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%.
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
Highly competitive and inclusive medical, dental and vision coverage options
Flexible Spending Accounts for medical expenses and dependent care expenses
Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
Family care benefits, including subsidized back-up care options and on-demand tutoring
Free premium access to fitness, nutrition, and mindfulness classes
Exclusive preferred pricing on Peloton fitness equipment
Adoption and family-planning benefits
Dedicated care coordination support for our LGBTQ+ community
Generous paid time off, including: • Vacation, sick time and holidays • Volunteer time to participate within your community • Discretionary year-end shutdown • Paid sabbatical after 5 years; every 3 years thereafter
Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
401k match and Financial Planning tools
Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
Complimentary concierge service including home services research, travel booking, and entertainment requests
Free parking or subsidized commuter passes
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 proud to be an equal opportunity workplace and is an affirmative action employer.
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 also consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to 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/AAP Employer)
