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Senior Director, Clinical Pharmacology

Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company · Boston, MA
Full-timeNon-ClinicalHealthcare$128,000–$173,000/yr
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About the Senior Director Clinical Pharmacology role

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Description of Role Centessa is seeking an experienced Senior Director, Clinical Pharmacology (translational) to provide scientific and strategic leadership for translational clinical pharmacology across a diverse pipeline spanning early development through late‑stage and registrational programs. Reporting to the Executive Director, Clinical Pharmacology, this position is accountable for developing and executing clinical pharmacology strategies that address the unique challenges of neuroscience drug development, including CNS exposure, dose optimization, and translational relevance. The Senior Director partners closely with cross‑functional teams, and cross-program teams to achieve broader translational understanding of our assets, and application of that knowledge to development programs. Additionally, they will represent clinical pharmacology in regulatory interactions to enable efficient, data‑driven advancement of therapies across our neuroscience portfolio. Key Responsibilities Lead strategy for collection and interpretation of information across in vitro, in vivo, literature of competitive sources, and clinical data to develop a translational knowledge base to Centessa assets Drive dose selection and optimization by integrating PK, PD, safety, efficacy, and CNS‑specific biomarkers Lead model‑informed drug development, including population PK, PK/PD, and exposure–response analyses relevant to CNS targets and clinical safety Assess and guide strategies for CNS exposure, brain penetration, target engagement, and translational biomarkers Lead clinical pharmacology strategy for CNS and neuroscience programs from first‑in‑human through registrational and post‑marketing stages Design, execute, and interpret clinical pharmacology studies, including FIH, multiple‑ascending dose, DDI, biopharmaceutics, and patient studies Serve as the clinical pharmacology lead on program teams, clinical sub‑teams, and trial working groups Author and oversee clinical pharmacology sections of regulatory documents (e.g., INDs, CTAs, IBs, NDAs) Represent clinical pharmacology in interactions with FDA and other global health authorities, supporting dose justification and labeling discussions Partner closely with DMPK, Translational Sciences, Clinical Development, Biomarkers, Biostatistics, CMC, and Regulatory Affairs Oversee CROs and external vendors conducting clinical pharmacology and modeling activities Ensure timely communication and clear interpretation of clinical pharmacology results to internal stakeholders Contribute to portfolio strategy, program prioritization, risk mitigation, and long‑range clinical development planning for CNS assets Serve as a subject‑matter expert on clinical pharmacology Mentor and develop clinical pharmacology talent as the pipeline and organization grow Ensure high‑quality, submission‑ready documentation aligned with global regulatory standards Qualifications PhD, PharmD, or MD in Clinical Pharmacology, Pharmacokinetics, Pharmaceutical Sciences, or a related discipline 8–12+ years of experience in clinical pharmacology within biopharma, with demonstrated impact in translational science in drug development Strong expertise in PK, PD, PK/PD integration, exposure–response analyses, and drug–drug interaction assessment Extensive experience developing and executing clinical pharmacology strategies for early‑ through late‑stage programs, including registrational support Demonstrated experience applying quantitative clinical pharmacology and translational approaches (e.g., population PK, mechanistic PK/PD modeling) to inform CNS dose selection and optimization Proficiency with clinical pharmacology tools and platforms such as NONMEM, R, Phoenix WinNonlin, SimCyp, or equivalent Experience authoring and delivering clinical pharmacology components of regulatory submissions (e.g., INDs, CTAs, NDAs) and interacting with global health authorities Strong understanding of translational PK, CNS exposure considerations, and biomark…

Salary estimate

$128,000 – $173,000/yr
Provided by the employer.

Skills for this role

CommunicationLeadership

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About Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company

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