Senior Director, Head of Clinical Pharmacology

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.

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