachable, and driven to improve **Location** : Rahway, NJ preferred with the potential opportunity for placement in Boston **Required Skills:** Business Strategy Consulting, Collaborating, Communication, Data-Driven Decision Making, Influencing Skills, Leadership, Management Consulting, Oncology, Prioritization, Risk Management, Strategic Thinking, Strategy Development, Strategy Execution, Teamwork Orientation **Preferred Skills:** Current Employees apply HERE (***************************************************** Current Contingent Workers apply HERE (***************************************************** **US and Puerto Rico Residents Only:** Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (*************************************** if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights (****************************************************************************************** EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts (********************************************** **U.S. Hybrid Work Model** Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote". The salary range for this role is $169,700.00 - $267,200.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ****************************************************** . You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. **San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance **Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance **Search Firm Representatives Please Read Carefully** Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. **Employee Status:** Regular **Relocation:** No relocation **VISA Sponsorship:** No **Travel Requirements:** 10% **Flexible Work Arrangements:** Hybrid **Shift:** Not Indicated **Valid Driving License:** No **Hazardous Material(s):** NA **Job Posting End Date:** 12/15/2025 ***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.** **Requisition ID:** R372942
    $169.7k-267.2k yearly 33d ago
  • Director, Strategic Planning

    Merck 4.6company rating

    Cambridge, MA jobs

    The Enterprise Strategy Office (ESO) develops, implements, and drives enterprise strategy in support of our company, its customers, and other stakeholders. The scope of this group includes strategy development, strategy execution and value realization, enterprise strategic planning, risk management, and strategic venture investments in healthcare as part of our Global Health Innovation fund. Together, we identify business critical opportunities, frame and evaluate options, and ensure effective implementation and cross-functional engagement to realize impact. Oncology is a key area of focus for our company, and our portfolio is large, diverse and evolving rapidly. Within ESO, we provide deep strategic partnership in developing, assessing and shaping our strategy at the portfolio, indication and asset level, as well as the capabilities we need to continue delivering transformative therapies to patients. **Position Description:** The person in this role will help develop and drive Oncology R&D strategy priorities, tackling complex and often ambiguous questions that have significant upside for our Company. They will work with senior leaders to identify and frame important topics, conduct rigorous assessments that can inform leadership decision-making; develop, refine and lead Oncology strategic initiatives across our Company; and help evolve and establish capabilities needed for our Company's Oncology Research & Development to be successful. This individual will collaborate cross-functionally with Oncology leaders across our Company and will be a critical partner across multiple teams. They will be charged with solving problems, driving value, and building a coalition of support that is needed for the creation and adoption of change. This individual will foster a psychologically safe, diverse, and inclusive environment by leading teams both directly and indirectly and mentoring special assignment partners. **Primary Responsibilities:** + Partner with Oncology senior management and leaders to identify high-value strategic imperatives + Lead the framing, assessment, and recommendation of key initiatives in collaboration with executive leaders across oncology + Develop fact-bases using internal and external data sets to support leadership decision making + Interrogate a deep and broad Research & Development portfolio to aid in resource allocation, prioritization and maximization of patient impact + Bring to bear experience in oncology (across discovery, translational sciences, development and commercialization) to identify capability gaps and ways to evolve + Lead internal and external teams to drive ideas from conception to implementation + Partner with cross-functional teams to support implementation and deliver on key objectives + Drive cultural engagement with diverse and inclusive teams **Position Qualifications** **:** **Education and Industry Experience Requirement:** + PhD in a relevant scientific discipline (Oncology preferred) or MD from a top ranked program, equivalent experience considered + 4+ years of strategy management consulting experience from a top-tier firm (e.g., BCG, McKinsey, Bain) or equivalent strategy experience driving R&D programs + Minimum of 5+ years of biopharma-related experience post PhD/MD in a relevant strategy consulting or industry context, with deep expertise in Oncology R&D + Experience managing teams as well as external vendors **Required Skills:** + Advanced degree (or equivalent experience) with demonstrated capability across diverse roles and functions + Problem solving and insight generation - ability to frame and conceptualize complex, ambiguous questions and drive towards clear, substantiated answers relevant to the questions at hand + Strong analytical skills with ability to efficiently interrogate different types of data to deliver relevant, high-quality insights + Strong communicator with excellent verbal and written skills; ability to communicate effectively with senior management and across all levels of the business + Demonstrated leadership qualities with the ability to empathize, listen, and enable other colleagues to thrive + Ability to influence decision-making in a highly matrixed organization + Strong business acumen, with ability to build consensus + Demonstrated ability to prioritize and solve problems, focusing on the highest-impact initiatives + High emotional intelligence; growth mindset with strong curiosity and intrinsic motivation + Collaborative team player who is organized, coachable, and driven to improve **Location** : Rahway, NJ preferred with the potential opportunity for placement in Boston **Required Skills:** Business Strategy Consulting, Collaborating, Communication, Data-Driven Decision Making, Influencing Skills, Leadership, Management Consulting, Oncology, Prioritization, Risk Management, Strategic Thinking, Strategy Development, Strategy Execution, Teamwork Orientation **Preferred Skills:** Current Employees apply HERE (***************************************************** Current Contingent Workers apply HERE (***************************************************** **US and Puerto Rico Residents Only:** Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (*************************************** if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights (****************************************************************************************** EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts (********************************************** **U.S. Hybrid Work Model** Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote". The salary range for this role is $169,700.00 - $267,200.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ****************************************************** . You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. **San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance **Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance **Search Firm Representatives Please Read Carefully** Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. **Employee Status:** Regular **Relocation:** No relocation **VISA Sponsorship:** No **Travel Requirements:** 10% **Flexible Work Arrangements:** Hybrid **Shift:** Not Indicated **Valid Driving License:** No **Hazardous Material(s):** NA **Job Posting End Date:** 12/15/2025 ***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.** **Requisition ID:** R372942
    $169.7k-267.2k yearly 33d ago
  • Senior Director, Clinical Research, Atherosclerosis

