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Senior Director jobs at Moderna

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  • Sr. Director, Litigation

    Moderna 4.8company rating

    Senior director job at Moderna

    The Role: Moderna is seeking a Senior Director, Litigation to lead and manage complex global litigation matters, including product liability defense, government investigations, regulatory enforcement actions, and commercial disputes. This role requires a seasoned litigator with a proven ability to assess, prioritize, and respond to legal risk in a strategic and scalable manner in the biotechnology, pharmaceutical, or life sciences industries. You will be a key legal strategist, advising leadership on high-exposure litigation risks and regulatory challenges while ensuring resources are deployed effectively based on the level of risk. Hands-on in-house experience managing high-stakes government investigations, regulatory enforcement actions, and external counsel in complex litigation is critical. You'll also provide strategic foresight-not just responding to today's risks, but helping the business anticipate and prepare for tomorrow's legal challenges in an increasingly complex global environment. This high-impact role offers meaningful visibility to executive leadership and significant opportunity to shape Moderna's long-term litigation strategy. Here's What You'll Do: Lead and execute Moderna's global litigation strategy, overseeing a diverse portfolio of cases, including product liability, commercial disputes, and government investigations. Assess and prioritize litigation risk, ensuring that responses are proportionate to the level of risk and impact on the business, and advising leadership on when immediate, high-level engagement is required versus when a measured response is appropriate. Act as a lead strategist and decision-maker in high-exposure government investigations, subpoenas, and regulatory enforcement actions, ensuring Moderna's responses are comprehensive, strategic, and aligned with business priorities. Demonstrate extensive hands-on litigation experience, including working directly with outside counsel, overseeing discovery, managing case strategy, and guiding settlement negotiations. Prepare and support Moderna employees for depositions, government interviews, and investigations, ensuring they are well-informed, protected, and aligned with legal strategy. Develop and implement internal protocols for handling subpoenas, regulatory inquiries, and litigation responses to ensure swift, effective decision-making. Proactively assess, prioritize, and mitigate legal risks, collaborating with internal stakeholders in Compliance, Regulatory Affairs, R&D, and Commercial to ensure legal strategies support Moderna's business objectives. Advise senior leadership on high-profile legal matters, litigation trends, and evolving impacting the company's global operations. Become a leader in leveraging generative AI and other advanced technologies in litigation strategy, discovery, and cost management-partnering with external counsel to implement forward-thinking, tech-enabled approaches that drive efficiency, enable favorable outcomes and surface actionable insights. Manage external counsel relationships strategically, ensuring alignment with business goals and optimizing litigation outcomes while maintaining cost-effectiveness. Here's What You'll Bring to the Table: Juris Doctor (JD) from an accredited law school and an active license to practice law in the U.S. 15+ years of litigation experience, with significant in-house experience at a biotechnology, pharmaceutical, or life sciences company and a top-tier law firm specializing in life sciences litigation. Extensive, hands-on experience managing complex litigation matters, including product liability, commercial disputes, and regulatory enforcement actions. Proven success leading responses to government investigations, regulatory inquiries, and enforcement actions from agencies such as the DOJ, FDA, SEC, and foreign regulatory bodies. Exceptional ability to assess, prioritize, and respond to legal risks in a strategic and scalable manner, ensuring the right level of response for each situation. Experience preparing and guiding employees through depositions, government interviews, and internal or external investigations. Track record of leading and managing external counsel, including budget oversight, litigation strategy, and case resolution. An innovation mindset and curiosity around how emerging legal technologies-particularly AI-can be used to reduce cost, improve discovery processes, and surface novel insights. Ability to lead with confidence, discretion, and pragmatism in a high-visibility role where sound judgment and business acumen are paramount. Strong leadership and communication skills, with the ability to advise and influence executive leadership and cross-functional teams in a fast-paced, high-growth environment. Pay & Benefits At Moderna, we believe that when you feel your best, you can do your best work. That's why our US benefits and global well-being resources are designed to support you-at work, at home, and everywhere in between. Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs A holistic approach to well-being, with access to fitness, mindfulness, and mental health support Family planning benefits, including fertility, adoption, and surrogacy support Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown Savings and investment opportunities to help you plan for the future Location-specific perks and extras The salary range for this role is $209,000.00 - $376,000.00. 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 individual's position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs. The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance. About Moderna Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities. We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities. Our Working Model As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact. Moderna is a smoke-free, alcohol-free, and drug-free work environment. Equal Opportunities Moderna 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 or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply! Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. Accommodations We're focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best. Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. 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 contact the Accommodations team at leavesandaccommodations@modernatx.com. Export Control Notice This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant's ability to access export-controlled information in accordance with U.S. law. Only U.S. persons (U.S. citizens, U.S. lawful permanent residents, asylees, or refugees) are currently eligible to access such information without an export license. Candidates who do not meet these criteria may still be considered, contingent on the company's ability to obtain any required export control license. #LI-AG2 -
    $209k-376k yearly Auto-Apply 41d ago
  • Senior Director, Quantitative Systems Pharmacology

    Moderna 4.8company rating

    Senior director job at Moderna

    The Role Moderna's Clinical and Quantitative Pharmacology (CQP) function is seeking an innovative, collaborative, and strategic leader to serve as Senior Director, Head of Quantitative Systems Pharmacology (QSP). In this role, you will provide strategic, scientific, and operational leadership for Moderna's mechanistic and systems pharmacology capabilities. This leader will define and execute the vision for how mechanistic modeling, systems biology, and model-informed drug development (MIDD) approaches are applied across discovery, preclinical, and clinical stages to accelerate development and optimize dose, schedule, patient selection and enable other R&D decisions. You will lead a team of talented modelers and quantitative scientists, collaborate deeply across research, platform sciences, translational, biomarker, DMPK, and clinical functions. Your role will be pivotal in ensuring that QSP strategies and deliverables not only deliver scientific and technical rigor but also strategic insight and cross-functional alignment to accelerate and de-risk Moderna's research/early pipeline. You will also represent Moderna as a thought leader in QSP and translational modeling. Here's What You'll Do Strategic Leadership & Vision Develop and implement QSP strategy across all therapeutic areas and modalities. Embed QSP principles and deliverables into Moderna's R&D decision framework, including target validation, animal study design, human dose projection, and mechanism-of-action understanding. Partner with discovery, preclinical, clinical and platform teams to ensure quantitative and biological hypotheses guide experimental design and portfolio advancement. Represent QSP and champion quantitative and systems-based thinking throughout R&D. Scientific Leadership & Modeling Excellence Lead design, development, and application of mechanistic models (disease progression, target engagement, immune dynamics, biomarker relationships, etc.) to inform key program decisions. Integrate multi-dimensional data and knowledge into multi-scale mechanistic models for translation and decision support. Drive innovation in model architectures and computational methodologies-including hybrid mechanistic + machine-learning approaches, digital-twin development, and virtual population simulations. Ensure scientific rigor, transparency, and reproducibility in all modeling deliverables. Cross-Functional & Stakeholder Leadership Collaborate closely with Clinical Pharmacology, Translational Medicine, DMPK, research, bioinformatics, clinical development and platform sciences to design integrated quantitative strategies. Provide QSP input for INDs, IBs, regulatory filings, and Health Authority interactions. Align modeling deliverables with clinical and quantitative pharmacology to enable model-informed decision-making throughout the molecule lifecycle. Team Leadership & Global Collaboration Build, mentor, and lead a high-performing QSP team including internal team members and external partners. Foster an inclusive, collaborative culture that promotes learning, creativity, and scientific excellence. Define roles, growth paths, and succession plans for the QSP organization; champion professional development. Oversee outsourced modeling work, budget, and strategic partnerships with CROs and academic collaborators. External & Thought Leadership Represent Moderna in global scientific forums, regulatory workshops, and consortia to shape the future of QSP and model-informed drug development. Publish and present scientific work in high-impact journals and conferences. Other Duties As needed, contribute to or lead cross-functional special projects, ad hoc initiatives, or new methodology pilots. Here's What You'll Need (Basic Qualifications) Ph.D. in systems pharmacology, bioengineering, applied mathematics, pharmacology, or a related quantitative discipline. 10 + years of industry or equivalent experience in QSP / mechanistic modeling, with at least 5 years leading teams. Proven track record of applying mechanistic and translational models to support drug development (preclinical through clinical). Deep understanding of PK/PD, systems biology, disease pathway modeling, and biomarker integration. Demonstrated leadership in managing and developing quantitative scientists, preferably across sites or geographies. Proficiency in modeling platforms such as MATLAB/SimBiology, Monolix, R, or Python. Strong communication and influencing skills; ability to translate quantitative findings for multidisciplinary and executive audiences. Experience contributing to regulatory filings and Health Authority interactions leveraging model-informed approaches. Here's What You'll Bring to the Table (Preferred Qualifications) Experience in mRNA or novel therapeutic modalities (e.g. gene therapy, biologics, immuno-oncology). Familiarity with PBPK modeling, virtual populations, or digital-twin simulation. Experience building infrastructure or toolchains for scalable modeling and data integration. Track record of scientific publications and external visibility. A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative. Pay & Benefits At Moderna, we believe that when you feel your best, you can do your best work. That's why our US benefits and global well-being resources are designed to support you-at work, at home, and everywhere in between. Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs A holistic approach to well-being, with access to fitness, mindfulness, and mental health support Family planning benefits, including fertility, adoption, and surrogacy support Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown Savings and investment opportunities to help you plan for the future Location-specific perks and extras The salary range for this role is $196,700.00 - $353,400.00. 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 individual's position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs. The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance. About Moderna Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities. We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities. Our Working Model As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact. Moderna is a smoke-free, alcohol-free, and drug-free work environment. Equal Opportunities Moderna 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 or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply! Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. Accommodations We're focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best. Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. 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 contact the Accommodations team at leavesandaccommodations@modernatx.com. Export Control Notice This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant's ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license. #LI-NH1 -
    $196.7k-353.4k yearly Auto-Apply 29d ago
  • Senior Director, Cell Therapy Discovery (Cell & Genetic Medicines)

