Senior Director, Clinical Pharmacology
About The Position
Centessa Pharmaceuticals, a clinical-stage company focused on developing orexin receptor 2 (OX2R) agonists for narcolepsy and other sleep-wake disorders, is seeking an experienced Senior Director, Clinical Pharmacology (translational). This role will provide scientific and strategic leadership for translational clinical pharmacology across a diverse pipeline, from early to late-stage development. The position is responsible for developing and executing clinical pharmacology strategies tailored to neuroscience drug development challenges, including CNS exposure, dose optimization, and translational relevance. The Senior Director will collaborate with cross-functional and cross-program teams to enhance the translational understanding of assets and apply this knowledge to development programs. Additionally, they will represent clinical pharmacology in regulatory interactions to facilitate the efficient, data-driven advancement of therapies within the neuroscience portfolio.
Requirements
- 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 biomarker integration in neuroscience drug development
- Excellent communication, collaboration, and leadership skills with the ability to operate effectively in a fast‑paced, matrixed environment
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
Benefits
- 401(k) plan
- company-sponsored medical, dental, vision, and life insurance
- generous paid time off
- health and wellness program
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