    Merck 4.6company rating

    Boston, MA jobs

    The Senior Director (Sr. Principal Scientist) has primary responsibility for the planning and directing clinical research activities involving new or marketed medicines in the Atherosclerosis section of the Atherosclerosis & Metabolism therapeutic area. Our company's Atherosclerosis & Metabolism medicines span all phases of clinical development (pre-clinical to post-licensure). The Senior Director will manage the entire cycle of late-stage clinical development and studies, including development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication. **Specifically, the Senior Director May Be Responsible For:** + Evaluating pre-clinical and translational work for the purpose of generating early clinical development plans and Investigational New Drug applications; + Developing clinical development strategies for investigational or marketed Atherosclerosis drugs + Planning clinical trials (design, operational plans, settings) based on these clinical development strategies + Monitoring and managing the conduct of ongoing or new clinical trials for investigational or marketed Atherosclerosis drugs + Analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publication + Participation in internal and joint internal/external research project teams relevant to the development of new compounds, and the further study of marketed compounds. + Support of business development assessments of external opportunities **The Senior Director May:** + Supervise the execution of clinical studies. Work closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects; and assist the Executive Director and/or Associate Vice President in ensuring that appropriate Corporate personnel are informed of the progress of studies of our company and competitors' drugs, and of internal and external expert opinion on scientific questions relevant to his/her areas of responsibility. **The Senior Director is responsible for maintaining a strong scientific fund of knowledge by:** + Maintaining awareness of scientific developments within his/her area of expertise, in terms of new scientific findings, research methodologies + Identifying scientifically and operationally strong investigators who can assist in the development of our company's investigational and marketed drugs + Establishing communications with prominent clinical investigators in his/her particular field of interest, particularly those who will be willing and able to assist in the evaluation of our company's drugs + Attending appropriate scientific meetings to maintain his or her competency and to maintain awareness of research activities in his/her area of responsibility. **To accomplish these goals, the Senior Director may:** + Author detailed development documents, presentations, budgets, and position papers for internal and external audiences + Facilitate collaborations with external researchers around the world + Travel on company business about twenty (20) percent of the time to manage future or ongoing clinical research projects. **Qualifications** **Education** + M.D or M.D./Ph.D. **Required** + Must have experience in industry or as senior faculty in academia + Minimum of 3 years experience in clinical medicine + Minimum of 3-5 year of industry experience in drug development or biomedical research experience in academia + Demonstrated success in overseeing clinical studies and protocols + Demonstrated record of scientific scholarship and achievement + Proven track record in clinical medicine and background in biomedical research + Strong interpersonal skills, as well as the ability to function in a team environment + Outstanding verbal and written communication and presentation skills **Preferred** + Board Certified or Eligible in Cardiology (adult or pediatric), Endocrinology, or Nephrology or related discipline + Prior specific experience in clinical research and prior publication **Required Skills:** Atherosclerosis, Cardiology Clinical Research, Cardiovascular Diseases, Clinical Development, Clinical Studies, Clinical Trial Designs, Clinical Trials Monitoring, General Cardiology, Medical Monitoring, Medical Training, Pharmaceutical Industry, Pharmaceutical Medicine, Research Activities **Preferred Skills:** Current Employees apply HERE (***************************************************** Current Contingent Workers apply HERE (***************************************************** **US and Puerto Rico Residents Only:** Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (*************************************** if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights (****************************************************************************************** EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts (********************************************** **U.S. Hybrid Work Model** Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote". The salary range for this role is $276,600.00 - $435,400.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ****************************************************** . You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. **San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance **Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance **Search Firm Representatives Please Read Carefully** Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. **Employee Status:** Regular **Relocation:** **VISA Sponsorship:** **Travel Requirements:** **Flexible Work Arrangements:** Hybrid **Shift:** **Valid Driving License:** **Hazardous Material(s):** **Job Posting End Date:** 12/19/2025 ***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.** **Requisition ID:** R343075
    $276.6k-435.4k yearly 60d+ ago
  • Senior Director, Cell Therapy Discovery (Cell & Genetic Medicines)

    J&J Family of Companies 4.7company rating

    Spring House, PA jobs

    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* **Job Function:** Discovery & Pre-Clinical/Clinical Development **Job Sub** **Function:** Biotherapeutics R&D **Job Category:** People Leader **All Job Posting Locations:** Cambridge, Massachusetts, United States of America, Remote (US), Spring House, Pennsylvania, United States of America **Job Description:** **About Innovative Medicine** Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at *******************/innovative-medicine We are searching for the best talent for the best Senior Director, Cell Therapy Discovery (Cell & Genetic Medicines) to be in Spring House, PA or Cambridge, MA. Remote work options may be considered on a case-by-case basis and if approved by the Company. **Purpose:** We are seeking a Senior Director of Cell Therapy Discovery to lead and accelerate innovative research efforts in the field of CAR T cell therapies. This leadership role is pivotal in shaping the future of our pipeline and advancing cutting-edge treatments. The ideal candidate will possess extensive expertise in cellular immunology and therapeutic development, with a proven track record of leading discovery teams and delivering impactful results. **You will be responsible for:** + **Strategic Leadership:** Drive the overall strategy and scientific direction of the cell therapy discovery pipeline, aligning with corporate strategy and industry trends. + **Team Management:** Mentor discovery project leaders, and foster a culture of scientific excellence, innovation, and continuous learning. Drive talent development to build capabilities in cutting-edge cell therapy technologies. + **Scientific Innovation:** Identify and execute novel approaches for cell therapy research, including gene editing, innovative transgene design, and delivery strategies. + **External Partnerships:** Establish and manage strategic collaborations with academic institutions, biotech partners, and external CROs to supplement internal expertise, access novel technologies, and accelerate discovery efforts. + **Pipeline Advancement:** Oversee the progression of early-stage discovery programs from ideation through validation, ensuring pipeline robustness and innovation. + **Regulatory & Compliance:** Ensure all research activities adhere to regulatory standards, ethical guidelines, and safety protocols. + **Budget & Resource Planning:** Oversee departmental budgets, resource allocation, and project prioritization to maximize research productivity. **Qualifications:** + PhD or equivalent experience in Cell Biology, Immunology, Bioengineering, or related field. + 12+ years of overall experience in biotech, pharmaceutical, or related academia environments is required; ideally leadership experience in cell therapy discovery is preferred. + Proven track record of innovative scientific contributions, including advancing discovery programs through R&D milestones. + Demonstrated experience leading and developing multidisciplinary teams. + Strong understanding of development considerations in early-stage programs. + Excellent communication, strategic thinking, and collaboration skills. + This role may require 10-20% travel. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (********************************) or contact AskGS to be directed to your accommodation resource. **Required Skills:** **Preferred Skills:** Cell and Gene Therapy, Drug Discovery Development, Drug Discovery Research, Scientific Innovation **The anticipated base pay range for this position is :** $193,000 to $333,500 Additional Description for Pay Transparency: Additional Description for Pay Transparency The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. - Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). - Employees are eligible for the following time off benefits: o Vacation - up to 120 hours per calendar year o Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year o Holiday pay, including Floating Holidays - up to 13 days per calendar year o Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. ********************************************* The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
    $193k-333.5k yearly 30d ago
  • Director, Global Regulatory Leader