    Johnson & Johnson 4.7company rating

    Cambridge, MA jobs

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

    Amgen 4.8company rating

    Remote

    Career CategoryBusiness DevelopmentJob DescriptionJoin Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Director of External Research & Development - Technology Business DevelopmentWhat you will do Let's do this! Let's change the world! In this vital role you as the Business Development Director within the External R&D Technology group, this role is responsible for leading Amgen's search and evaluation, as well as negotiate and execute on certain transactions, for external partnerships focusing on small molecule drug discovery, as well as technologies that support oncology therapeutic area. Collaborating with cross-functional teams to ensure alignment with the business's broader goals will also be a critical part of your role. The successful candidate will contribute to and execute on Amgen's external strategy and develop and nurture a global network of key industry and academic contacts to ensure robust communication of ideas, interests and information between the external community and internal groups. The role requires proactive efforts to manage the search and identification of opportunities through networking and reviews of the external landscape and prioritizing based on Amgen's R&D strategy. The role includes leading the technical evaluations of opportunities by creating and managing cross-functional review teams, providing recommendations based on robust scientific and drug industry knowledge, and ensuring appropriate and efficient decision-making processes. This person will ensure efficient reviews and engage in business negotiations, and working with the legal team to execute contractual agreements for certain projects. The candidate will be responsible for leading strategic discussions and presentations, collaborating closely with senior management, R&D, and other functions to develop a set of priorities for collaboration, license, or M&A of external innovation. The Director of External Research & Development - Technology Business Development will also be expected to contribute in search and evaluation and transactions for technology areas outside of small molecule drug discovery and oncology, as needs arise, as well as mentor others and present himself/herself as a thoughtful and respected professional to both internal colleagues and external parties. It's highly preferred that this role be located at an Amgen Research hub in either South San Francisco, CA or Thousand Oaks, CA to match most of our research teams. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The Director of External Research & Development - Technology Business Development will have these qualifications. Basic Qualifications: Doctorate degree in a scientific field & 4 years of experience in drug development industry and/or biopharma business development Or Master's degree in a scientific field & 7 years of experience in drug development industry and/or biopharma business development Or Bachelor's degree in a scientific field & 9 years of experience in R&D and/or biopharma business development Preferred Qualifications: Doctorate in scientific field, with strong knowledge in discovery and technology platforms 4+ years of management and/or leadership experience in business and drug development activities, and strong technical R&D experience along with business development and licensing experience. Strong leadership, scientific, organizational, communication, and project management skills and ability to manage multiple projects simultaneously. Excellent presentation skills. Effective communication skills pertaining to scientific and business development. Must demonstrate ability to foresee and solve problems, and prioritize and meet deadlines. Strong team player, experience in successfully managing direct reports and a demonstrated ability to interface effectively with all-levels of staff across differing functional expertise. Demonstrated ability to create and establish relationships with internal and external parties. Professional demeanor with strong decision making Be able to work independently, manage large cross functional teams, and mentor individuals. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans Flexible work models, including remote and hybrid work arrangements, where possible Apply now and make a lasting impact with the Amgen team.careers.amgen.com In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. Application deadline Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. . Salary Range 194,497.00 USD - 230,061.00 USD
    $129k-177k yearly est. Auto-Apply 10d ago
  • Senior Director, Cell Therapy Discovery (Cell & Genetic Medicines)

    J&J Family of Companies 4.7company rating

    Spring House, PA jobs

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

    J&J Family of Companies 4.7company rating

    Raritan, NJ jobs

    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* **Job Function:** Customer Management **Job Sub** **Function:** External Customer/Product Training **Job Category:** People Leader **All Job Posting Locations:** Raritan, New Jersey, United States of America **Job Description:** We are seeking a dynamic and strategic leader to serve as Senior Director, US MedTech Surgery - Field-Based Education. This role will be responsible for leading all aspects of in-field education, professional education, and commercial education across the US MedTech Surgery business. The ideal candidate will bring deep expertise in surgical education, a passion for innovation, and the ability to drive alignment across stakeholders to deliver impactful learning experiences. This is a field-based, remote role available in all states/cities within the United States. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply. About MedTech Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at *******************/medtech About Surgery Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that's reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world's most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting. Your unique talents will help patients on their journey to wellness. Learn more at *******************/medtech Key Responsibilities: In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position: - Field-Based Education Leadership: Develop and execute a national strategy for in-field education that supports sales teams, clinical specialists, and customer-facing roles. - Professional Education Oversight: Lead the design and delivery of education programs for healthcare professionals, including physicians and non-clinical stakeholders. - Commercial Education Strategy: Align commercial training initiatives with business priorities to drive performance and market growth. - Stakeholder Collaboration: Partner with sales leadership, marketing, clinical teams, and external faculty/KOLs to ensure educational programs are relevant, effective, and aligned. - Innovation & Technology: Integrate modern learning technologies and methodologies to enhance engagement and scalability. - Performance Metrics: Define and monitor KPIs to measure the effectiveness and impact of education programs. - Team Development: Build and lead a high-performing education team, fostering a culture of excellence, agility, and continuous improvement. - Responsible for communicating business-related issues or opportunities to next management level - Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable. - For those who supervise or manage a staff, they are responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable - Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures - Performs other duties assigned as needed Qualifications: - A minimum of a Bachelor's degree is required. - A minimum of 12 years of relevant, industry-related experience with history of success in healthcare medical devices is required - A minimum of 8 years of experience in roles with increasing responsibility (Sales, Sales Management, Marketing, Education, and/or other Commercial Functions) - A minimum of 5 years working on global team or in multiple regions is preferred. - Deep clinical knowledge of MedTech platforms and procedures is required. - A minimum of 7 years of successfully managing a team is required. - Strong influence of management and communications skills working in highly matrixed organizations required. - A valid driver's license in the United States is required. - This role will require up to 70% travel. Additional Qualifications: - Strategic Vision: Ability to translate business goals into actionable education strategies. - Execution Excellence: Proven track record of delivering high-impact programs at both large and small scale. - Customer Insight: Deep understanding of sales reps, managers, and healthcare customers-both clinical and non-clinical. - Innovative Mindset: Creative thinker who challenges the status quo and drives new approaches to learning. - Competitive Drive: Actively engaged in competitive intelligence to ensure differentiation and relevance. - Stakeholder Influence: Skilled at aligning cross-functional teams and confidently guiding direction. - Learning Agility: Eager to explore new ideas and adapt quickly to changing needs. - Capital Selling & Robotics Acumen: Experience or aptitude in complex selling environments, including capital equipment and robotics. - Strong influence management, oral and written communication skills - Ability to develop and lead a team across a matrix organization - Ability to build a global business plan The expected base pay range for this position is $173,000 to $299,000. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis. - Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. - Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). - This position is eligible to participate in the Company's long-term incentive program. - Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: - Vacation -120 hours per calendar year - Sick time - 40 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year - Holiday pay, including Floating Holidays -13 days per calendar year - Work, Personal and Family Time - up to 40 hours per calendar year - Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child - Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member - Caregiver Leave - 10 days - Volunteer Leave - 4 days - Military Spouse Time-Off - 80 hours For additional general information on Company benefits, please go to: - ********************************************* Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please contact us via *******************/contact-us/careers or contact AskGS to be directed to your accommodation resource. **Required Skills:** **Preferred Skills:** **The anticipated base pay range for this position is :** 173-300 Additional Description for Pay Transparency:
    $173k-299k yearly 23h ago
  • Senior Director, Quantitative Pharmacology

