Senior Vice President jobs at Alnylam Pharmaceuticals - 101 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) 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 : $164,000.00 - $282,900.00 Additional Description for Pay Transparency: 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 Colorado -48 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 Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave - 80 hours in a 52-week rolling period10 days Volunteer Leave - 32 hours per calendar year Military Spouse Time-Off - 80 hours per calendar year For additional general information on Company benefits, please go to: - *********************************************

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: 02/6/2026 *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.

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) 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 : $164,000.00 - $282,900.00 Additional Description for Pay Transparency: 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 Colorado -48 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 Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave - 80 hours in a 52-week rolling period10 days Volunteer Leave - 32 hours per calendar year Military Spouse Time-Off - 80 hours per calendar year For additional general information on Company benefits, please go to: - *********************************************

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:** 02/6/2026 ***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

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:** 02/6/2026 ***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

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) 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 :** $164,000.00 - $282,900.00 Additional Description for Pay Transparency: 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 Colorado -48 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 Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave - 80 hours in a 52-week rolling period10 days Volunteer Leave - 32 hours per calendar year Military Spouse Time-Off - 80 hours per calendar year For additional general information on Company benefits, please go to: - *********************************************

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) 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 : $164,000.00 - $282,900.00 Additional Description for Pay Transparency: 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 Colorado -48 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 Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave - 80 hours in a 52-week rolling period10 days Volunteer Leave - 32 hours per calendar year Military Spouse Time-Off - 80 hours per calendar year For additional general information on Company benefits, please go to: - *********************************************

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

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) 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 : $164,000.00 - $282,900.00 Additional Description for Pay Transparency: 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 Colorado -48 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 Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave - 80 hours in a 52-week rolling period10 days Volunteer Leave - 32 hours per calendar year Military Spouse Time-Off - 80 hours per calendar year For additional general information on Company benefits, please go to: - *********************************************

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

Vertex operates at the forefront of scientific innovation. It has seven approved medicines: five that treat the underlying cause of cystic fibrosis ("CF"), a life-threatening genetic disease, one that treats severe sickle cell disease ("SCD") and transfusion dependent beta thalassemia ("TDT"), and one that treats moderate-to-severe acute pain. Our clinical-stage pipeline includes programs in CF, SCD, beta thalassemia, acute and peripheral neuropathic pain, APOL1-mediated kidney disease, IgA nephropathy and other autoimmune renal diseases and cytopenias, type 1 diabetes, muscular dystrophy, and autosomal dominant polycystic kidney disease. General Summary: The Senior Director, Global Commercial Strategy CF Pipeline Lead is accountable for understanding the evolving needs of the CF Community and Vertex's position within a potentially competitive market, actively contributing to defining the pipeline strategy, pipeline performance goals, and tracking performance against those goals. Key Duties and Responsibilities: * Develops the pipeline strategy (e.g., Next Generation 3.0 and mRNA therapies) and oversees creation of brand strategies and lifecycle activities including data generation to support differentiation and commercialization goals. * Oversees development and implementation of strategic and tactical plans for our next generation CFTR modulators and mRNA therapies * Identifies the commercial opportunity for further serial innovation * Leads team through challenges related to creating external (promotional) communication materials for external use with customers * Provides input into forecasting assumptions and evaluates ROI for activities across the pipeline * Generates and consolidates key insights across HCPs and patient stakeholders (through market research, ad boards, etc.) * Leads the development of brand name for Next Generation 3.0 and VX 522. * Leads the development of strong collaborative partnerships with cross-functional team to support business goals * May lead complex projects that are cross-functional in nature Knowledge and Skills: * Experience defining the strategy for pipeline products in an evolving landscape * Ability to oversee generation of insights, and apply those insights to business problems/opportunities * Analytical mindset, with demonstrated ability to develop strategy, make strategic recommendations, monitor performance, understand ROI and allocate resources * Exceptional working knowledge of market forecasts and relationship of business drivers to revenue * Exceptional working knowledge of MS Office applications, including PPT, Excel and Word * Experience in pharmaceutical marketing, or closely related field(s) (e.g., pharmaceutical sales, ad agency, etc.) Education and Experience: * Bachelor's degree in marketing, business, or scientific degree * Typically requires 12 years of experience or the 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