    Johnson & Johnson 4.7company rating

    Spring House, PA jobs

    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: Regulatory Affairs Group Job Sub Function: Regulatory Affairs Job Category: Professional All Job Posting Locations: Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America Job Description: About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at *******************/innovative-medicine Johnson & Johnson Innovative Medicine R&D is recruiting for a Director, Global Regulatory Leader. This position is a hybrid role and can be located in Spring House, PA; Titusville, NJ; or Raritan, NJ. Remote work options may be considered on a case-by-case basis and if approved by the Company and will be available in all states within the United States. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply. The Director, Global Regulatory Leader in Global Regulatory Affairs will be responsible for the development, implementation, and maintenance of global regulatory strategies for investigational rare disease and advanced cell therapy products supporting programs in the Immunology Therapeutic Area. Principal Responsibilities: * As the global regulatory lead for assigned projects, develop and implement integrated regulatory strategies and operational plans for investigational rare disease and advanced cell therapy products within the Immunology Therapeutic Area. Ensure strategies are aligned with portfolio objectives, regional regulatory requirements, CMC considerations, commercial goals, and market access plans. * Serve as the key regulatory point of contact, providing leadership and guidance across cross-functional teams to support successful development and commercialization, including providing input on implications of regulatory strategy through participation in product-related teams. * Lead the project Global Regulatory Team (GRT) and participate in the Compound Development Team (CDT) as needed. * Lead and/or participate in meetings with regulatory agencies as appropriate and prepare company personnel for interactions with Health Authorities (HAs). Ensure that responses to FDA questions are handled in a timely manner and in line with the approved product strategy. * Lead and oversee key health authority documents (e.g., IND/CTA, meeting requests, briefing packages, responses, marketing applications) according to the strategic plan for the region and health authority commitments. Perform critical review of submission documents to ensure compliance with regulatory requirements. * Negotiate and manage regional post-approval commitments and global label expansion strategies. * Maintain an understanding of the competitive landscape (e.g., views of HAs, regulatory precedents, labeling differences and disease area-specific issues) and provide proactive strategic regulatory advice to project teams and global regulatory teams. * Maintain working knowledge of laws, guidances and requirements related to autoimmune diseases, in addition to general regulatory knowledge and provide strategic regulatory input into clinical trial designs, labeling, risk management, and development programs to meet global and regional requirements. * Support due diligence and business development assessments. * Identify and resolve regulatory issues that may affect projects or organizational objectives. Qualifications: * A minimum of a Bachelor's degree is required, preferably in a scientific or technical discipline. Advanced degree (Master's, PharmD or PhD) is preferred. * A minimum of 10 years of global health regulated industry is required. * Global regulatory experience with deep expertise in U.S. FDA, EMA, and international regulations within scientific and commercial contexts is required. * Knowledge of the drug product lifecycle from discovery to clinical trials to marketing is required. * An understanding of FDA and International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) regulatory requirements and guidelines specific to the areas of clinical research, product development, and labeling is required. * An understanding of the regulatory submission and approval process is required. * Experience critically reviewing and compiling regulatory documents is required. * Knowledge of the Immunology and Oncology therapeutic areas is strongly preferred. * Knowledge of advanced therapies, such as CAR-T, is strongly preferred. * Demonstrated ability to interpret and apply regulatory requirements and precedents is required. * A proven track record in shaping global regulatory strategies, ensuring compliance, and leading direct interactions with Health Authorities is required. * Must have excellent oral and written communication skills. * Must have strong organization and multi-tasking skills. * A proven track record of working successfully within a collaborative team environment and building positive relationships as an individual contributor is preferred. * The ability to effectively prioritize assignments for multiple products and projects simultaneously is preferred. * The ability to exercise independent judgment and execution in anticipating, evaluating and resolving complex functional and/or complex organizational issues with novel and practical solutions is required. * This position may require up to 10% domestic and international travel. The anticipated base pay range for this position in the San Francisco Bay Area, CA is $189,000 to $325,450. The anticipated base pay range for this position in U.S. locations is $164,000 to $282,900. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/ performance year. Bonuses are awarded at the Company's discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). Employees are eligible for the following time off benefits: * Vacation - up to 120 hours per calendar year * Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year * Holiday pay, including Floating Holidays - up to 13 days per calendar year * Work, Personal and Family Time - up to 40 hours per calendar year For additional general information on company benefits, please go to: ********************************************* The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. This job posting is anticipated to close on December 16, 2025. The Company may however extend this time-period, in which case the posting will remain available on *************************** to accept additional applications. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource. #LI-Hybrid Required Skills: Preferred Skills: Analytical Reasoning, Business Writing, Fact-Based Decision Making, Industry Analysis, Legal Support, Mentorship, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments, Risk Compliance, Strategic Thinking, Tactical Planning, Technical Credibility The anticipated base pay range for this position is : The anticipated base pay range for this position in the San Francisco Bay Area, CA is $189,000 to $325,450. The anticipated base pay range for this position in U.S. locations is $164,000 to $282,900. Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation -120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year Holiday pay, including Floating Holidays -13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave - 10 days Volunteer Leave - 4 days Military Spouse Time-Off - 80 hours Additional information can be found through the link below. *********************************************
    $189k-325.5k yearly Auto-Apply 12d ago
  • Director, Global Regulatory Leader