    Regeneron Pharmaceuticals 4.9company rating

    Cambridge, MA jobs

    We are looking for a Senior Group Director in Quantitative Pharmacology. This individual will be responsible for managing a team functioning in one or more therapeutic focus area. In this capacity the SGD is accountable for the successful and timely completion of QP related activities, encompassing a broad array of deliverables in support of Drug Safety and Pharmacometrics. The successful applicant will support a range of assets from Early Clinical Development through submission and beyond. This position can be based in our Tarrytown, NY, Warren, NJ or Cambridge, MA offices. A day in the life of a Senior Group Director may look like: * Managing and mentoring a broad spectrum of individual contributing scientists. * Providing technical guidance and mentoring of colleagues within the function and across the organization. * Performance management and assessment of staff and providing guidance and training to enable their success. * Utilizing a mastery level of PK/PD knowledge and strategic leadership skills, effectively developing and implementing strategic analyses in support of research and development projects. * Taking accountability for the PK/PD evaluation of a portfolio of products or projects, and/or highly complex projects that are wide in scope. * Identifying opportunity for process and procedural improvements, product or service improvements. * Solving unique and complex problems that have a broad impact on the business. This may be the right role for you, if you: * Can inspire and lead colleagues to deliver PMx and company goals. * Want the ability to make a significant impact on the organization and external groups, and can influence and effect change. * Enjoy making contributions to multi-disciplinary meetings by sharing cross-functional skills and knowledge. * Understand long-term career opportunities and can guide other QP staff on potential directions. In order to be considered qualified for this role, you must have: * 10+ years of industry experience (with a Ph.D.) or 12+ years (with an M.S.), focusing on modeling and simulation, PK/PD (pharmacokinetics/pharmacodynamics), systems pharmacology, and quantitative drug development strategies. * Hands on usage of a broad range of quantitative tools and systems is required, as is a strong publication record in the field. * A proven ability to display excellent interpersonal and communication skills both written and oral and ability to communicate complex information succinctly. * Strong collaborative skills and effective at building alliances across functions, as well as the ability to effectively influence colleagues and multi-disciplinary project teams. * The ability to handle all types of projects and leverage higher level staff for technical input and brainstorming to implement solutions for complex projects. * Proven experience interacting with regulatory agencies without supervision, and within the company to develop regulatory strategy. #REGNQPCP Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels! Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. Salary Range (annually) $238,400.00 - $397,300.00
    $238.4k-397.3k yearly Auto-Apply 60d+ ago
  • Senior Director, Advanced Informatics Lead

    Regeneron Pharmaceuticals 4.9company rating

    Uxbridge, MA jobs

    Regeneron's growing portfolio is accompanied by ever-increasing amounts of research and clinical data. We are seeking a leader in advanced analytics who can harness the power and insights within our data to improve Global Development (GD), making it more productive while delivering medicines to patients more efficiently and rapidly. Working with a team of data scientists, this position will develop both strategic and technical approaches to improve data access and quality; develop and implement AI/ML algorithms for predictive and descriptive analytics; and advise the GD organization on its overall data strategy. This position will be a key leader in GD's Digital Transformation (DT) efforts and will work closely with the DT lead to address scientific and informatics challenges. This position will also be a liaison between the DT group and the broader scientific community in GD and all of Regeneron. As a Senior Director, a typical day may include: * Establish and implement advanced analytical strategies to extract maximum value from our data. This may include answering clinical questions, using predictive analytics in trial design, automating document analysis and generation, automating development processes, etc. * Supervise the development of prototype systems and approaches that, in partnership with IT, can scale to be used on an enterprise level * Lead a team of data scientists and developers to create the technical tools and pipelines necessary to implement advanced analytic solutions * Drive the development and implementation of cutting-edge analytic solutions, fostering seamless integration and strategic alignment across GD and other Regeneron business units (e.g., Commercial, Research, etc.) to enhance data-driven decision-making and organizational synergy. * Collaborate with external partners (vendor, academic, scientific, etc.) to develop and implement relevant solutions * Provide scientific and informatics leadership to GD's digital transformation strategy with an additional focus on organizational change management. Proven ability to lead organizational change, particularly in adopting new technologies and processes, is a plus. * Present the advanced analytic strategy to diverse stakeholders across GD and Regeneron and have the ability to influence senior executive leadership and non-technical audiences * Develop KPIs to demonstrate the impact of advanced analytic strategies on GD cycle times and other relevant outcomes To be considered for this opportunity, you must have the following: * Proven track-record of developing and scaling advanced analytic solutions and advanced analytic strategies and programs in a healthcare or life sciences organization. * Demonstrated experience working with large-scale, complex datasets, particularly in the regulated healthcare or clinical trial setting; understanding of clinical data standards is preferred. * Demonstrated experience leading teams and overseeing multiple analytical projects, with a focus on guiding the development and implementation of AI/ML solutions. * Proven ability to develop and align data strategies that optimize data utilization, support organizational goals, and drive actionable insights. * Expertise in Python, R, or other programming languages, with a focus on applying advanced technical skills to data analysis, automation, and software development. Candidates should demonstrate proficiency in writing efficient, scalable, and maintainable code. * Proven expertise in evaluating and validating advanced analytic algorithms, ensuring accuracy, reliability, and reproducibility in clinical and research applications. Skilled in developing frameworks for model validation, enhancing data quality, and implementing quality assurance protocols. * A research track record with academic publications and/or academic grant support is preferred. * Strong analytical and communication skills. * May require travel up to 20%. Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit ********************************************************************* For other countries' specific benefits, please speak to your recruiter. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron's roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's on-site policy and expectations for your role and your location. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. Salary Range (annually) $238,400.00 - $397,300.00
    $238.4k-397.3k yearly Auto-Apply 21d ago
  • Senior Director, R&D Data Science & Digital Health - Neurodegeneration

    Johnson & Johnson 4.7company rating

    Cambridge, MA jobs

    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: Data Analytics & Computational Sciences Job Sub Function: Data Science Portfolio Management Job Category: People Leader All Job Posting Locations: Cambridge, Massachusetts, United States of America, San Diego, California, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America Job Description: 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 is recruiting for Senior Director, R&D Data Science & Digital Health - Neurodegeneration. This position can be located in one of our office locations in either Cambridge, MA (preferred), Spring House, PA, Titusville, NJ, or San Diego, CA. May require approximately 25% domestic and international travel. 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 *******************/. Role Summary We are seeking an experienced and visionary Senior Director to lead our data science and digital health strategy for neurodegenerative diseases. This role will shape and execute innovative approaches leveraging multiomics, digital health technologies, artificial intelligence, and clinical/real-world evidence (RWE) to accelerate drug discovery, development, and patient impact. You will partner closely with Neuroscience Therapeutic Area, Clinical Development, Quantitative Sciences, Regulatory and Patient Reported Outcomes as well as external collaborators to drive a precision neuroscience agenda. This position offers the opportunity to transform how we understand disease biology, identify novel endpoints, stratify patients, and deliver better outcomes for people living with neurodegenerative disorders. Key Responsibilities * Define and execute the data science and digital health strategy for neurodegeneration, integrating computational biology, AI/ML, digital health, and clinical/RWE insights. * Drive the application of multiomics (genomics, proteomics, transcriptomics, metabolomics, etc.) and integrative analytics to uncover disease mechanisms, biomarkers, and novel targets. * Lead the development, validation, and regulatory engagement of digital tools and novel endpoints to enhance clinical trial design, patient monitoring, and care pathways. * Champion the use of machine learning, deep learning, generative and agentic AI to accelerate patient stratification, disease modeling, and translational discovery. * Partner with clinical development and medical affairs to integrate RWE into evidence generation, supporting trial optimization, regulatory submissions, and real-world impact assessment. * Build strong cross-functional and external collaborations with academic groups, technology providers, regulators, and consortia to position the company at the forefront of data-driven neuroscience. * Recruit, develop and inspire a diverse team of digital health scientists, RWE experts and computational neuroscientists to deliver on strategic initiatives. Qualifications * Advanced degree (PhD, MD or equivalent) in neuroscience / quantitative sciences such as biomedical engineering, data science, biostatistics, computational biology or a related field is required. * 10+ years of relevant industry or academic experience, with proven leadership in applying data-driven methods to drug discovery and development is required. * 7+ years of experience as a people manager is required. * Experience in clinical development with demonstrated expertise in neurodegeneration preferred. * Excellent communication skills, with the ability to translate complex data-driven insights into clear strategies for senior stakeholders and external partners is required. * Technical Expertise in as least two of the three following areas is required: 1. Proficiency in multiomics integration (e.g., genomics, transcriptomics, proteomics,) and advanced statistical/causal inference methods; 2. Expertise in applying digital health technologies (wearables, sensors, mobile platforms) and novel endpoints in clinical research. 3. Experience with large-scale clinical datasets, EHR, and real-world data and expertise in advanced modeling, longitudinal analysis, and patient stratification. * Track record of scientific contributions (presentations and publications) in this field is required. * Familiarity with data standards, privacy regulations, and regulatory qualification pathways is required. * Knowledge of data infrastructures, development of data analysis pipelines and their implementation at scale, and state-of-the-art AI methodologies is a plus. * Competence with programming and analytics environments (e.g., Python, R) with ability to guide technical teams at a strategic level is required. * Demonstrated success in leading cross-disciplinary teams at the interface of data science, biology, and clinical development is required. This position currently has the option to follow a hybrid schedule of 3 days per week working on-site and 2 days per week working remotely (no fully remote option available) and can be located in one of our office locations in either Cambridge, MA, Spring House, PA, Titusville, NJ, or San Diego. May require approximately 25% travel domestic and international. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please contact us via *******************/contact-us/careers or internal employees contact AskGS to be directed to your accommodation resource. The anticipated base pay range for this position is $193,000 to $333,500. 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 Holiday pay, including Floating Holidays - up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. ********************************************* The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. #LI-SL #JNJDataScience #JNJIMRND-DS #JRDDS #LI-Hybrid
    $193k-333.5k yearly Auto-Apply 29d ago
  • Senior Director, R&D Data Science & Digital Health - Ophthalmology

