Senior Director, Clinical Pharmacology
Centessa Pharmaceuticals
August 13, 2026
Remote
United States
Clinical Research and Development
Key Responsibilities
- Lead strategy for collection and interpretation of information across in vitro, in vivo, literature, competitive sources, and clinical data to develop a translational knowledge base.
- Drive dose selection and optimization by integrating PK, PD, safety, efficacy, and CNS-specific biomarkers.
- Lead model-informed drug development (population PK, PK/PD, 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/neuroscience programs from first-in-human through registrational and post-marketing stages.
- Design, execute, and interpret clinical pharmacology studies (FIH, MAD, DDI, biopharmaceutics, patient studies).
- Serve as clinical pharmacology lead on program teams and trial working groups.
- Author and oversee clinical pharmacology sections of regulatory documents (INDs, CTAs, IBs, NDAs).
- Represent clinical pharmacology with FDA and other global health authorities to support dose justification and labeling.
- Partner with DMPK, Translational Sciences, Clinical Development, Biomarkers, Biostatistics, CMC, and Regulatory Affairs.
- Oversee CROs/external vendors for clinical pharmacology and modeling activities.
- Communicate and interpret results; contribute to portfolio strategy, prioritization, risk mitigation, and long-range planning.
- Serve as subject-matter expert; mentor/develop clinical pharmacology talent.
- Ensure submission-ready, high-quality documentation aligned with global regulatory standards.
Qualifications
- PhD, PharmD, or MD in Clinical Pharmacology, Pharmacokinetics, Pharmaceutical Sciences, or related.
- 8–12+ years biopharma clinical pharmacology experience with translational impact.
- Strong PK/PD, PK/PD integration, exposure–response, and DDI expertise.
- Experience developing/executing strategies across early-to-late stage (incl. registrational support).
- Demonstrated quantitative translational approaches (e.g., population PK, mechanistic PK/PD modeling) to inform CNS dose selection/optimization.
- Proficiency with NONMEM, R, Phoenix WinNonlin, SimCyp, or equivalent.
- Experience authoring regulatory clinical pharmacology components (IND/CTA/NDA) and engaging global authorities.
- Strong understanding of translational PK, CNS exposure considerations, and biomarker integration.
- Excellent communication, collaboration, and leadership in a fast-paced matrixed environment.
Compensation & Benefits
- Annual base salary range: $195,000–$275,000.
- Discretionary annual bonus; 401(k), medical/dental/vision/life insurance, paid time off, and health/wellness program.
Work Location
- Remote; occasional travel.
Position
- Full-Time, Exempt
- Lead strategy for collection and interpretation of information across in vitro, in vivo, literature, competitive sources, and clinical data to develop a translational knowledge base.
- Drive dose selection and optimization by integrating PK, PD, safety, efficacy, and CNS-specific biomarkers.
- Lead model-informed drug development (population PK, PK/PD, 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/neuroscience programs from first-in-human through registrational and post-marketing stages.
- Design, execute, and interpret clinical pharmacology studies (FIH, MAD, DDI, biopharmaceutics, patient studies).
- Serve as clinical pharmacology lead on program teams and trial working groups.
- Author and oversee clinical pharmacology sections of regulatory documents (INDs, CTAs, IBs, NDAs).
- Represent clinical pharmacology with FDA and other global health authorities to support dose justification and labeling.
- Partner with DMPK, Translational Sciences, Clinical Development, Biomarkers, Biostatistics, CMC, and Regulatory Affairs.
- Oversee CROs/external vendors for clinical pharmacology and modeling activities.
- Communicate and interpret results; contribute to portfolio strategy, prioritization, risk mitigation, and long-range planning.
- Serve as subject-matter expert; mentor/develop clinical pharmacology talent.
- Ensure submission-ready, high-quality documentation aligned with global regulatory standards.
Qualifications
- PhD, PharmD, or MD in Clinical Pharmacology, Pharmacokinetics, Pharmaceutical Sciences, or related.
- 8–12+ years biopharma clinical pharmacology experience with translational impact.
- Strong PK/PD, PK/PD integration, exposure–response, and DDI expertise.
- Experience developing/executing strategies across early-to-late stage (incl. registrational support).
- Demonstrated quantitative translational approaches (e.g., population PK, mechanistic PK/PD modeling) to inform CNS dose selection/optimization.
- Proficiency with NONMEM, R, Phoenix WinNonlin, SimCyp, or equivalent.
- Experience authoring regulatory clinical pharmacology components (IND/CTA/NDA) and engaging global authorities.
- Strong understanding of translational PK, CNS exposure considerations, and biomarker integration.
- Excellent communication, collaboration, and leadership in a fast-paced matrixed environment.
Compensation & Benefits
- Annual base salary range: $195,000–$275,000.
- Discretionary annual bonus; 401(k), medical/dental/vision/life insurance, paid time off, and health/wellness program.
Work Location
- Remote; occasional travel.
Position
- Full-Time, Exempt