Vertex operates at the forefront of scientific innovation. It has seven approved medicines: five that treat the underlying cause of cystic fibrosis (“CF”), a life-threatening genetic disease, one that treats severe sickle cell disease (“SCD”) and transfusion dependent beta thalassemia (“TDT”), and one that treats moderate-to-severe acute pain. Our clinical-stage pipeline includes programs in CF, SCD, beta thalassemia, acute and peripheral neuropathic pain, APOL1-mediated kidney disease, IgA nephropathy and other autoimmune renal diseases and cytopenias, type 1 diabetes, muscular dystrophy, and autosomal dominant polycystic kidney disease. General Summary: The Senior Director, Global Commercial Strategy CF Pipeline Lead is accountable for understanding the evolving needs of the CF Community and Vertex's position within a potentially competitive market, actively contributing to defining the pipeline strategy, pipeline performance goals, and tracking performance against those goals. Key Duties and Responsibilities: Develops the pipeline strategy (e.g., Next Generation 3.0 and mRNA therapies) and oversees creation of brand strategies and lifecycle activities including data generation to support differentiation and commercialization goals. Oversees development and implementation of strategic and tactical plans for our next generation CFTR modulators and mRNA therapies Identifies the commercial opportunity for further serial innovation Leads team through challenges related to creating external (promotional) communication materials for external use with customers Provides input into forecasting assumptions and evaluates ROI for activities across the pipeline Generates and consolidates key insights across HCPs and patient stakeholders (through market research, ad boards, etc.) Leads the development of brand name for Next Generation 3.0 and VX 522. Leads the development of strong collaborative partnerships with cross-functional team to support business goals May lead complex projects that are cross-functional in nature Knowledge and Skills: Experience defining the strategy for pipeline products in an evolving landscape Ability to oversee generation of insights, and apply those insights to business problems/opportunities Analytical mindset, with demonstrated ability to develop strategy, make strategic recommendations, monitor performance, understand ROI and allocate resources Exceptional working knowledge of market forecasts and relationship of business drivers to revenue Exceptional working knowledge of MS Office applications, including PPT, Excel and Word Experience in pharmaceutical marketing, or closely related field(s) (e.g., pharmaceutical sales, ad agency, etc.) Education and Experience: Bachelor's degree in marketing, business, or scientific degree Typically requires 12 years of experience or the 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