    Johnson & Johnson 4.7company rating

    Cambridge, MA jobs

    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: Data Analytics & Computational Sciences Job Sub Function: Data Science Portfolio Management Job Category: People Leader All Job Posting Locations: Cambridge, Massachusetts, United States of America, San Diego, California, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America Job Description: 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 is recruiting for Senior Director, R&D Data Science & Digital Health - Ophthalmology. This position can be located in one of our office locations in either Cambridge, MA (preferred), Spring House, PA, Titusville, NJ, or San Diego, CA. May require approximately 25% domestic and international travel. 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 *******************/. Role Summary We are seeking an experienced and visionary Senior Director to lead our data science and digital health strategy for ophthalmology. This role will shape and execute innovative approaches leveraging multiomics, digital health technologies, artificial intelligence, and clinical/real-world evidence (RWE) to accelerate drug discovery, development, and patient impact. You will partner closely with Neuroscience Therapeutic Area, Clinical Development, Quantitative Sciences, Regulatory and Patient Reported Outcomes as well as external collaborators to drive a precision neuroscience agenda. This position offers the opportunity to transform how we understand disease biology, identify novel endpoints, stratify patients, and deliver better outcomes for people living with ophthalmic disorders. Key Responsibilities * Define and execute the data science and digital health strategy for ophthalmology, integrating computational biology, AI/ML, digital health, and clinical/RWE insights. * Drive the application of multiomics (genomics, proteomics, transcriptomics, metabolomics, etc.) and integrative analytics to uncover disease mechanisms, biomarkers, and novel targets. * Lead the development, validation, and regulatory engagement of digital tools and novel endpoints to enhance clinical trial design, patient monitoring, and care pathways. * Champion the use of machine learning, deep learning, generative and agentic AI to accelerate patient stratification, disease modeling, and translational discovery. * Partner with clinical development and medical affairs to integrate RWE into evidence generation, supporting trial optimization, regulatory submissions, and real-world impact assessment. * Build strong cross-functional and external collaborations with academic groups, technology providers, regulators, and consortia to position the company at the forefront of data-driven science. * Recruit, develop and inspire a diverse team of digital health scientists, RWE experts and computational scientists to deliver on strategic initiatives. Qualifications * Advanced degree (PhD, MD or equivalent) in neuroscience / quantitative sciences such as biomedical engineering, data science, biostatistics, computational biology or a related field is required. * 10+ years of relevant industry or academic experience, with proven leadership in applying data-driven methods to drug discovery and development is required. * 7+ years of experience as a people manager is required. * Experience in clinical development with demonstrated expertise in ophthalmology preferred. * Excellent communication skills, with the ability to translate complex data-driven insights into clear strategies for senior stakeholders and external partners is required. * Technical Expertise in as least two of the three following areas is required: 1. Proficiency in multiomics integration (e.g., genomics, transcriptomics, proteomics,) and advanced statistical/causal inference methods; 2. Expertise in applying digital health technologies (wearables, sensors, mobile platforms) and novel endpoints in clinical research. 3. Experience with large-scale clinical datasets, EHR, and real-world data and expertise in advanced modeling, longitudinal analysis, and patient stratification. * Track record of scientific contributions (presentations and publications) in this field is required. * Familiarity with data standards, privacy regulations, and regulatory qualification pathways is required. * Knowledge of data infrastructures, development of data analysis pipelines and their implementation at scale, and state-of-the-art AI methodologies is a plus. * Competence with programming and analytics environments (e.g., Python, R) with ability to guide technical teams at a strategic level is required. * Demonstrated success in leading cross-disciplinary teams at the interface of data science, biology, and clinical development is required. This position currently has the option to follow a hybrid schedule of 3 days per week working on-site and 2 days per week working remotely (no fully remote option available) and can be located in one of our office locations in either Cambridge, MA, Spring House, PA, Titusville, NJ, or San Diego. May require approximately 25% travel domestic and international. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please contact us via *******************/contact-us/careers or internal employees contact AskGS to be directed to your accommodation resource. The anticipated base pay range for this position is $193,000 to $333,500. 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 Holiday pay, including Floating Holidays - up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. ********************************************* The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. #LI-SL #JNJDataScience #JNJIMRND-DS #JRDDS #LI-Hybrid
    $193k-333.5k yearly Auto-Apply 29d ago
  • Senior Director, R&D Data Science & Digital Health - Neuropsychiatry

    Johnson & Johnson 4.7company rating

    Cambridge, MA jobs

    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: Data Analytics & Computational Sciences Job Sub Function: Data Science Portfolio Management Job Category: People Leader All Job Posting Locations: Cambridge, Massachusetts, United States of America, San Diego, California, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America Job Description: 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 is recruiting for Senior Director, R&D Data Science & Digital Health - Neuropsychiatry. This position can be located in one of our office locations in either Cambridge, MA (preferred), Spring House, PA, Titusville, NJ, or San Diego, CA. May require approximately 25 % domestic and international travel. 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 *******************/. Role Summary We are seeking an experienced and visionary Senior Director to lead our data science and digital health strategy for neuropsychiatry. This role will shape and execute innovative approaches leveraging multiomics, digital health technologies, artificial intelligence, and clinical/real-world evidence (RWE) to accelerate drug discovery, development, and patient impact. You will partner closely with Neuroscience Therapeutic Area, Clinical Development, Quantitative Sciences, Regulatory and Patient Reported Outcomes as well as external collaborators to drive a precision neuroscience agenda. This position offers the opportunity to transform how we understand disease biology, identify novel endpoints, stratify patients, and deliver better outcomes for people living with neuropsychiatric disorders. Key Responsibilities * Define and execute the data science and digital health strategy for neuropsychiatry, integrating computational biology, AI/ML, digital health, and clinical/RWE insights. * Drive the application of multiomics (genomics, proteomics, transcriptomics, metabolomics, etc.) and integrative analytics to uncover disease mechanisms, biomarkers, and novel targets. * Lead the development, validation, and regulatory engagement of digital tools and novel endpoints to enhance clinical trial design, patient monitoring, and care pathways. * Champion the use of machine learning, deep learning, generative and agentic AI to accelerate patient stratification, disease modeling, and translational discovery. * Partner with clinical development and medical affairs to integrate RWE into evidence generation, supporting trial optimization, regulatory submissions, and real-world impact assessment. * Build strong cross-functional and external collaborations with academic groups, technology providers, regulators, and consortia to position the company at the forefront of data-driven neuroscience. * Recruit, develop and inspire a diverse team of digital health scientists, RWE experts and computational neuroscientists to deliver on strategic initiatives. Qualifications * Advanced degree (PhD, MD or equivalent) in neuroscience / quantitative sciences such as biomedical engineering, data science, biostatistics, computational biology or a related field is required. * 10+ years of relevant industry or academic experience, with proven leadership in applying data-driven methods to drug discovery and development is required * 7+ years of experience as a people manager is required * Experience in clinical development with demonstrated expertise in neuropsychiatry is preferred. * Excellent communication skills, with the ability to translate complex data-driven insights into clear strategies for senior stakeholders and external partners is required. * Technical Expertise in as least two of the three following areas is required: 1. Proficiency in multiomics integration (e.g., genomics, transcriptomics, proteomics,) and advanced statistical/causal inference methods; 2. Expertise in applying digital health technologies (wearables, sensors, mobile platforms) and novel endpoints in clinical research. 3. Experience with large-scale clinical datasets, EHR, and real-world data and expertise in advanced modeling, longitudinal analysis, and patient stratification. * Track record of scientific contributions (presentations and publications) in this field is required. * Familiarity with data standards, privacy regulations, and regulatory qualification pathways is required. * Knowledge of data infrastructures, development of data analysis pipelines and their implementation at scale, and state-of-the-art AI methodologies is a plus. * Competence with programming and analytics environments (e.g., Python, R) with ability to guide technical teams at a strategic level is required. * Demonstrated success in leading cross-disciplinary teams at the interface of data science, biology, and clinical development is required. This position currently has the option to follow a hybrid schedule of 3 days per week working on-site and 2 days per week working remotely (no fully remote option available) and can be located in one of our office locations in either Cambridge, MA, Spring House, PA, Titusville, NJ, or San Diego. May require approximately 25% travel domestic and international. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please contact us via *******************/contact-us/careers or internal employees contact AskGS to be directed to your accommodation resource. The anticipated base pay range for this position is $193,000 to $333,500. 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 Holiday pay, including Floating Holidays - up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. ********************************************* The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. #LI-SL #JNJDataScience #JNJIMRND-DS #JRDDS #LI-Hybrid
    $193k-333.5k yearly Auto-Apply 31d ago
  • Senior Director, Head of Hematology R&D Data Science & Digital Health