    J&J Family of Companies 4.7company rating

    Spring House, PA jobs

    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory Affairs **Job Category:** Professional **All Job Posting Locations:** Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America **Job Description:** About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at *******************/innovative-medicine Johnson & Johnson Innovative Medicine R&D is recruiting for a Director, Global Regulatory Leader. This position is a hybrid role and can be located in Spring House, PA; Titusville, NJ; or Raritan, NJ. Remote work options may be considered on a case-by-case basis and if approved by the Company and will be available in all states within the United States. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply. The Director, Global Regulatory Leader in Global Regulatory Affairs will be responsible for the development, implementation, and maintenance of global regulatory strategies for investigational rare disease and advanced cell therapy products supporting programs in the Immunology Therapeutic Area. Principal Responsibilities: + As the global regulatory lead for assigned projects, develop and implement integrated regulatory strategies and operational plans for investigational rare disease and advanced cell therapy products within the Immunology Therapeutic Area. Ensure strategies are aligned with portfolio objectives, regional regulatory requirements, CMC considerations, commercial goals, and market access plans. + Serve as the key regulatory point of contact, providing leadership and guidance across cross-functional teams to support successful development and commercialization, including providing input on implications of regulatory strategy through participation in product-related teams. + Lead the project Global Regulatory Team (GRT) and participate in the Compound Development Team (CDT) as needed. + Lead and/or participate in meetings with regulatory agencies as appropriate and prepare company personnel for interactions with Health Authorities (HAs). Ensure that responses to FDA questions are handled in a timely manner and in line with the approved product strategy. + Lead and oversee key health authority documents (e.g., IND/CTA, meeting requests, briefing packages, responses, marketing applications) according to the strategic plan for the region and health authority commitments. Perform critical review of submission documents to ensure compliance with regulatory requirements. + Negotiate and manage regional post-approval commitments and global label expansion strategies. + Maintain an understanding of the competitive landscape (e.g., views of HAs, regulatory precedents, labeling differences and disease area-specific issues) and provide proactive strategic regulatory advice to project teams and global regulatory teams. + Maintain working knowledge of laws, guidances and requirements related to autoimmune diseases, in addition to general regulatory knowledge and provide strategic regulatory input into clinical trial designs, labeling, risk management, and development programs to meet global and regional requirements. + Support due diligence and business development assessments. + Identify and resolve regulatory issues that may affect projects or organizational objectives. Qualifications: + A minimum of a Bachelor's degree is required, preferably in a scientific or technical discipline. Advanced degree (Master's, PharmD or PhD) is preferred. + A minimum of 10 years of global health regulated industry is required. + Global regulatory experience with deep expertise in U.S. FDA, EMA, and international regulations within scientific and commercial contexts is required. + Knowledge of the drug product lifecycle from discovery to clinical trials to marketing is required. + An understanding of FDA and International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) regulatory requirements and guidelines specific to the areas of clinical research, product development, and labeling is required. + An understanding of the regulatory submission and approval process is required. + Experience critically reviewing and compiling regulatory documents is required. + Knowledge of the Immunology and Oncology therapeutic areas is strongly preferred. + Knowledge of advanced therapies, such as CAR-T, is strongly preferred. + Demonstrated ability to interpret and apply regulatory requirements and precedents is required. + A proven track record in shaping global regulatory strategies, ensuring compliance, and leading direct interactions with Health Authorities is required. + Must have excellent oral and written communication skills. + Must have strong organization and multi-tasking skills. + A proven track record of working successfully within a collaborative team environment and building positive relationships as an individual contributor is preferred. + The ability to effectively prioritize assignments for multiple products and projects simultaneously is preferred. + The ability to exercise independent judgment and execution in anticipating, evaluating and resolving complex functional and/or complex organizational issues with novel and practical solutions is required. + This position may require up to 10% domestic and international travel. The anticipated base pay range for this position in the San Francisco Bay Area, CA is $189,000 to $325,450. The anticipated base pay range for this position in U.S. locations is $164,000 to $282,900. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/ performance year. Bonuses are awarded at the Company's discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). Employees are eligible for the following time off benefits: + Vacation - up to 120 hours per calendar year + Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year + Holiday pay, including Floating Holidays - up to 13 days per calendar year + Work, Personal and Family Time - up to 40 hours per calendar year For additional general information on company benefits, please go to: ********************************************* The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. This job posting is anticipated to close on December 16, 2025. The Company may however extend this time-period, in which case the posting will remain available on *************************** to accept additional applications. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource. \#LI-Hybrid **Required Skills:** **Preferred Skills:** Analytical Reasoning, Business Writing, Fact-Based Decision Making, Industry Analysis, Legal Support, Mentorship, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments, Risk Compliance, Strategic Thinking, Tactical Planning, Technical Credibility **The anticipated base pay range for this position is :** The anticipated base pay range for this position in the San Francisco Bay Area, CA is $189,000 to $325,450. The anticipated base pay range for this position in U.S. locations is $164,000 to $282,900. Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation -120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year Holiday pay, including Floating Holidays -13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave - 10 days Volunteer Leave - 4 days Military Spouse Time-Off - 80 hours Additional information can be found through the link below. *********************************************
    $189k-325.5k yearly 10d ago
  • Director, Financial Planning & Analysis, Corporate Finance

    Vertex Pharmaceuticals, Inc. 4.6company rating

    Boston, MA jobs

    The Director of Corporate Finance is a key member within the Finance organization, responsible for driving short term global planning, forecasting, and reporting processes-including budget development, consolidated performance reporting, and preparation of Board materials. This role partners closely with Finance leadership and cross‑functional stakeholders to provide financial direction and deliver strategic insights that enable achievement of Vertex objectives. The Director leads and develops a team of FP&A professionals, ensuring the delivery of accurate, timely, and actionable financial information that supports executive decision‑making and strengthens shareholder communication. Success in this role requires exceptional communication skills, the ability to distill complex financial data into clear narratives, and the influence to guide decisions across a matrixed organization. Key Responsibilities Team Leadership * Defines and drives the vision for Corporate Finance, aligning planning and reporting processes with Vertex's long-term strategic objectives. Influences enterprise decision-making through actionable insights and thought leadership. * Builds organizational capability by developing future leaders, fostering an inclusive and high-performance culture, and mentoring talent across Finance. Planning & Forecasting * Lead preparation and consolidation of annual budgets, quarterly forecasts, and monthly reporting. * Partner with functional finance teams to align assumptions, ensure accuracy, and support scenario planning and sensitivity analyses. Performance Management & Reporting * Deliver insightful reporting packages and financial analysis for senior management, Executive Committee, and Board presentations. * Monitor KPIs and performance metrics to track progress against corporate and functional goals. Process Optimization & Systems * Leads transformational initiatives to enhance financial planning and analytics processes and capabilities, leveraging technology and innovation to position Vertex for sustainable growth. * Partner with Financial Systems teams to optimize use of Hyperion/BI systems and other tools. Cross‑Functional Collaboration * Collaborate with R&D, Commercial, and Operations finance teams to provide financial guidance for strategic initiatives. * Work closely with Investor Relations, HR, Tax, Treasury, and Accounting to reflect enterprise planning and process optimization. * Lead Corporate Finance SOX processes, partnering closely with Accounting and Internal Audit teams to ensure process controls are maintained and evidenced Required Education Level * Bachelors degree in Finance, Accounting or an equivalent qualification * MBA, CFA or CPA strongly preferred Required Experience * 12+ years of progressive financial management experience, with a heavy emphasis on financial planning and analysis with proven ability to manage complex financial processes * Proven experience operating effectively within a large, complex, and highly regulated global pharmaceutical or biotechnology company. Required Knowledge/Skills * Strong analytical and financial skills to evaluate a broad range of financial questions-especially portfolio analysis, valuation, ROI/ROIC, and complex business questions. * Strong skills demonstrated in MS Office and financial software applications, including Hyperion. * Strong communication, influencing and interpersonal skills necessary for daily interaction with senior management, as well as business partners and peers within Finance. * Demonstrated experience building/developing/leading a high performing team. * Detail-oriented with ability to synthesize big picture story * Ability to lead and drive change in a developing business environment, coordinating processes involving large numbers of people, complex systems, and tight deadlines across multiple time zones. * "Internal consultant mindset" with ability to solve problems through pragmatic, creative approaches * Capability to pro-actively participate in managing within a cross-cultural matrix organization and develop a high performing group of business partners. * Capacity to understand the pharmaceutical industry to address a broad range of challenges and business issues globally across all functions with the ability to make and facilitate quick decisions. * Flexibility and willingness to take on new responsibilities and assist with various ad-hoc projects as needed Pay Range: $182,400 - $273,600 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status: In this Hybrid-Eligible role, you can choose to be designated as: 1. Hybrid: work remotely up to two days per week; or select 2. On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time. #LI-Hybrid Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com
    $182.4k-273.6k yearly Auto-Apply 18d ago
  • Associate Director, Submissions Content Source Management Business Operations Lead (Hybrid role - onsite 3 days per week required)