Job Posting Description As a Sr. Director Biostatistics, you will be at the forefront of cutting-edge medical research, analyzing complex data to unravel crucial insights that may leads to medical breakthroughs You will collaborate with interdisciplinary teams, applying novel statistical methodologies to solve real-world challenges, ultimately contributing to the development of life-saving treatment and improving global well-being. You will be responsible for leadership of a team to plan and execute strategy for this novel therapeutic space from a statistical point of view. The Senior Director, Biostatistics will lead and perform highly scientific statistical functions in support of a company Therapeutic Area, as well as new and complex innovative issues. The Senior Director drives breakthrough results with strategic and technical contributions, while possessing an excellent knowledge of Biostatistics with a drug developer mindset. As a senior leader and people manager within the organization, they will play a crucial role in culture creation, team building, and coaching to direct reports and junior employees across the organization. Responsibilities: • Defines and implements the technical and strategic direction of assigned area of responsibility, guiding technological innovation and process improvements aligned to Biostatistics Functional/Departmental objectives. • Oversees, manages, and directs multiple key projects, providing both strategic and technical expertise, and including clinical trials, observational studies, real world data (RWD) investigations, or other scientific research. • Contributes to drug development strategy including clinical development plans and lifecycle management planning documents. • Develops technical leadership, guides project teams to more meaningful and/or productive ends. Sets the technical and scientific directions of the project(s). • Oversees the delivery of KRMs, conducts senior review of protocols, CSRs, publications, and statistics related documents for regulatory interaction, and approves SAPs. • Contributes or oversees the statistical contributions to external interactions with regulators, payers, review boards, etc. • Key contributor to Statistical Review Forum (SRF) to enable statistical excellence and Biometrics strategic input in study design and planning. • Authors or co-authors methodological or study-related publications and posters. • Leads or oversees development and implementation of innovative designs and analysis methods. • Oversees or contributes in a leading role to departmental working group efforts on various technical and operational issues. • Oversees the performance of project team members, ensuring proper level of scientific rigor, effective team operation and cross-functional collaboration. • May contribute to the management of the biostatistics department as a member of the departmental senior leadership team. • Represents Biostatistics at leadership meetings and senior management reviews. Education & Experience Required: • Ph. D. in Statistics or Biostatistics. • Typically requires 12 years of experience with a Ph.D. or the equivalent combination of education and experience. • Prior people management experience required • Previous project/process leadership experience required • NDA/MAA experience and direct dealings with US or European regulators • Significant expertise with SAS and R statistical software • Demonstrated expertise in advanced/complex statistical methods used in drug development , #LI-AR #LI-Hybrid Pay Range: $226,400 - $339,600 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. 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