    Johnson & Johnson 4.7company rating

    Cambridge, MA jobs

    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: Data Analytics & Computational Sciences Job Sub Function: Data Science Portfolio Management Job Category: Professional All Job Posting Locations: Cambridge, Massachusetts, United States of America, New Brunswick, New Jersey, United States of America, Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America Job Description: Johnson and Johnson Innovative Medicine (J&J IM), a pharmaceutical company of Johnson & Johnson is recruiting for a Senior Director, Head of Hematology R&D Data Science & Digital Health. This position has a primary location of Spring House, PA but is also open to Cambridge, MA; Titusville; NJ, Raritan, NJ; or New Brunswick, NJ. The position requires 25% travel. 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 This role will direct and lead efforts to deliver innovative end-to-end Data Science & Digital Solutions to the Oncology Hematology portfolio. This will include both early and late stage pipeline assets. This person will lead a team aimed at supporting the Clinical Development Teams (CDTs) with the full spectrum of Data Science capabilities, such as novel endpoints, real-world evidence, and digital diagnostics using AI/ML and other appropriate methods. This role will lead clinical-stage therapies such as Darzalex, Tecvayli and Talvey. Additional responsibilities include capability and talent development, resource management and deployment, and supporting an organizational culture that promotes data-driven decision-making across all functions of Johnson & Johnson Innovative Medicine - R&D Oncology. You will be a thought leader within Janssen R&D in the field of applied use of innovative methodologies in clinical trials. The Applicant will: * Be responsible for leading a team of Data Scientists who partner with cross functional Compound Development Teams for clinical-stage hematologic cancers in building and implementing Data Science plans to support clinical/research objectives throughout the trial lifecycle. * Data Science applications will include Real-World Evidence, cell profiling, clinical phenotyping, computer vision/medical imaging that leverage technologies such as statistical methodologies, AI/Machine learning techniques (e.g. Generative AI). * Actively manage a team to communicate Data Science plans for Compound Development Teams. This will include seeking and managing feedback with internal and external stakeholders and developing fit-for-purpose studies serving CDT objectives. * Develop data, analytic and reporting requirements for Data Science-related projects for the CDTs. This will include both regulatory-grade and observational research. * Identify and procure data sets and technologies for bespoke applications. Manage external partnerships. * Work with clinical and internal Data Science teams and external partners to execute analytics and report results. The candidate will be responsible for liaising with external partners including regulatory agencies. * The candidate will be responsible for communicating and interpreting scientific results, as well as projecting implications of Data Science research. Qualifications: * Advance degree in Health Science (Ph.D or MD) or Masters Degree, Pharm D with equivalent work experience with data analysis, interpretation and experimental design. A background in one or more of the following areas is beneficial: clinical oncology, computational research, pharmaco-epidemiology, statistics, outcomes research or related field in health care area. * 8+ years of health-care related research, such as disease/clinical phenotyping, outcomes research, clinical genomics * Strong working knowledge of drug development, with established expertise with one or more components of drug development, such as translational research, clinical studies, or regulatory interactions. * Familiarity with healthcare relevant datasets, such as EHR/RWD, genomics, insurance claims * Capacity to manage timelines and drive key deliverables in a matrix environment. * Established leadership skills, including management of individuals and teams working towards common clinical/scientific goals * Prior experience working and driving external partnerships, either corporate or academic * Ability to effectively communicate technical work to a wide audience. * Team leadership either preferably as a line function leader or in some cases leader in a matrix environment Preferred: * Experience with digital heath outcome solutions for Oncology therapies. * Prior experience serving on multifunctional teams delivering clinical trials in an R&D or Medical Affairs setting. * Proficiency with regulatory submissions and interaction. * Experience with novel, innovative approaches to drug development, such as Generative AI.s Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (********************************) or contact AskGS to be directed to your accommodation resource. The anticipated base pay range for this position is $173,000 to $299,000 Additional Description for Pay Transparency 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)). This position is eligible to participate in the Company's long-term incentive program. 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 #JRDDS #JNJDataScience #JNJIMRND-DS Required Skills: Preferred Skills: The anticipated base pay range for this position is : Additional Description for Pay Transparency:
    $173k-299k yearly Auto-Apply 2d ago
  • R&D Director, Industrialization

    Merck 4.6company rating

    Bedford, MA jobs

    Work Your Magic with us! Start your next chapter and join MilliporeSigma. Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us. This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US. Your Role: We are seeking a highly experienced and results-driven Director of R&D - Industrialization to lead the successful transition of innovative single-use technologies and bioprocessing systems from product development into full-scale manufacturing. This role will serve as the critical interface between R&D and Operations, ensuring new product introductions (NPIs) are scalable, cost-effective, manufacturable, and automation-ready at commercial volumes. The ideal candidate will combine deep technical knowledge of single-use technologies and bioprocessing systems with a strong background in manufacturing, design for automation, and cost optimization strategies. Key Responsibilities: Lead Industrialization Efforts: Own the design transfer and industrialization strategy for new single-use products and bioprocessing systems. Ensure manufacturing readiness, quality standards, and regulatory compliance. Manufacturability & Automation Readiness: Drive Design for Manufacturability (DFM) and Design for Automation (DFA) principles early in the development process to enable efficient, scalable, and automated manufacturing solutions. Apply modularization and platforming strategies to reduce cost, complexity, time to market, and order lead time. Cost Optimization: Collaborate with Supply Chain, Procurement and Product Management to ensure that products meet cost targets through value engineering, automation strategies, material selection, and optimized assembly processes. Cross-functional Liaison: Act as the key point of contact between R&D and Manufacturing teams to proactively address manufacturability, automation challenges, and scale-up issues during development and post-launch. Process & Automation Development: Partner with Engineering and Automation teams within the Manufacturing network to define and validate automated or semi-automated assembly processes aligned with product design and volume expectations. Risk Mitigation: Identify and mitigate technical and operational risks related to new product industrialization through robust testing, pilot builds, and DFMEA/PFMEA processes. Stage-Gate Leadership: Own industrialization milestones within the product development process, including gate deliverables for manufacturability, automation readiness, and production scalability. Sustaining Engineering Interface: Support the resolution of manufacturability and automation issues on existing products by providing R&D insights into root cause analysis and continuous improvement initiatives. Who You Are Minimum Qualifications: Bachelor's or Master's degree in Mechanical Engineering, Chemical Engineering, Biotechnology, or related field. Advanced degree preferred. 10+ years in R&D, process development, or industrialization roles within bioprocessing, life sciences, or medical device industries. 5+ years of experience in leadership roles with cross-functional team oversight. Proven experience with development and/or manufacturing of single-use technologies (e.g. bioreactors, filtration systems, fluid management etc.) Preferred Qualifications: Strong understanding of GMP manufacturing environments, quality systems, and regulatory requirements. Deep experience with designing for automation, including part geometry optimization, fixture design, and integration with robotic or semi-automated systems. Proficiency in DFM/DFA principles, lean manufacturing, process validation, and cost modeling. Demonstrated ability to guide cross-functional teams through complex design and transfer activities. Excellent communication, problem-solving, and organizational skills. Travel: Up to 25% domestic and international travel to development sites, manufacturing facilities, and suppliers. Pay Range for this position: $159,700 - $271,600 The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here. What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress! Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!
    $159.7k-271.6k yearly 60d+ ago
  • Senior Manager, Global Patient Safety - Immunology & Inflammation