    Merck 4.6company rating

    Rahway, NJ jobs

    THIS IS A HYBRID ROLE - REQUIREMENT TO WORK WITHIN A COMMUTABLE DISTANCE AND BE ONSITE 3 DAYS PER WEEK) The Submissions Content Source Management Business Operations Lead is expected to understand the end-to-end regulatory submission process. The main focus will be on document production processes, including content authoring, review and finalization, and feed to the Submissions Assembly team. The Business Operations Lead should be able to understand the various source area processes and apply common principles to the cross-functional processes to maintain minimum system complexity while providing high value efficiencies. The Lead will collaborate with cross-functional stakeholders on a daily basis, monitor and evaluate current state, facilitate change planning and drive implementation. **Specific responsibilities of this position include:** + Function as Business System Owner (BSO) of the current Documentum-based global submission content management solution + Co-lead the implementation of the next generation Veeva Vault RIM-based global content source management solution and function as BSO + Lead the Change Management and Business Process activities to drive adoption of the new solution + Support daily operations of the current Documentum-based submission content source management system and the cross-functional user base + Own the business requirements as the BSO and make decisions on requirements and design topics + Support functional areas in identification and review of process questions and issues related to submission content management, quality and standards compliance + Engage across functional areas to identify opportunities for improvement; support the execution of improvement initiatives including business process design, coordination of IT activities, change management and training + Partner with QA and Standards to ensure the content management solution and its associated templates and interfaces adhere to Our Company and Health Authority standards and meet business process requirements + Develop and evaluate metrics as part of a data quality monitoring plan to determine where process improvements or training may be required + Participate in System Development Lifecycle (SDLC) documentation review and maintenance of the business standards for account creation and pre-approved change management + Provide guidance and leadership for M&A activities as it relates to submission content source management; partner with IT and cross-functional SMEs on migration projects **Education:** + Bachelor's degree with a minimum of 10 years of industry experience, at least 6 of those in a regulatory and/or compliance area and experience with technical systems in a regulated environment OR a master's degree and a minimum of 8 years of industry experience at least 6 of those in a regulatory and/or compliance area and experience with technical systems in a regulated environment **Required:** + **Experience with the implementation and operations of a modern** **Veeva RIM Vault A MUST!** + Knowledge of the regulatory submission processes, systems, and business requirements + Experience working closely with IT organizations in the design, development, and implementation of technical systems and tools + Knowledge of system development lifecycle and data administration concepts + Demonstrated experience assessing and enabling process change, especially with cross-functional teams in customer (client) facing roles + Ability to lead and influence others outside of a direct reporting relationship + Broad organizational awareness and knowledge of touch points/interdependencies + Demonstrated Change Management experience, including developing business processes and training documentation + Process Management Knowledge (e.g., Green Belt) + Project Management Skills + Demonstrated capabilities managing and mentoring staff + Strong communication skills (written and verbal), organizational skills and attention to detail **Preferred:** + Experience with other content management systems such as Documentum + Advanced knowledge and capabilities applying technology within a business environment + Sigma Black Belt, Change Management Certification, PMI Certification. **Required Skills:** Adaptability, Adaptability, Business Management, Business Process Consulting, Business Processes, Business Process Improvements, Business Systems, Change Management, Content Management, Content Management Systems (CMS), Cross-Cultural Awareness, Data Management, Data Quality Assessments, Documentation Review, Employee Training Programs, FDA Regulations, IT Coordination, IT Operation, Pharmacovigilance, Policy Implementation, Regulatory Compliance, Regulatory Labeling, Regulatory Operations, Regulatory Submissions, Strategic Thinking {+ 1 more} **Preferred Skills:** Current Employees apply HERE (***************************************************** Current Contingent Workers apply HERE (***************************************************** **US and Puerto Rico Residents Only:** Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (*************************************** if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights (****************************************************************************************** EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts (********************************************** **U.S. Hybrid Work Model** Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote". The salary range for this role is $126,500.00 - $199,100.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ****************************************************** . You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. **San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance **Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance **Search Firm Representatives Please Read Carefully** Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. **Employee Status:** Regular **Relocation:** No relocation **VISA Sponsorship:** No **Travel Requirements:** 10% **Flexible Work Arrangements:** Hybrid **Shift:** Not Indicated **Valid Driving License:** No **Hazardous Material(s):** n/a **Job Posting End Date:** 12/23/2025 ***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.** **Requisition ID:** R362797
    $126.5k-199.1k yearly 60d+ ago
  • Senior Director, Finance Technology (Tax, Treasury, and Accounting)