General Summary: The Senior Director, Biomarkers, Immunology is an independent leader with wide-reaching scientific knowledge and expertise in immunology and biologics that can drive the biomarker strategy across the immunology portfolio, including in the identification, selection, and development of biomarkers. Experience in authoring and supporting regulatory filings required. The incumbent is an expert in the field of assay development and validation and works with a team and several external CROs to ensure fit-for-purpose validation of biomarker assays. The incumbent is a specialized technical expert in specific areas in biomarker development (e.g. CDx, immunoassays, genomic assays, flow assays, etc.) who can lead specific work streams and capabilities within the group and mentor others within the team. Key Duties and Responsibilities: Leads the development and execution of biomarker strategies in alignment with cross-functional stakeholders and senior management, with a focus on immunology and autoimmune disease programs. Oversees assay development, validation, and execution of biomarker assays across various platforms (e.g., flow assays, immunoassays, genomic assays, NGS, imaging biomarkers) at CROs and internally, providing guidance on data analysis and interpretation. Translates preclinical discoveries into clinical biomarker strategies, identifying mechanism-relevant biomarkers to support drug tailoring hypotheses. Manages and mentors a diverse biomarker team, ensuring alignment of best practices across global sites, including PreClinical Sciences (PCS), Research, Translational, Clinical Development, Clinical Operations, and Bioinformatics teams to ensure robust biomarker strategy execution. Serves as a key liaison with internal and external stakeholders, including diagnostic vendors and scientific partners. Effectively communicates complex biomarker strategies to cross-functional teams and senior leaders. Demonstrates advanced scientific expertise in immunology, biomarker development, and translational medicine. Possesses a strong understanding of the drug development process and showcases enterprise thinking. Experience with late-stage program development is highly preferred. Brings strategic agility and late-stage program experience to adapt to emerging trends in biomarker development. Collaborates across business areas and diverse functional stakeholders to successfully meet project deliverables Knowledge and Skills: Advanced scientific knowledge in immunology, biomarker development, and translational medicine. Experience with autoimmune disease research or immunology therapeutic pipelines. Ability to communicate complex immunology-based biomarker strategies to cross-functional partners and senior leaders, including research, clinical operations, regulatory, program leadership, and non-immunology scientists. Experience with working on cross-functional teams in the biotech/ pharma industry, showcasing enterprise thinking. Has deep knowledge of the drug development process and a broad perspective of the business. Experience with both early and late-stage programs preferred Ability to apply strategic and agile thinking to adapt to the emerging trends in biomarker development/validation. Strong written and verbal communication skills and the ability to effectively communicate with cross-functional teams and present complex science clearly to various stakeholders within the organization. Ability to work collaboratively across business areas and with diverse functional stakeholders to successfully meet project deliverables. Excellent mentor for scientists and employees working on fit-for-purpose assay development Demonstrated expertise with fit-for-purpose assay development Education and Experience: PhD in Immunology, Biochemistry, Molecular Biology, Molecular Pharmacology or related field and 11+ years of experience, or Master's degree and 15+ years of relevant employment experience, or Bachelor's Degree and 20+ years of relevant employment experience. Typically requires 5+ years of managing experience. Demonstrated ability to translate preclinical biomarkers into clinical application. #LI-KM4 Pay Range: $216,800 - $325,200 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