    Regeneron Pharmaceuticals 4.9company rating

    Uxbridge, MA jobs

    The Senior Manager of Global Patient Safety (GPS) will play a key scientific role in safety strategies for molecules in clinical development and post-marketing phases in the assigned Therapeutic Area. We will expect this to include safety data aggregation, review and analysis to support appropriate safety interpretation and benefit-risk assessment. In this role, a typical day might include: * Complete signal detection activities in line with approved safety surveillance plan * Perform signal evaluation for any identified signals and author the safety evaluation reports * Manage preparation and review of safety documents including DSUR, PSUR, RMP, response to health authority or other queries * Prepare and deliver presentations at Signal Management Team (SMT) meetings; participate in clinical study team meetings for assigned compounds * Participate in other risk management activities as appropriate for assigned compounds * We may ask you to represent GPS on cross-functional teams, including Regeneron Safety Oversight Committee (RSOC), Independent Data Monitoring Committees (IDMC) and other teams with members external to Regeneron * Actively participate in process improvement initiatives e.g. the development and maintenance of relevant SOPs, WIs and supporting documents This role might be for you if can/have the: * Ability to apply relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments * Ability to work with a safety system database for purposes of medical case review and simple queries * Able to be proactive and self-disciplined, you can meet deliverables, and effectively use your time and prioritize * Ability to effectively communicate (verbal and written) safety findings To be considered for this opportunity, you must have the following: * Minimum a Master's, PhD, or PharmD * Offers 7+ years of relevant risk management experience in the pharmaceutical/ biotech industry or health authority #GDPSJobs Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit ********************************************************************* For other countries' specific benefits, please speak to your recruiter. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron's roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's on-site policy and expectations for your role and your location. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. Salary Range (annually) $148,300.00 - $241,900.00
    $148.3k-241.9k yearly Auto-Apply 4d ago
  • Senior Manager, Advanced Informatics

    Regeneron Pharmaceuticals 4.9company rating

    Uxbridge, MA jobs

    Global Development is embarking on a digital transformation project that will incorporate AI, machine learning, and automation into our processes to help us reduce cycle times, improve quality, and allow us to focus on more meaningful work. The Senior Manager, Advanced Informatics will play a key part in facilitating that transformation, linking clinical operations with technology. This position will provide strategic guidance while working with diverse teams to ensure that Regeneron can extract the maximum value from its data resources in developing AI/ML based solutions. This person will also play a major role in analyzing our data, communicating the results of the analysis, and implementing changes based on those results. This position will combine both scientific and technical knowledge to develop approaches and architectures for digital transformation while aligning with similar efforts across Regeneron. They will also work with external partners and organizations to maintain and improve data quality and to broaden the use of data standards throughout our processes. As a Senior Manager, a typical day may include: * Help develop and implement the clinical informatics strategy to optimize Global Development's data resources for AI/ML and advanced analytics * Provide strategic and operational guidance to data engineers and architects, including technical and application development related to GD data resources * Collaborate with teams across GD to identify clinical informatics use cases and implement solutions. * Organize and analyze diverse clinical data sets to solve specific GD-related questions and identify opportunities to increase efficiencies * Scale AI/ML and informatics projects to the enterprise level with cross-functional teams * Work with external data partners to optimize data standards for ingestion and exchange * Work effectively between technical and non-technical groups in Development and across Regeneron to bridge science and technology and implement a comprehensive data strategy * Evaluate tools and platforms and contribute to build vs. buy decisions * Inform and educate colleagues across GD regarding clinical informatics To be considered for this opportunity, you must have the following: * Proven track-record of developing and scaling advanced analytic solutions and advanced analytic strategies and programs in a healthcare or life sciences organization * Preferred: formal training in biomedical informatics or the equivalent experience * Demonstrated experience working with large-scale, complex datasets, particularly in the regulated healthcare or clinical trial setting; understanding of clinical data standards is preferred. Experience with electronic health record (EHR) data is also preferred. * Demonstrated experience architecting and building analytic pipelines, including those focused on data quality * Deep knowledge of AI/ML -based analytic approaches and strategies, including experience programming in Python, R or other equivalent * Experience leading multi-disciplinary teams including partnering with local or enterprise IT organizations * Strong analytical and communication skills * May require travel up to 20% Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit ********************************************************************* For other countries' specific benefits, please speak to your recruiter. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron's roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's on-site policy and expectations for your role and your location. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. Salary Range (annually) $148,300.00 - $241,900.00
    $148.3k-241.9k yearly Auto-Apply 21d ago
  • Senior Manager Clinical Study Lead (Cell Therapy)

    Regeneron Pharmaceuticals 4.9company rating

    Uxbridge, MA jobs

    The Senior Clinical Study Lead (CSL) is expected to operate with high-degree of independence and is accountable for the global execution of assigned large and/or complex clinical trials from study design, through execution, to study close out. The Senior CSL is accountable for the study timelines, study budget, and ensuring study conduct is in accordance with Regeneron Standard Operating Procedures (SOPs) and ICH/GCP. This role applies to internally sourced studies and studies out-sourced to Clinical Research Organizations (CROs) and the balance of direct leadership versus oversight will vary accordingly. Contributes and drives ongoing process improvement initiatives. This role is not eligible fully remote. This role is required to be onsite in one of our locations. (Armonk, NY / Warren, NJ / Cambridge, MA / Dublin, Ireland / Uxbridge, London) A typical day in this role looks like: * Leads the cross-functional study team responsible for clinical study delivery and is the primary point of contact of leadership and oversight (as required) for the assigned study * Provides operational input into protocol development * Oversees and provides input to the development of study specific documentation including but not limited to: case report forms (CRF), data management plan, monitoring plan, monitoring oversight plan, project specific training plan, data review plan, statistical analysis plan, etc. * Oversees set-up and maintenance of study systems including but not limited to Clinical Trial Management System (CTMS), Trial Master File (TMF) etc. * Ensures compliance with the clinical trial registry requirements * Identifies outsourcing needs of the study and leads and oversees engagement, contracting and management of required vendors * Provides input into baseline budget development and management * Provides input into baseline timeline development and management * Leads risk assessment and identifies risk mitigation strategies at the study level * Leads the feasibility assessment to select relevant regions and countries for the study * Oversees/conducts site evaluation and selection * Leads investigator meeting preparation and execution * Monitors progress for site activation and monitoring visits and acts on any deviations from plan * Leads the development of and oversees implementation of patient recruitment and retention strategies and acts on any deviations from plan * Monitors data entry and query resolution and acts on any deviations from agreed metrics * Ensures accurate budget management and scope changes for internal and external studies * Oversees and provides input to the study drug and clinical supplies forecasting, drug accountability and drug reconciliation * Escalates issues related to study conduct, quality, timelines or budget to Program Operations Leader (POL) and other stakeholders and develops and implements appropriate actions to address issues * Oversees the execution of the clinical study against planned timelines, deliverables and budget * Oversees data quality including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations, and suspected serious non-compliance by sites * Oversees and ensures the CROs and Third Party Vendors are in alignment and are delivering per the scope of work * Ensure clinical project audit and inspection readiness through the study lifecycle * Supports internal audit and external inspection activities and contributes to CAPAs as required * Manages and oversees study close-out activities including but not limited to database lock, reconciliation of vendor contracts, budget, TMF, and study drug accountability * Contributes to clinical study report writing and review * Facilitates and contributes to study level lessons learned * Assigns tasks to Clinical Study Management staff and supports their deliverables * Recommends and participates in cross-functional and departmental process improvement initiatives * Responsible for identification of innovative approaches to clinical study execution including global considerations and continuous improvement of CTM SOPs * May be assigned unmasked tasks for studies, which may include but is not limited to, assisting with masked investigational product, set up and management of unmasked trial master file, review of unmasked data in the electronic data capture system, point of contact for IVRS issues, and support oversight of unmasked clinical monitoring * Responsible for direct supervision of CTM staff. Line management responsibilities include work assignments, performance management, staff recruitment, professional development, coaching, mentoring, ongoing training and compliance, and study support/oversight * May require 25% travel This role may be for you if you have: * Exceptional interpersonal & leadership skills * Applies advanced expertise and implements the operational strategic direction and guidance for respective clinical studies * Demonstrates expert knowledge and a data driven approach to planning, executing, and problem solving * Advanced communication skills via verbal, written and presentation abilities * Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization * Ability to influence and negotiate across a wide range of stakeholders * Strong budget management experience * An awareness of relevant industry trends * Ability to build, lead and develop productive study teams and collaborations * Applies advanced negotiation and interpersonal skills to vendor management * Advanced technical proficiency in trial management systems and MS applications including (but not limited to) Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC * Extensive experience in global clinical trial operations with unique knowledge and skills to contribute to the development of protocols and key study documents * Knowledge of ICH/GCP and regulatory guidelines/directives * Advanced project management skills, cross-functional team leadership and organizational skills * Line management experience In order to be considered qualified, a minimum of a Bachelor's degree is required and a minimum of 8 years relevant clinical trial experience. A background in clinical trials within cell therapy is highly preferred Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels! Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. Salary Range (annually) $148,300.00 - $241,900.00
    $148.3k-241.9k yearly Auto-Apply 56d ago
  • Senior Manager Clinical Study Lead (Oncology)

