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Senior Director, Clinical Pharmacology jobs in United States
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Centessa Pharmaceuticals · 3 months ago

Senior Director, Clinical Pharmacology

Centessa Pharmaceuticals plc is a new kind of pharmaceutical company with a focus on data-driven decision making. They are seeking an experienced Senior Director, Clinical Pharmacology to provide scientific and strategic leadership for clinical pharmacology across a diverse pipeline, particularly in neuroscience drug development.
BiotechnologyLife SciencePharmaceuticalClinical Trials
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H1B Sponsor Likelynote

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
Assess 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
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

Qualification

Clinical PharmacologyPharmacokinetics (PK)Pharmacodynamics (PD)PK/PD IntegrationExposure–Response AnalysisDrug–Drug Interaction AssessmentQuantitative Clinical PharmacologyPopulation PK ModelingMechanistic PK/PD ModelingCNS Drug DevelopmentBiomarker IntegrationRegulatory Submission AuthoringClinical Pharmacology Tools - NONMEMClinical Pharmacology Tools - RClinical Pharmacology Tools - Phoenix WinNonlinClinical Pharmacology Tools - SimCyp

Required

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

Benefits

Discretionary annual bonus
Participation in our equity program
401(k) plan
Company-sponsored medical, dental, vision, and life insurance
Generous paid time off
Health and wellness program

Company

Centessa Pharmaceuticals

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Centessa Pharmaceuticals is a pharmaceutical company that focuses on drug development to address significant medical needs.

H1B Sponsorship

Centessa Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
50%
Represents job field similar to this job
Engineering and Development
Management and Executive
Trends of Total Sponsorships
*2025 (1)
2024 (1)

Funding

Current Stage
Public Company
Total Funding
$1.12B
Key Investors
Oberland CapitalGeneral Atlantic,Janus Henderson Investors,Vida Ventures
2026-03-31Acquired
2025-11-11Post Ipo Equity· $250M
2024-09-11Post Ipo Equity· $225M

Leadership Team

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John Crowley
Chief Financial Officer
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Gregory Weinhoff
Chief Business Officer
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Company data provided by crunchbase