    Vertex Pharmaceuticals, Inc. 4.6company rating

    Boston, MA jobs

    Vertex is seeking a strategic and collaborative Senior Director, Finance Technology to drive innovation and transformation across Financial Systems, with a focus on Tax, Treasury, and Accounting. This role sits within the Data, Technology & Engineering (DTE) organization and serves as a trusted partner to the CFO organization, aligning technology solutions with business strategies to deliver impactful outcomes. The ideal candidate will bring deep expertise in financial systems, strong stakeholder engagement capabilities, and a passion for enabling change through technology and AI. You will also be close to the technology and have the ability to lead from a technical first perspective in an on-prem environment as we start planning for a potential ERP migration to the cloud. Key Duties and Responsibilities * Lead strategic engagement with senior stakeholders across Tax, Treasury, and Accounting to identify business needs and translate them into technology solutions. * Champion cross-functional collaboration to deliver scalable, compliant, and innovative financial systems aligned with Vertex's enterprise goals. * Own the roadmap for financial systems transformation, ensuring alignment with DTE and CFO strategies. * Drive operational excellence by applying methodologies such as Lean, Six Sigma, and Agile to optimize delivery and system performance. * Serve as a thought leader in financial technology and AI, advising on emerging trends and regulatory implications. * Facilitate change management initiatives to ensure successful adoption of new systems and processes. * Influence and negotiate across matrixed teams to remove barriers and deliver strategic business outcomes. * Ensure ethical stewardship of data and technology assets in compliance with internal policies and external regulations. * Spearhead cloud migration and technology implementations to support efficiencies as well as product launches. Knowledge and Skills * Deep understanding of financial systems and AI architecture and processes across Tax, Treasury, and Accounting. * Proven ability to lead strategic business engagement and influence senior stakeholders. * Expertise in project and portfolio management, including budgeting, resource planning, and risk mitigation. * Strong knowledge of regulatory frameworks and compliance requirements in finance and technology. * Exceptional communication and negotiation skills, with the ability to tailor messaging to diverse audiences. * Demonstrated ability to drive continuous improvement and lead change in complex environments. * Familiarity with data governance, privacy, and security best practices. * Experience with cloud ERP planning and execution projects across various ERPs Education and Experience * Bachelor's degree in Finance, Accounting, Information Systems, or related field or equivalent experience; advanced degree preferred. * Minimum of 12 years of experience in financial systems leadership, including experience in a biotech or regulated industry. * Experience leading cross-functional teams and managing enterprise-level technology initiatives. * Prior experience in a senior leadership role within a DTE or CFO organization is highly desirable. * Experience with both Oracle on-prem as well as SaaS offering from both Oracle and SAP * Experience with cloud technologies (SAP S4 Hana or Oracle Cloud) #LI-hybrid Pay Range: $220,000 - $330,000 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status: In this Hybrid-Eligible role, you can choose to be designated as: 1. Hybrid: work remotely up to two days per week; or select 2. On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time. #LI-Hybrid Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com
    $220k-330k yearly Auto-Apply 20d ago
  • Associate Director, Submissions Content Source Management Business Operations Lead (Hybrid role - onsite 3 days per week required)

    Merck 4.6company rating

    North Wales, PA jobs

    THIS IS A HYBRID ROLE - REQUIREMENT TO WORK WITHIN A COMMUTABLE DISTANCE AND BE ONSITE 3 DAYS PER WEEK) The Submissions Content Source Management Business Operations Lead is expected to understand the end-to-end regulatory submission process. The main focus will be on document production processes, including content authoring, review and finalization, and feed to the Submissions Assembly team. The Business Operations Lead should be able to understand the various source area processes and apply common principles to the cross-functional processes to maintain minimum system complexity while providing high value efficiencies. The Lead will collaborate with cross-functional stakeholders on a daily basis, monitor and evaluate current state, facilitate change planning and drive implementation. **Specific responsibilities of this position include:** + Function as Business System Owner (BSO) of the current Documentum-based global submission content management solution + Co-lead the implementation of the next generation Veeva Vault RIM-based global content source management solution and function as BSO + Lead the Change Management and Business Process activities to drive adoption of the new solution + Support daily operations of the current Documentum-based submission content source management system and the cross-functional user base + Own the business requirements as the BSO and make decisions on requirements and design topics + Support functional areas in identification and review of process questions and issues related to submission content management, quality and standards compliance + Engage across functional areas to identify opportunities for improvement; support the execution of improvement initiatives including business process design, coordination of IT activities, change management and training + Partner with QA and Standards to ensure the content management solution and its associated templates and interfaces adhere to Our Company and Health Authority standards and meet business process requirements + Develop and evaluate metrics as part of a data quality monitoring plan to determine where process improvements or training may be required + Participate in System Development Lifecycle (SDLC) documentation review and maintenance of the business standards for account creation and pre-approved change management + Provide guidance and leadership for M&A activities as it relates to submission content source management; partner with IT and cross-functional SMEs on migration projects **Education:** + Bachelor's degree with a minimum of 10 years of industry experience, at least 6 of those in a regulatory and/or compliance area and experience with technical systems in a regulated environment OR a master's degree and a minimum of 8 years of industry experience at least 6 of those in a regulatory and/or compliance area and experience with technical systems in a regulated environment **Required:** + **Experience with the implementation and operations of a modern** **Veeva RIM Vault A MUST!** + Knowledge of the regulatory submission processes, systems, and business requirements + Experience working closely with IT organizations in the design, development, and implementation of technical systems and tools + Knowledge of system development lifecycle and data administration concepts + Demonstrated experience assessing and enabling process change, especially with cross-functional teams in customer (client) facing roles + Ability to lead and influence others outside of a direct reporting relationship + Broad organizational awareness and knowledge of touch points/interdependencies + Demonstrated Change Management experience, including developing business processes and training documentation + Process Management Knowledge (e.g., Green Belt) + Project Management Skills + Demonstrated capabilities managing and mentoring staff + Strong communication skills (written and verbal), organizational skills and attention to detail **Preferred:** + Experience with other content management systems such as Documentum + Advanced knowledge and capabilities applying technology within a business environment + Sigma Black Belt, Change Management Certification, PMI Certification. **Required Skills:** Adaptability, Adaptability, Business Management, Business Process Consulting, Business Processes, Business Process Improvements, Business Systems, Change Management, Content Management, Content Management Systems (CMS), Cross-Cultural Awareness, Data Management, Data Quality Assessments, Documentation Review, Employee Training Programs, FDA Regulations, IT Coordination, IT Operation, Pharmacovigilance, Policy Implementation, Regulatory Compliance, Regulatory Labeling, Regulatory Operations, Regulatory Submissions, Strategic Thinking {+ 1 more} **Preferred Skills:** Current Employees apply HERE (***************************************************** Current Contingent Workers apply HERE (***************************************************** **US and Puerto Rico Residents Only:** Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (*************************************** if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights (****************************************************************************************** EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts (********************************************** **U.S. Hybrid Work Model** Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote". The salary range for this role is $126,500.00 - $199,100.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ****************************************************** . You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. **San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance **Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance **Search Firm Representatives Please Read Carefully** Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. **Employee Status:** Regular **Relocation:** No relocation **VISA Sponsorship:** No **Travel Requirements:** 10% **Flexible Work Arrangements:** Hybrid **Shift:** Not Indicated **Valid Driving License:** No **Hazardous Material(s):** n/a **Job Posting End Date:** 12/23/2025 ***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.** **Requisition ID:** R362797
    $126.5k-199.1k yearly 60d+ ago
  • Senior Director, Global Development Financial Planning & Analysis