Vertex Pharmaceuticals is seeking an experienced and driven Technology focused Chief of Staff to support our Chief Digital and Information Officer in leading Vertex's digital transformation and IT strategy. This high-impact role functions as a trusted advisor and operational leader for the Office of the CDIO, ensuring that Digital, Data, and Technology initiatives are executed with excellence and aligned with our mission to improve patients' lives. You will drive strategic planning, oversee key initiatives, enhance operational processes, and facilitate cross-functional collaboration. The ideal candidate is a proactive problem-solver with a strong background in digital and technology leadership and exceptional interpersonal skills. Key Duties and Responsibilities: Strategic Planning & Execution Partner with the CDIO to develop and monitor strategic plans, OKRs, and roadmaps. Organize annual and quarterly planning processes for the CDIO organization, ensuring initiatives align with Vertex's corporate strategy and budget. Lead and/or monitor execution of strategic projects and prepare progress reports and readouts for the CDIO and executive team. Executive Support & Decision Enablement Support the CDIO in preparing for key meetings and decisions. Help manage the CDIO's priorities by filtering incoming requests and focusing their attention on the most critical issues. Conduct research and data analysis on technology trends, operational performance, and new opportunities to inform the CDIO's strategy. Develop high-quality presentations, briefing documents, and updates for Executive Committee review, Board discussions, town halls, and other meetings. Operational Excellence Support operationalization of the CDIO organization's strategic plans, including proactive design and development of processes to enable the CDIO's leadership team to achieve their objectives. This may include managing leadership team meetings, agendas, goal setting and reviews, metrics, and team activities. Identify and implement process improvements to optimize the efficiency of the CDIO's organization. Stakeholder Communication & Coordination Facilitate effective communication between the CDIO and other Vertex leaders, as well as within the CDIO's global team. This includes drafting organizational messages and developing a communications strategy to effectively share updates across the function. Special Projects and Initiatives Drive ad-hoc strategic projects as identified by the CDIO. Knowledge and Skills: Expertise in program/project management and operational process improvement Strong understanding of current AI tools and trends around technology platforms in the Pharma industry Strong understanding of IT and digital technology concepts; comfortable discussing software development, data analytics, cloud infrastructure, and cybersecurity Sharp analytical skills, business analysis experience, strategic mindset, and problem-solving ability Exceptional communication, presentation, facilitation, and interpersonal skills Leadership qualities with autonomy, integrity, discretion, resilience, and adaptability Education and Experience: Bachelor's degree in Computer Science, Information Systems, Business Administration or related field or relevant experience MBA or relevant master's degree a plus 10 years of experience or the equivalent combination of education and experience 5+ years experience in IT/digital strategy, technology project management, or related leadership roles Experience in biotech/pharma regulatory environment including GxP, HIPAA, data privacy, and cybersecurity standards Proven experience in a Chief of Staff, Strategy, or Management Consulting role Pay Range: $182,800 - $274,200 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

