Senior Director, Clinical Pharmacology
Centessa Pharmaceuticals · Massachusetts, United States · 3 wk ago
RemoteRemoteAnalyst$270k–$295k/yrFull-time
Key Responsibilities
- 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
- 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
- Audit and guide strategies for CNS exposure, brain penetration, target engagement, and translational biomarkers
- 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
- 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 clinical drug development
- Extensive experience developing and executing clinical pharmacology strategies for early-through late-stage programs, including registrational support
- Strong expertise in PK, PD, PK/PD integration, exposure-response analyses, and drug-drug interaction assessment
- Demonstrated experience applying quantitative clinical pharmacology 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
Compensation
The annual base salary range for this position is $270,000.00 to $295,000.00. Individual compensation within this range will be determined based on a variety of factors, including qualifications, skills, relevant experience, and job knowledge. In addition to base pay, this role is eligible for a discretionary annual bonus.
Benefits
Centessa also offers a comprehensive benefits package, which includes a 401(k) plan, company-sponsored medical, dental, vision, and life insurance, generous paid time off, and a health and wellness program.
Work Location
The Senior Director, Clinical Pharmacology role is a remote role based in the US, with occasional travel.