[Remote] Senior Director, Clinical Pharmacology

Note: The job is a remote job and is open to candidates in USA. Centessa Pharmaceuticals is a new kind of pharmaceutical company focused on data-driven decision making. They are seeking a Senior Director of Clinical Pharmacology to provide scientific and strategic leadership for clinical pharmacology across their neuroscience pipeline, ensuring efficient advancement of therapies through regulatory interactions and cross-functional collaboration.

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

Skills

• 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
• 401(k) plan
• Company-sponsored medical, dental, vision, and life insurance
• Generous paid time off
• Health and wellness program

Company Overview

Company H1B Sponsorship