    Regeneron Pharmaceuticals 4.9company rating

    Uxbridge, MA jobs

    The Senior Clinical Study Lead (CSL) is expected to operate with high-degree of independence and is accountable for the global execution of assigned large and/or complex clinical trials from study design, through execution, to study close out. The Senior CSL is accountable for the study timelines, study budget, and ensuring study conduct is in accordance with Regeneron Standard Operating Procedures (SOPs) and ICH/GCP. This role applies to internally sourced studies and studies out-sourced to Clinical Research Organizations (CROs) and the balance of direct leadership versus oversight will vary accordingly. Contributes and drives ongoing process improvement initiatives. This role is not eligible fully remote. This role is required to be onsite in one of our locations. A typical day in this role looks like: * Leads the cross-functional study team responsible for clinical study delivery and is the primary point of contact of leadership and oversight (as required) for the assigned study * Provides operational input into protocol development * Oversees and provides input to the development of study specific documentation including but not limited to: case report forms (CRF), data management plan, monitoring plan, monitoring oversight plan, project specific training plan, data review plan, statistical analysis plan, etc. * Oversees set-up and maintenance of study systems including but not limited to Clinical Trial Management System (CTMS), Trial Master File (TMF) etc. * Ensures compliance with the clinical trial registry requirements * Identifies outsourcing needs of the study and leads and oversees engagement, contracting and management of required vendors * Provides input into baseline budget development and management * Provides input into baseline timeline development and management * Leads risk assessment and identifies risk mitigation strategies at the study level * Leads the feasibility assessment to select relevant regions and countries for the study * Oversees/conducts site evaluation and selection * Leads investigator meeting preparation and execution * Monitors progress for site activation and monitoring visits and acts on any deviations from plan * Leads the development of and oversees implementation of patient recruitment and retention strategies and acts on any deviations from plan * Monitors data entry and query resolution and acts on any deviations from agreed metrics * Ensures accurate budget management and scope changes for internal and external studies * Oversees and provides input to the study drug and clinical supplies forecasting, drug accountability and drug reconciliation * Escalates issues related to study conduct, quality, timelines or budget to Program Operations Leader (POL) and other stakeholders and develops and implements appropriate actions to address issues * Oversees the execution of the clinical study against planned timelines, deliverables and budget * Oversees data quality including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations, and suspected serious non-compliance by sites * Oversees and ensures the CROs and Third Party Vendors are in alignment and are delivering per the scope of work * Ensure clinical project audit and inspection readiness through the study lifecycle * Supports internal audit and external inspection activities and contributes to CAPAs as required * Manages and oversees study close-out activities including but not limited to database lock, reconciliation of vendor contracts, budget, TMF, and study drug accountability * Contributes to clinical study report writing and review * Facilitates and contributes to study level lessons learned * Assigns tasks to Clinical Study Management staff and supports their deliverables * Recommends and participates in cross-functional and departmental process improvement initiatives * Responsible for identification of innovative approaches to clinical study execution including global considerations and continuous improvement of CTM SOPs * May be assigned unmasked tasks for studies, which may include but is not limited to, assisting with masked investigational product, set up and management of unmasked trial master file, review of unmasked data in the electronic data capture system, point of contact for IVRS issues, and support oversight of unmasked clinical monitoring * Responsible for direct supervision of CTM staff. Line management responsibilities include work assignments, performance management, staff recruitment, professional development, coaching, mentoring, ongoing training and compliance, and study support/oversight * May require 25% travel This role may be for you if you have: * Exceptional interpersonal & leadership skills * Applies advanced expertise and implements the operational strategic direction and guidance for respective clinical studies * Demonstrates expert knowledge and a data driven approach to planning, executing, and problem solving * Advanced communication skills via verbal, written and presentation abilities * Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization * Ability to influence and negotiate across a wide range of stakeholders * Strong budget management experience * An awareness of relevant industry trends * Ability to build, lead and develop productive study teams and collaborations * Applies advanced negotiation and interpersonal skills to vendor management * Advanced technical proficiency in trial management systems and MS applications including (but not limited to) Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC * Extensive experience in global clinical trial operations with unique knowledge and skills to contribute to the development of protocols and key study documents * Knowledge of ICH/GCP and regulatory guidelines/directives * Advanced project management skills, cross-functional team leadership and organizational skills * Line management experience In order to be considered qualified, a minimum of a Bachelor's degree is required and a minimum of 8 years relevant clinical trial experience. Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels! Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
    $133k-175k yearly est. Auto-Apply 60d+ ago
  • Sr Mgr. Regulatory Affairs

    Regeneron Pharmaceuticals 4.9company rating

    Uxbridge, MA jobs

    We are Regeneron, a leading science-based biopharmaceutical company dedicated to transforming lives through ground-breaking medicines. Our mission is to address high unmet medical needs across a range of therapeutic areas, including ophthalmology, oncology, cardiovascular, allergic, inflammatory, infectious, and rare diseases. As a Senior Manager, Regulatory Affairs (EU), you will play a meaningful role in crafting the future of global healthcare by driving regulatory strategies and ensuring compliance for our innovative development programs in metabolism and ophthalmology. This is your chance to create a meaningful impact on patients' lives while collaborating with a team of elite scientists and regulatory professionals. In a typical day you will: * Develop and implement regulatory strategies for assigned programs in collaboration with global development teams. * Lead the preparation and submission of Clinical Trial Applications (CTAs) via the Clinical Trials Information System (CTIS) to multiple EU member states. * Lead regulatory activities such as CTA amendments, annual reports, and other key submissions. * Conduct critical analyses of clinical and preclinical data, providing interpretations and conclusions to guide decision-making. * Review clinical protocols and study reports to ensure alignment with EU regulatory requirements. * Lead the preparation and execution of EU Scientific Advice requests, including meetings with the European Medicines Agency (EMA) and other national agencies. * Stay ahead of the curve by monitoring and interpreting new EU Commission and EMA guidelines, and provide training to scientific staff as needed. * Represent Regeneron in interactions with external stakeholders, including EMA scientific committees, EU national agencies, and industry associations. This role may be for you if you: * Thrive on developing and implementing regulatory strategies that drive innovation and compliance. * Have a proven track record navigating the complexities of EU regulatory requirements, including Clinical Trial Applications and interactions with the EMA. * Are passionate about advancing groundbreaking treatments in metabolism and ophthalmology. * Excel in establishing relationships and influencing collaborators across diverse teams. * Are diligent, with a talent for analyzing data and crafting clear, concise regulatory documents. * Enjoy collaborating with multidisciplinary teams to solve challenges and achieve shared goals. * Are proactive in staying informed about emerging regulatory trends and guidelines. To Be Considered: You must have a minimum of 4+ years of regulatory experience focused on supporting products through clinical development. An advanced degree in a scientific field is required, and experience with the EMA (e.g., scientific advice, orphan designation, Pediatric Investigation Plans) is highly preferred. A consistent record of supporting EU Clinical Trial Applications through approval and study start-up is crucial. Preferred qualifications include experience in regulatory strategy for metabolism or ophthalmology programs, as well as marketing authorization applications or lifecycle management of approved products via the centralized procedure. Strong written and verbal communication skills, along with the ability to negotiate and clearly articulate positions to partners, are critical for success in this role. Join us in shaping the future of medicine while advancing your career in a dynamic, collaborative, and inclusive environment. Together, we can make a difference. Apply today to be part of our mission to transform lives. Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit ********************************************************************* For other countries' specific benefits, please speak to your recruiter. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron's roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's on-site policy and expectations for your role and your location. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
    $133k-175k yearly est. Auto-Apply 25d ago
  • Senior Manager Clinical Study Lead (Asthma/Allergy)