    Vertex Pharmaceuticals, Inc. 4.6company rating

    Boston, MA jobs

    Vertex is growing at a rapid pace with challenging and exciting opportunities for motivated professionals who are keen to contribute to the Vertex mission to invest in scientific innovation to create transformative medicines for people with serious diseases. Our robust and complex R&D pipeline requires a focus on efficiency and prioritization as we scale. The Vertex finance function is integral to achieving our company's strategic goals, providing critical insights and analysis in support of decision-making across the organization. We are investing in our ability to provide data-driven insights by organizing and automating financial data and processes to enable our growing global scale. We are also leveraging best practices to strengthen our business partnering and decision support capabilities. By joining our function, you will become part of a fast-moving, forward-thinking team to support the ongoing growth of a leader in the biotechnology industry. General Summary: The Senior Director, Global Development FP&A is a seasoned finance leader who partners directly with our Global Clinical Development (early- and late-stage programs) organizations and cross-functional program teams to run global financial planning, forecasting, and strategic analysis. Reporting to the VP of R&D Finance, this highly visible role serves as a strategic advisor to the Chief Medical Officer's organization and senior leadership, influencing portfolio prioritization and investment decisions through financial insights. The ideal candidate brings deep expertise in clinical trial finance, executive presence, and a proven ability to drive business outcomes in a dynamic, science-driven environment. This role is for you if you possess strong decision support analytical skills, project management expertise, team management skills, and demonstrated ability to collaborate with cross-functional teams to drive innovation and deliver successful product development outcomes. Key Duties and Responsibilities: A key leader in financial planning and analysis within our function, your responsibilities entail: Advanced Scenario Planning and Risk Analysis: * Build, maintain, and own clinical program-level budgets (Phase 1 to Phase 3), clinical trial cost models, and forecasts; produce cost-to-complete and cost per patient analysis used in strategic decisions. * Lead advanced scenario modeling for clinical programs, including sensitivity analyses on timelines, enrollment rates, and regulatory milestones to inform go/no-go decisions. * Translate clinical development plans into financial implications and ROI-based recommendations. Strategic Influence and Business Partnership: * Participate in cross-functional program teams and governance committees, providing real-time financial guidance. * Deliver program dashboards, KPIs and trend analyses for executive and portfolio reviews. * Prepare and present executive-level updates. Team Leadership: * Lead and develop a team of 6-8 clinical finance professionals: set team priorities, establish processes, and build scalable operating mechanisms for financial support * Drive automation and digital transformation of clinical finance processes, leveraging tools like Hyperion, Oracle, and emerging analytics platforms to improve accuracy and scalability * Mentor staff on forecast accuracy, stakeholder management and financial modeling best practices * Drive a collaborative, service-oriented culture between finance and Global Clinical Development organizations Governance and Compliance Leadership: * Oversee month-end and quarter-end close activities related to clinical expense (accruals, reconciliations, GL review). * Ensure accurate, timely accruals for CROs, FSPs, sites, labs and other clinical vendors. Maintain audit-ready documentation for clinical program spend * Improve transparency and accountability around clinical opex and resource allocation through clear processes, benchmarks and metrics Basic Requirements: * Bachelor's degree in finance, Accounting, or related field; MBA or CPA/CFA strongly preferred. * 12+ years of progressive FP&A experience, with at least 5 years in the pharmaceutical or biotech industry. * Experience supporting R&D or Clinical Development functions at a global scale. * Strong understanding of R&D processes, portfolio management, and project evaluation methodologies. * Proven ability to manage complex budgets, forecasts, and analyses in a dynamic, fast-paced environment. * Excellent communication and presentation skills, with the ability to influence stakeholders at all levels and a proven ability to present complex financial insights to senior stakeholders. Important Knowledge and Skills: * Deep understanding of pharmaceutical industry dynamics and executive-level business partnering. * Hands-on exposure to clinical operations and/or CRO/FSP budgeting. * Strong analytical capabilities in portfolio analysis. * Proficiency in Microsoft Office and financial systems, including Hyperion and Oracle. * Proven ability to lead change in complex, cross-cultural matrix environments. * Exceptional communication and influencing skills across senior leadership and cross-functional teams. * Ability to apply broad market knowledge to drive financial performance and strategic outcomes. * Strategic thinker with attention to detail. #LI-DB1 #HYBRID Pay Range: $212,000 - $318,000 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status: In this Hybrid-Eligible role, you can choose to be designated as: 1. Hybrid: work remotely up to two days per week; or select 2. On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time. #LI-Hybrid Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com
    $212k-318k yearly Auto-Apply 12d ago
  • Medical Affairs Senior Director - Nephrology

    Vertex Pharmaceuticals, Inc. 4.6company rating

    Boston, MA jobs

    The Medical Affairs Senior Director provides medical and scientific leadership in the assigned Therapeutic Area(s) (TA). This role will work closely with a cross-functional group to ensure that scientific and medical strategies are aligned with broader corporate and key stakeholder needs and will ensure the flawless execution of Nephrology medical plans. Key Duties and Responsibilities: * Develops medical affairs plans, including Launch and Life Cycle Management plans * Critically interprets scientific data, determines the potential impact of new research on clinical practice, and uses scientific and clinical data to formulate frameworks and disease management approaches * Shares country/regional insights with global teams to ensure global medical strategies and activities reflect the needs of the country/region * Effectively communicates scientific data through presentations and publications * Provides fair and balanced medical information and education to health care professionals and payers that support the safe and effective use of Vertex drugs in the appropriate patients * Fosters patient access to Vertex drugs, by supporting the commercial organization in the preparation/review of reimbursement dossiers and presenting scientific data as required to key stake holders in the access process * Performs/oversees medical/scientific training for field medical teams, commercial, and other internal stakeholders * Contributes to the local Brand Team, representing the TA (scientific and medical expertise) and ensuring all activities address patient well-being and respect data integrity * Ensures compliance at country level with company policies, medical affairs SOPs, GCP and ICH * Assesses local promotional materials and ensures that all claims are fully supported by scientific data, and are presented in an accurate, fair and balanced manner * Performs/oversees medical/scientific training for Medical, Commercial, and other internal stakeholders Knowledge and Skills: * Deep understanding of global medical, regulatory and commercial (including payer) environments * Excellent understanding of government and industry guidelines, regulations, laws, etc., for appropriate scientific/medical exchange and communication with key external stakeholders (e.g., healthcare providers, payers, advocacy bodies) * Deep understanding of market access in key countries * Excellent written and oral communication skills to influence others internally/externally * Ability to develop relationships in a highly matrixed environment, as well as external relationships with global, regional and local thought leaders and industry experts * Ability to engage in positive dialogue and resolve conflicts in a constructive manner * Track-record of ability to plan, initiate and complete projects within allotted time frames & delivering high quality successful results * Ability to work within a multi-disciplinary and multi-cultural team on common projects and goals, at national and regional level * Capacity to critically analyze current scientific literature Education and Experience: * Terminal scientific degree (e.g., PhD or PharmD) * Typically requires 10 years of experience or the equivalent combination of education and experience Pay Range: $240,000 - $360,000 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status: In this Hybrid-Eligible role, you can choose to be designated as: 1. Hybrid: work remotely up to two days per week; or select 2. On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time. #LI-Hybrid Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com
    $240k-360k yearly Auto-Apply 34d ago
  • Senior Director, Global Medical Affairs - Nephrology

