Overview The role is positioned in the Clinical Pharmacology group within the Clinical and Quantitative Pharmacology (CQP) function. The incumbent will partner with Pharmacometrics, Quantitative Systems Pharmacology, Translational Medicine, Clinical Development, and other cross‑functional teams to design and execute clinical pharmacology strategies that advance our mRNA platform and therapeutic pipeline. Here’s What You’ll Do Develop fit‑for‑purpose clinical pharmacology development plans, including dose selection and optimization, evaluation plans for special populations, PK/PD/immunogenicity assessment, and pediatric development. Collaborate with program teams to support dose selection strategy and decision‑making for first‑in‑human studies and IND submissions. Represent CQP in a highly matrixed setting to drive study execution and operational excellence toward product development goals. Lead the development of CQP sections in regulatory documents—clinical protocols, INDs, regulatory meeting briefing books, blA summary documents, and responses to regulatory authorities—and represent clinical pharmacology in regulatory interactions. Lead or oversee clinical pharmacology data analysis, interpretation, and reporting to inform clinical implications and development decisions. Advocate and showcase clinical pharmacology and MIDD strategies with internal and external stakeholders. Mentor junior team members and contribute to building a high‑performing Clinical Pharmacology team. Leverage literature data and collaborate with external consultants, CRO partners, and academic sites to solve clinical pharmacology challenges and expand organizational knowledge of the mRNA platform. Here’s What You’ll Need (Basic Qualifications) PhD and/or PharmD in Clinical Pharmacology, Pharmacometrics, Pharmaceutics, Statistics, Engineering, or a related field. Minimum 8–10 years of industry experience in clinical pharmacology. In‑depth knowledge of clinical pharmacology, PK/PD principles, modeling and simulation, ADME, and quantitative translational sciences. Hands‑on quantitative skills, modeling expertise, and familiarity with clinical operations and translational sciences. Sound knowledge of drug regulatory authority biopharmaceutics and clinical pharmacology requirements to support development and commercialization of new drug products. Drug development experience in oncology and rare diseases preferred; expertise in immune therapeutics and/or infectious diseases is a plus. Here’s What You’ll Bring to the Table (Preferred Qualifications) Platform expertise in mRNA therapeutics and/or experience with biologics and new modalities. Demonstrated ability to work independently, lead functional initiatives, adapt quickly, collaborate effectively, and influence cross‑functional teams. Proficiency with pharmacokinetic, modeling, and data visualization software (e.g., Phoenix WinNonlin, R, Monolix, NONMEM). Outstanding verbal and written communication skills, with the ability to distill complex data for diverse audiences. Track record of regulatory filings (NDA/BLA) and responding to regulatory agency questions, including knowledge of global regulatory requirements and guidance on quantitative analysis. Ability to develop and deliver clear, concise presentations for both internal and external meetings. Strong publication record. Effective teamwork, problem‑solving, and conflict‑resolution skills. Benefits Best‑in‑class healthcare coverage. Voluntary benefit programs supporting unique needs. Well‑being resources—including fitness, mindfulness, and mental health support. Family planning benefits (fertility, adoption, surrogacy). Generous paid time off: vacation, volunteer days, sabbatical, global recharge days, and discretionary year‑end shutdown. Savings and investment opportunities. Location‑specific perks and extras. Location Hybrid – Cambridge, Massachusetts Equal Employment Opportunity Moderna is a smoke‑free, alcohol‑free, and drug‑free work environment. Moderna is committed to equal employment opportunity and non‑discrimination for all employees and qualified applicants without regard to race, color, sex, gender identity, age, religion, national origin, ancestry, citizenship, ethnicity, disability, military status, genetic information, sexual orientation, marital or familial status, or any other characteristic protected under applicable law. Eligible applicants, including qualified individuals with criminal histories (consistent with legal requirements), are encouraged to apply. #J-18808-Ljbffr