The Health Economics & Outcomes Research Associate Director will participate in leading the development and execution of Health economics and outcomes research studies in support of Vertex's products. Key Duties and Responsibilities: Leads others to execute complex HEOR evidence generation including, cost-effective analysis and budget impact models, prospective and retrospective observational studies, ITCs, meta-analyses and systematic reviews, patient reported outcomes measure development and validation and other research as needed to support the asset value Gathers and synthesizes insights from Payers, KOLs and HEOR experts; stays current with scientific and policy trends and best practices and applies strategic and content expertise to strategy planning Applies best practices to provide key input to the design of Vertex observational research studies Collaborates with the medical communications teams on publication strategy and ensure that dissemination of HEOR evidence is timely and has maximum impact Partners and works closely with Global Pricing and Market Access to support production of GVD and Value Narrative Knowledge and Skills: Strong track record of publication in peer-reviewed journals Provides technical expertise in HEOR and is able to formulate and lead creative research projects and ensure conduct is technically and scientifically rigorous and reflects best HEOR practices Strong verbal and written communications skills, including presentation skills to communicate difficult concepts and persuade others; comfortable communicating complex concepts and adapting presentation style to a variety of audiences Ability to apply knowledge of US healthcare system, global health technology appraisal requirements, and clinical development, to identify evidence gaps and formulate evidence generation strategies Understanding of the legal and regulatory environment of the pharmaceutical industry, with spotless history of compliance and ethical workplace conduct Education and Experience: Advanced degree (PhD, MD, Master's degree, MPH, or PharmD) in a relevant discipline. Typically requires 8 years of experience, with substantial background in HEOR, or the equivalent combination of education and experience Pay Range: $176,000 - $264,000 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

Vertex is seeking a talented and motivated individual to join its Global Health Economics & Outcomes Research (HEOR) group in Boston, MA. The Health Economics & Outcomes Research Director will lead HEOR strategies and execution of evidence generation that optimize the value proposition of Vertex's povetacicept assets through each stage of development, including launch and post-launch phases. This position reports to the Senior Director Global HEOR Kidney. Key Duties and Responsibilities: Serves as the HEOR povetacicept Lead focusing on pipeline indications: pMN and/or gMG Develops the HEOR strategy for povetacicept from early development through product lifecycle Serves as HEOR lead to cross-functional and cross-regional teams to align strategic plans to stakeholder needs and represent the voice of HEOR Execute complex HEOR evidence generation including, cost-effective analysis and budget impact models, prospective and retrospective observational studies, ITCs, meta-analyses and systematic reviews, patient reported outcomes measure development and validation and other research as needed to support the asset value Gathers and synthesizes insights from Payers, KOLs and HEOR experts; stays current with scientific and policy trends and best practices and applies strategic and content expertise to strategy planning Supports the integration of HEOR evidence in health technology appraisal submissions for relevant assets Collaborates with the medical communications teams on publication strategy and ensure that dissemination of HEOR evidence is timely and has maximum impact Partners and works closely with Global Pricing and Market Access to support production of GVD and Value Narrative Collaborates closely with global brand marketing, clinical, and other functional teams to support and enhance access to marketed products across various regions and serves as HEOR lead to cross-functional teams Oversee the design and execution of HEOR studies and apply best practices for HEOR analyses, modeling and dissemination; ensures the highest quality standards for research and dissemination Knowledge and Skills: Provides technical expertise in HEOR and able to formulate and lead creative research projects and ensure conduct is technically and scientifically rigorous and reflects best HEOR practices Strong track record of publications in peer-reviewed journals demonstrating experience in evidence synthesis, patient reported outcomes, observational research, and health economic modeling Demonstrate capabilities to develop global strategic HEOR plans and execute studies with comprehensive understanding of clinical development strategies and trial designs Ability to apply knowledge of US healthcare system, global health technology appraisal requirements, and clinical development plans, to identify evidence gaps and formulate evidence generation strategies Market Access experience, including direct experience in making submissions to relevant payers and interacting with them is strongly desired (US and EX-US) Strong verbal and written communications skills, including presentation skills to communicate difficult concepts and persuade others; comfortable communicating complex concepts and adapting presentation style to a variety of audiences Broad and comprehensive understanding of the legal and regulatory environment of the pharmaceutical industry, demonstrated integrity on work-related compliance considerations and solid ethics Education and Experience: Advanced degree (PhD, MD, Master's degree, MPH, or PharmD) in a relevant discipline. Typically requires 10 years of experience in health economics and outcomes research, or directly-related field and industry, or the equivalent combination of education and experience Pay Range: $0 - $0 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