    Vertex Pharmaceuticals, Inc. 4.6company rating

    Boston, MA jobs

    The Medical Affairs Senior Director provides medical and scientific leadership in the assigned Therapeutic Area(s) (TA). This role will work closely with a cross-functional group to ensure that scientific and medical strategies are aligned with broader corporate and key stakeholder needs and will ensure the flawless execution of Nephrology medical plans. Key Duties and Responsibilities: * Critically interprets scientific data and determines the potential impact of new research on scientific and medical understanding of assigned products * Develops medical affairs plans, including Launch and Life Cycle Management plans * Shares country/regional insights with global teams to ensure global medical strategies and activities reflect the needs of the country/region * Provides fair and balanced medical information and education to health care professionals and payers that support the safe and effective use of Vertex drugs in the appropriate patients * Fosters patient access to Vertex drugs, by supporting the commercial organization in the preparation/review of reimbursement dossiers and presenting scientific data as required to key stake holders in the access process * Performs/oversees medical/scientific training for field medical teams, commercial, and other internal stakeholders * Contributes to the local Brand Team, representing the TA (scientific and medical expertise) and ensuring all activities address patient well-being and respect data integrity * Ensures compliance at country level with company policies, medical affairs SOPs, GCP and ICH * Assesses local promotional materials and ensures that all claims are fully supported by scientific data, and are presented in an accurate, fair and balanced manner Knowledge and Skills: * Deep understanding of global medical, regulatory and commercial (including payer) environments * Excellent understanding of government and industry guidelines, regulations, laws, etc., for appropriate scientific/medical exchange and communication with key external stakeholders (e.g., healthcare providers, payers, advocacy bodies) * Deep understanding of market access in key countries * Experience in writing or reviewing scientific communications * Excellent written and oral communication skills to influence others internally/externally * Ability to develop relationships in a highly matrixed environment, as well as external relationships with leaders and industry experts * Track-record of ability to plan, initiate and complete projects within allotted time frames & delivering high quality successful results * Ability to engage in positive dialogue and resolve conflicts in a constructive manner * Ability to work within a multi-disciplinary and multi-cultural team on common projects and goals, at national and regional level Education and Experience: * Terminal scientific degree (e.g., PhD or PharmD) * Typically requires 11 years of experience or the equivalent combination of education and experience Pay Range: $240,000 - $360,000 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status: In this Hybrid-Eligible role, you can choose to be designated as: 1. Hybrid: work remotely up to two days per week; or select 2. On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time. #LI-Hybrid Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com
    $240k-360k yearly Auto-Apply 7d ago
  • Senior Director, Digital Customer Engagement

    Vertex Pharmaceuticals, Inc. 4.6company rating

    Boston, MA jobs

    Vertex is seeking an experienced commercial leader to lead North America's Digital Customer Engagement team. The Senior Director, Digital Customer Engagement will partner with Business Unit leaders and cross-functional stakeholders to implement frictionless and outstanding customer experiences via websites, email, and other digital channels reaching HCPs and patients. This role reports to the Executive Director, North America Commercial Operations. Key Duties and Responsibilities: * Establish the North America commercial digital strategy to complement Business Unit customer facing strategies. Collaborates closely with department peers (Engagement Leads), Business Unit (Heads of Marketing & Sales) and cross-functional stakeholders (DTE) to translate HCP and patient strategies to drive brand utilization and other brand objectives * Identify key digital capabilities gaps yielding more efficient content development and delivery, addressing and anticipating customer needs. Develop a long-range capabilities roadmap to meet emerging business objectives * Leads a team of digital operators and key vendor partners to deliver non-personal promotion tactics efficiently and under budget Partners with a team of digital analysts and key vendor partners to provide strategic recommendations, establish key performance indicators and and tactical performance analysis on non-personal promotional tactics * Leads the development and evolution of a digital operating model to ensure efficient operations across multiple internal and external stakeholders (content transformation, campaign operations across web, email, business roadmap for evolving digital engagement capabilities * Leads the commercial organization's identification and evaluation of digital health opportunities to support business objectives. Provide thought leadership and best practice advocacy to North America Commercial colleagues * Executes business plans for specifically assigned projects Knowledge and Skills: * Demonstrated progression of responsibility and leadership leading change management programs in a matrix organization * Demonstrated excellence in developing commercial digital strategy and tactical implementation, project planning, technology implementation and communication * Demonstrated excellence in HCP and patient marketing in a life sciences organization * Demonstrated ability to develop solutions to complex problems with creativity and innovation * Demonstrated ability in the use of artificial intelligence to advance key business objectives * Proven ability to meet deadlines on multiple projects * Strong and comprehensive understanding of the legal and regulatory environment * Effective communication skills, both verbal and written to negotiate internally/externally often at higher levels * Ability to successfully navigate a fast-paced environment * Ability to manage and lead a highly innovative team aimed at transforming the lives of people with serious diseases, their families and society Education and Experience: * Bachelor's degree in marketing, business or science discipline * MBA preferred * Requires 12 years of experience in pharmaceutical or biotechnology experience, leading omnichannel/digital programs, and 5 years of supervisory/management experience, or equivalent combination of education and experience Pay Range: $225,600 - $338,400 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status: In this Hybrid-Eligible role, you can choose to be designated as: 1. Hybrid: work remotely up to two days per week; or select 2. On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time. Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com
    $225.6k-338.4k yearly Auto-Apply 60d+ ago

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