    Regeneron Pharmaceuticals 4.9company rating

    Uxbridge, MA jobs

    The Senior Clinical Study Lead (CSL) is expected to operate with high-degree of independence and is accountable for the global execution of assigned large and/or complex clinical trials from study design, through execution, to study close out. The Senior CSL is accountable for the study timelines, study budget, and ensuring study conduct is in accordance with Regeneron Standard Operating Procedures (SOPs) and ICH/GCP. This role applies to internally sourced studies and studies out-sourced to Clinical Research Organizations (CROs) and the balance of direct leadership versus oversight will vary accordingly. Contributes and drives ongoing process improvement initiatives. This role is not eligible fully remote. This role is required to be onsite in one of our locations. A typical day in this role looks like: * Leads the cross-functional study team responsible for clinical study delivery and is the primary point of contact of leadership and oversight (as required) for the assigned study * Provides operational input into protocol development * Oversees and provides input to the development of study specific documentation including but not limited to: case report forms (CRF), data management plan, monitoring plan, monitoring oversight plan, project specific training plan, data review plan, statistical analysis plan, etc. * Oversees set-up and maintenance of study systems including but not limited to Clinical Trial Management System (CTMS), Trial Master File (TMF) etc. * Ensures compliance with the clinical trial registry requirements * Identifies outsourcing needs of the study and leads and oversees engagement, contracting and management of required vendors * Provides input into baseline budget development and management * Provides input into baseline timeline development and management * Leads risk assessment and identifies risk mitigation strategies at the study level * Leads the feasibility assessment to select relevant regions and countries for the study * Oversees/conducts site evaluation and selection * Leads investigator meeting preparation and execution * Monitors progress for site activation and monitoring visits and acts on any deviations from plan * Leads the development of and oversees implementation of patient recruitment and retention strategies and acts on any deviations from plan * Monitors data entry and query resolution and acts on any deviations from agreed metrics * Ensures accurate budget management and scope changes for internal and external studies * Oversees and provides input to the study drug and clinical supplies forecasting, drug accountability and drug reconciliation * Escalates issues related to study conduct, quality, timelines or budget to Program Operations Leader (POL) and other stakeholders and develops and implements appropriate actions to address issues * Oversees the execution of the clinical study against planned timelines, deliverables and budget * Oversees data quality including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations, and suspected serious non-compliance by sites * Oversees and ensures the CROs and Third Party Vendors are in alignment and are delivering per the scope of work * Ensure clinical project audit and inspection readiness through the study lifecycle * Supports internal audit and external inspection activities and contributes to CAPAs as required * Manages and oversees study close-out activities including but not limited to database lock, reconciliation of vendor contracts, budget, TMF, and study drug accountability * Contributes to clinical study report writing and review * Facilitates and contributes to study level lessons learned * Assigns tasks to Clinical Study Management staff and supports their deliverables * Recommends and participates in cross-functional and departmental process improvement initiatives * Responsible for identification of innovative approaches to clinical study execution including global considerations and continuous improvement of CTM SOPs * May be assigned unmasked tasks for studies, which may include but is not limited to, assisting with masked investigational product, set up and management of unmasked trial master file, review of unmasked data in the electronic data capture system, point of contact for IVRS issues, and support oversight of unmasked clinical monitoring * Responsible for direct supervision of CTM staff. Line management responsibilities include work assignments, performance management, staff recruitment, professional development, coaching, mentoring, ongoing training and compliance, and study support/oversight * May require 25% travel This role may be for you if you have: * Exceptional interpersonal & leadership skills * Applies advanced expertise and implements the operational strategic direction and guidance for respective clinical studies * Demonstrates expert knowledge and a data driven approach to planning, executing, and problem solving * Advanced communication skills via verbal, written and presentation abilities * Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization * Ability to influence and negotiate across a wide range of stakeholders * Strong budget management experience * An awareness of relevant industry trends * Ability to build, lead and develop productive study teams and collaborations * Applies advanced negotiation and interpersonal skills to vendor management * Advanced technical proficiency in trial management systems and MS applications including (but not limited to) Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC * Extensive experience in global clinical trial operations with unique knowledge and skills to contribute to the development of protocols and key study documents * Knowledge of ICH/GCP and regulatory guidelines/directives * Advanced project management skills, cross-functional team leadership and organizational skills * Line management experience In order to be considered qualified, a minimum of a Bachelor's degree is required and a minimum of 8 years relevant clinical trial experience. Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels! Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. Salary Range (annually) $0.00 - $0.00
    $133k-175k yearly est. Auto-Apply 60d+ ago
  • Director, R&D Team Effectiveness Center of Excellence

    Johnson & Johnson 4.7company rating

    Cambridge, MA jobs

    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: Human Resources Job Sub Function: Learning & Instructional Design Job Category: Professional All Job Posting Locations: Cambridge, Massachusetts, United States of America, La Jolla, California, United States of America, Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America Job Description: We are searching for the best talent for our Director - R&D Team Effectiveness Center of Excellence position, to be located in Raritan, NJ; Titusville, NJ; Spring House, PA; Cambridge, MA; or La Jolla, CA. 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 Purpose: The Director for the Team Effectiveness Center of Excellence inside Innovative Medicine R&D is part of the Strategy, Portfolio, & Operations organization (SP&O). This role is an active leader in achieving the outcomes for SP&O's Learning, Development, and Change Readiness strategic pillar: adaptable and empowered R&D teams and team systems, building individual capabilities to enable performance and development, and successful implementation and adoption of R&D transformation. This role will be responsible for building team-level capabilities and leading the design, development, and implementation of comprehensive team development strategies that enhance team capabilities, team effectiveness, and team performance across Innovative Medicine R&D. This role provides strategic leadership and oversight for the Team Effectiveness Center of Expertise inside Innovative Medicine R&D, ensuring alignment with R&D Goals & Objectives and driving excellence in operating model design, governance, and capability building. This role aligns team effectiveness approaches across several team and teaming constructs across J&J, Innovative Medicine, and R&D, and applies external research and evidence-based practices on team effectiveness and development. This role drives adaptive teaming best practices across the organization, and leads the continuous evolution of team practices to support changes in drug development This role publicizes best practices, use cases & learnings across the various organizations & communities, and disseminates teaming practices owned by the CoE. This position will have accountability for the measurement of progress, outcomes & business impacts from teaming solutions and initiatives, as well as govern teaming standards & practices. You will be responsible for: * Strategy Development: Design and implement innovative teaming strategies that align with R&D and organizational objectives. Partners with leaders in R&D and governance committees to gain sponsorship and momentum for these strategies. * Team Capability Program Management: Oversee the development, delivery, and evaluation of teaming programs to capabilities across R&D and IM Teaming ecosystems. * Needs Assessment: Conduct regular assessments to identify needs and gaps in critical teams or teaming systems, ensuring solutions are adaptable and scalable to address these needs * Partnerships: Establish partnerships with internal organizations supporting Learning & Development work across R&D, GCSO, HR, and Global Talent Management. * Metrics and Analysis: Develop and implement metrics and dashboards to measure the effectiveness of teaming programs and overall impact on R&D performance * Collaboration: Partner with senior leaders and HR teams to integrate teaming initiatives within major teaming systems and R&D talent and organizational strategies. Leads the R&D Teaming Community and aligns efforts across teaming practitioners in IM R&D * Leadership Development: Create and facilitate programs aimed at building leadership capabilities in the context of cross-functional and matrix teams. * People Leadership: Provide leadership and coaching to internal learning and development team (either JNJ or contractor colleagues), promoting a collaborative environment and high performance Qualifications / Requirements: * Bachelor's degree in Human Resources, Business Administration, Life Sciences, Learning & Development, Education, Psychology, Organizational Development, or a related field. Master's Degree preferred. * 10 years of progressive experience in Learning, Training, Organizational Design, Team Development, Organizational Development, Leadership Development, or Human Resources within the pharmaceutical or life sciences sector. * 5 years of people management experience. * Proven experience with programmatic approaches to develop intact teams, cohorts of teams, and teaming systems. * Expert facilitation skills with team-level interventions, with the adaptability to make agile shifts in-flight * Proven experience in performance consulting to identify gaps in teams and teaming systems, and and recommend solutions. * Strong knowledge of adult learning principles, instructional design, learning technologies and methodologies, and program evaluation. * Integrates change readiness principles to effectively identify key barriers and implement solutions to achieve change implementation and realization * Proven ability to manage multiple projects simultaneously and deliver on-time results. * Ability to analyze data to inform training strategies and improve program effectiveness. * Exceptional verbal and written communication skills, with the ability to present complex information clearly. * Strong interpersonal and persuasion skills that allow for effective collaboration with stakeholders at all levels 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: Adult Learning Theory, Assessment Models, Coaching, Cultural Competence, Facilitation, HR Strategic Management, Instructional Design, Instructional Development, Learning and Development (L&D), Learning Culture, Quality Assurance (QA), Reporting and Analysis, Tactical Planning, Talent Management, Technical Credibility, Training Delivery Methods, Training Needs Analysis (TNA) The anticipated base pay range for this position is : $150,000-$258,750 Additional Description for Pay Transparency: The expected base pay range for this position is $150,000-$258,750. 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. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis. Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation -120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year Holiday pay, including Floating Holidays -13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave - 10 days Volunteer Leave - 4 days Military Spouse Time-Off - 80 hours Additional information can be found through the link below. For additional general information on Company benefits, please go to: ********************************************* This job posting is anticipated to close on December 3, 2025. The Company may however extend this time-period, in which case the posting will remain available on *************************** to accept additional applications.
    $150k-258.8k yearly Auto-Apply 9d ago

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