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description Overview Gilead Sciences is a research driven biopharmaceutical company committed to delivering lifesaving therapies to patients worldwide. Our teams work collaboratively to advance scientific innovation, accelerate access, and improve health outcomes across major therapeutic areas, including HIV/AIDS, liver diseases, oncology, inflammation, respiratory disease, and cardiovascular conditions. As part of Gilead's global technology and security organization, the Sr. Director, Business Security, Risk & Compliance (SRC) Lead plays a critical role in shaping and securing the digital future of the enterprise. This is a site based role located at our headquarters in Foster City, CA. Remote work is not available for this particular position. We do offer a hybrid schedule of 2 days optional work from home/3 days onsite. Role Summary Reporting to the Chief Information Security Officer (CISO), the Sr. Director, Business Security, Risk & Compliance (SRC) Lead serves as the strategic security partner for Gilead's global business functions. This leader drives digital and AI aligned security strategy, guides secure technology adoption, and ensures risk informed decision making across the enterprise. The role collaborates closely with Information Security, Risk & Compliance leaders, IT Business Engagement, Enterprise Security Architecture, Infrastructure Engineering, Application Development teams, and business stakeholders across all regions. It also provides leadership and oversight for a global team of six security professionals responsible for developing, implementing, and supporting Gilead's information security, risk and compliance capabilities. Core Responsibilities Strategic Leadership & Digital Security Architecture Lead the development and execution of Gilead's digital and AI aligned security strategy. Ensure cyber, AI, and information security risks are identified, assessed, communicated, and effectively managed; escalate material concerns as needed. Translate business, digital, and technology strategies into secure architectural designs and roadmaps. Drive system architecture decisions that balance functionality, service quality, performance, and security. Business Partnership & Digital Enablement Serve as the primary security advisor to global business functions, collaborating to evaluate emerging digital and AI initiatives. Partner with IT Business Engagement teams to understand business priorities, requirements, and technology roadmaps. Influence technology choices to ensure alignment with security standards and regulatory expectations. Technology Strategy, Innovation & Solution Development Evaluate and recommend emerging security technologies, tools, and platforms to enhance Gilead's digital security posture. Lead the definition and evolution of security frameworks, standards, and reference architecture. Drive continuous improvement of security processes, systems, and delivery capabilities. Oversee the design and development of new digital security solutions and enhancements to existing capabilities. Risk Management, Compliance & Controls Ensure digital solutions meet regulatory, risk, and compliance requirements across regions (including EU and APAC). Partner with Security Architecture & Governance and IT Risk & Compliance teams to define effective control requirements and operational implementation. Conduct and oversee security assessments, penetration testing, vulnerability analysis, and remediation efforts. Operational Leadership & Incident Response Guide the deployment and optimization of security technologies including SIEM, IDS/IPS, SecOps tools, endpoint and network security, and firewalls. In the event of a cyber incident, lead coordinated response with SOC, IT teams, and business partners to contain impact and support recovery. Metrics, Reporting & Communication Develop and track key performance indicators that measure the effectiveness of security controls and digital risk posture. Create compelling executive presentations that articulate strategy, risks, solution architectures, and roadmaps to senior leaders and stakeholders. Team Leadership & Talent Development Lead and develop a high performing, globally distributed Security, Risk & Compliance team. Foster an inclusive, collaborative, and innovative team culture aligned with Gilead's core values. Identify, attract, and retain top security talent, including management of external partners, vendors, and academic collaborators. Capabilities & Requirements Technical Expertise Deep mastery of information security principles, architectures, and control frameworks. Strong understanding of digital security, cloud technologies, AIenabled security capabilities, and emerging security trends. Experience with enterprise identity and access management, federated identity, SSO, and related architectures. Proven capability in threat modeling, vulnerability management, forensics, and penetration testing. Leadership & Business Acumen Demonstrated ability to define and articulate a security vision and link it to business priorities. Experience serving as a Business Information Security Officer (BISO) or similar security leadership role in a global organization. Strong communication, influence, facilitation, and negotiation skills across technical and nontechnical audiences. Proven track record leading teams, managing complex environments, and delivering results through collaboration. Additional Qualifications Experience in regulated environments, including SOX, GxP compliant operations. Background in Pharma or Biotech preferred but not required. Competency Strategic Thinking & Business Vision Innovation & Continuous Improvement Global Mindset Stakeholder Management Agility, Adaptability & Tolerance for Ambiguity Influence, Persistence & Accountability Team Leadership & Talent Development Education & Experience Bachelor's degree in computer science, Information Systems, Business, or related field; advanced degree preferred. 10+ years of experience in IT, enterprise applications, or business technology functions. 4-5+ years of experience in cybersecurity, privacy, or risk management leadership roles. Industry certifications such as CISSP or equivalent strongly preferred. Experience in both established enterprises and highgrowth environments is advantageous. Gilead Core Values Integrity - Doing What's Right Inclusion - Encouraging Diversity Teamwork - Working Together Excellence - Being Your Best Accountability - Taking Personal Responsibility Equal Employment Opportunity Gilead Sciences is an equal opportunity employer committed to an inclusive and diverse workforce. Applicants requiring accommodations during the application process may contact ****************** for assistance. The salary range for this position is: $243,100.00 - $314,600.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*. For additional benefits information, visit: ****************************************************************** * Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans. For jobs in the United States: Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance. For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law. Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team. Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion. For Current Gilead Employees and Contractors: Please apply via the Internal Career Opportunities portal in Workday.

