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 Clinical Pharmacology. This position is critical for leading and enhancing a high-performing Clinical Pharmacology team to meet the expanding needs of our organization. This individual will bring strong expertise in clinical pharmacology, Model-Informed Drug Development (MIDD), expertly representing CQP on program teams, and people leadership, contributing significantly to advancing our exciting mRNA platform and therapeutic pipeline.
The role is positioned within CQP in the Translational Medicine function within Moderna’s growing Therapeutics & Oncology development organization in R&D. Success in this role requires close collaboration with the Translational Medicine, Research (including Nonclinical Development), Clinical Development, Clinical Safety and Risk Management, and Regulatory functions and program teams to ensure integrated and innovative clinical pharmacology strategies are developed and executed to enable agile development of our exciting pipeline. This leader will oversee clinical pharmacology strategies across therapeutic areas, partnering closely with TM colleagues in Pharmacometrics and Quantitative Systems Pharmacology, from preclinical development through lifecycle management.
At Moderna, we are pioneering the development of mRNA medicines to transform patients' lives. As part of our innovative team, you will play a key role in shaping the future of medicine while growing your career in a supportive, collaborative environment.
Here’s What You’ll Do
Develop and implement robust clinical pharmacology strategies from pre-IND to lifecycle management.Ensure robust development and alignment of clinical pharmacology strategies with the therapeutic indication, patient population, and development phase.Advocate and represent clinical pharmacology and MIDD strategies with internal and external stakeholders.Provide deep scientific expertise in clinical pharmacology, PK/PD, and MIDD to:- Guide dose decisions from first-in-human (FIH) studies to submission and beyond.
- Develop the Clinical Pharmacology package, including dose selection, optimization, and immunogenicity assessments.
- Collaborate with cross-functional teams on MIDD strategies and data analyses.
- Contribute to the development of regulatory documents (e.g., clinical protocols, INDs, BLAs, responses to regulatory authorities) and represent clinical pharmacology in regulatory interactions.
- Elevate, mentor and develop a high-performing Clinical Pharmacology team.
- Build a culture of collaboration, innovation, and accountability within the team.
- Partner with Translational Medicine colleagues to integrate clinical pharmacology strategy into broader translational, platform, and clinical development strategies.
- Represent clinical pharmacology expertise in internal governance meetings to inform data-driven decisions.
- Foster collaboration across research, clinical development, and regulatory functions to drive innovative approaches in advancing Moderna’s mRNA platform.
Here’s What You’ll Bring To The Table
- PhD in Clinical Pharmacology, Pharmacometrics, Pharmaceutics, Statistics, Engineering, or a related field.
- Minimum of 10 years of pharmaceutical or biotech industry experience in clinical pharmacology.
- Proven track record of advancing programs from discovery through IND to registration.
- Therapeutic area expertise in oncology orrare diseases preferred; expertise in immune therapeutics and/or infectious diseases a plus.
- Platform expertise in mRNA therapeutics preferred. Expertise with additional therapeutic platforms would be a plus.
- Deep understanding of clinical pharmacology principles, including ADME, posology, and quantitative translational sciences.
- Demonstrated experience building, and leading high-performing teams, and a strong commitment to and track record in people development
- Ability to collaborate effectively in a highly matrixed environment and influence cross-functional teams.
- Maintain a strong external network of thought leaders in clinical pharmacology and pharmacometrics.
- Expertise in regulatory requirements and submissions across major regions.
- Familiarity with GXP-related quality requirements and experience with large molecules or new modalities.
- Outstanding verbal and written communication skills, with the ability to distill complex data for diverse audiences.
- Exceptional problem-solving and stakeholder management skills.
- Strong thought leadership in clinical pharmacology and visibility within the external scientific community.
- Hands-on modeling expertise and familiarity with translational sciences are a plus.
- This role is based in our new LEED-certified HQ in Cambridge, MA and is expected to be in office 70% of the time with flexibility to work from home up to 30%.
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 a suite of voluntary benefit programs to support your unique needs
- A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
- Lifestyle Spending Accounts to personalize your well-being journey
- Family planning and adoption benefits
- Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
- Savings and investment opportunities
- Location-specific perks and extras
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.
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.
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.
Moderna is a smoke-free, alcohol-free, and drug-free work environment.
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 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 an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements.
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. (EEO Employer)