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. **Job Description** **Overview** Gilead Sciences is a research driven biopharmaceutical company committed to delivering lifesaving therapies to patients worldwide. Our teams work collaboratively to advance scientific innovation, accelerate access, and improve health outcomes across major therapeutic areas, including HIV/AIDS, liver diseases, oncology, inflammation, respiratory disease, and cardiovascular conditions. As part of Gilead's global technology and security organization, the **Sr. Director, Business Security, Risk & Compliance (SRC) Lead** plays a critical role in shaping and securing the digital future of the enterprise. **This is a site based role located at our headquarters in Foster City, CA. Remote work is not available for this particular position. We do offer a hybrid schedule of 2 days optional work from home/3 days onsite** . **Role Summary** Reporting to the Chief Information Security Officer (CISO), the Sr. Director, Business Security, Risk & Compliance (SRC) Lead serves as the strategic security partner for Gilead's global business functions. This leader drives digital and AI aligned security strategy, guides secure technology adoption, and ensures risk informed decision making across the enterprise. The role collaborates closely with Information Security, Risk & Compliance leaders, IT Business Engagement, Enterprise Security Architecture, Infrastructure Engineering, Application Development teams, and business stakeholders across all regions. It also provides leadership and oversight for a global team of six security professionals responsible for developing, implementing, and supporting Gilead's information security, risk and compliance capabilities. **Core Responsibilities** **Strategic Leadership & Digital Security Architecture** + Lead the development and execution of Gilead's digital and AI alignedsecurity strategy. + Ensure cyber, AI, and information security risks areidentified, assessed, communicated, and effectively managed; escalate material concerns as needed. + Translate business, digital, and technology strategies into secure architectural designs and roadmaps. + Drive system architecture decisions that balance functionality, service quality, performance, and security. **Business Partnership & Digital Enablement** + Serve as the primary security advisor to global business functions, collaborating to evaluate emerging digital and AI initiatives. + Partner with IT Business Engagement teams to understand business priorities, requirements, and technology roadmaps. + Influence technology choices to ensure alignment with security standards and regulatory expectations. **Technology Strategy, Innovation & Solution Development** + Evaluate and recommend emerging security technologies, tools, and platforms to enhance Gilead's digital security posture. + Lead the definition and evolution of security frameworks, standards, and reference architecture. + Drive continuous improvement of security processes, systems, and delivery capabilities. + Oversee the design and development of new digital security solutions and enhancements to existing capabilities. **Risk Management, Compliance & Controls** + Ensure digital solutions meet regulatory, risk, and compliance requirements across regions (including EU and APAC). + Partner with Security Architecture & Governance and IT Risk & Compliance teams to define effective control requirements and operational implementation. + Conduct and oversee security assessments, penetration testing, vulnerability analysis, and remediation efforts. **Operational Leadership & Incident Response** + Guidethe deployment and optimization of security technologies including SIEM, IDS/IPS, SecOps tools, endpoint and network security, and firewalls. + In the event of a cyber incident,lead coordinatedresponsewith SOC, IT teams, and business partners to contain impact and support recovery. **Metrics, Reporting & Communication** + Develop and track key performance indicators that measure the effectiveness of security controls and digital risk posture. + Create compelling executive presentations that articulate strategy, risks, solution architectures, and roadmaps to senior leaders and stakeholders. **Team Leadership & Talent Development** + Lead and develop ahigh performing, globally distributed Security, Risk & Compliance team. + Fosteraninclusive, collaborative, and innovative team culture aligned with Gilead's core values. + Identify, attract, andretaintop security talent, including management of external partners, vendors, and academic collaborators. **Capabilities & Requirements** **Technical Expertise** + Deep mastery of information security principles, architectures, and control frameworks. + Strong understanding of digital security, cloud technologies,AIenabledsecurity capabilities, and emerging security trends. + Experience with enterprise identity and access management, federated identity, SSO, and related architectures. + Proven capability in threat modeling, vulnerability management, forensics, and penetration testing. **Leadership & Business Acumen** + Demonstrated ability to define and articulate a security vision and link it to business priorities. + Experience serving as a Business Information Security Officer (BISO) or similar security leadership role in a global organization. + Strong communication, influence, facilitation, and negotiation skills across technical and nontechnical audiences. + Proventrack recordleading teams, managing complex environments, and delivering results through collaboration. **Additional Qualifications** + Experience in regulated environments, including SOX,GxP compliantoperations. + Background in Pharma or Biotech preferred but notrequired. **Competency** + Strategic Thinking & Business Vision + Innovation & Continuous Improvement + Global Mindset + Stakeholder Management + Agility, Adaptability & Tolerance for Ambiguity + Influence, Persistence & Accountability + Team Leadership & Talent Development **Education & Experience** + Bachelor's degree in computer science, Information Systems, Business, or related field; advanced degree preferred. + 10+ years of experience in IT, enterprise applications, or business technology functions. + 4-5+ years of experience in cybersecurity, privacy, or risk management leadership roles. + Industry certifications such as CISSP or equivalentstronglypreferred. + Experience in both established enterprises andhighgrowthenvironments isadvantageous. **Gilead Core Values** + **Integrity** - Doing What's Right + **Inclusion** - Encouraging Diversity + **Teamwork** - Working Together + **Excellence** - Being Your Best + **Accountability** - Taking Personal Responsibility **Equal Employment Opportunity** Gilead Sciences is an equal opportunity employer committed to an inclusive and diverse workforce. Applicants requiring accommodations during the application process may contact ********************** for assistance. The salary range for this position is: $243,100.00 - $314,600.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*. For additional benefits information, visit: ****************************************************************** * Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans. **For jobs in the United States:** Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance. For more information about equal employment opportunity protections, please view the 'Know Your Rights' (********************************************** poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT (********************************************************* YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law. Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team. Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion. **For Current Gilead Employees and Contractors:** Please apply via the Internal Career Opportunities portal in Workday. Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.