[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.ResponsibilitiesLead clinical pharmacology strategy for CNS and neuroscience programs from first‑in‑human through registrational and post‑marketing stagesDesign, execute, and interpret clinical pharmacology studies, including FIH, multiple‑ascending dose, DDI, biopharmaceutics, and patient studiesDrive dose selection and optimization by integrating PK, PD, safety, efficacy, and CNS‑specific biomarkersLead model‑informed drug development, including population PK, PK/PD, and exposure–response analyses relevant to CNS targets and clinical safetyAssess and guide strategies for CNS exposure, brain penetration, target engagement, and translational biomarkersServe as the clinical pharmacology lead on program teams, clinical sub‑teams, and trial working groupsAuthor 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 discussionsPartner closely with DMPK, Translational Sciences, Clinical Development, Biomarkers, Biostatistics, CMC, and Regulatory AffairsOversee CROs and external vendors conducting clinical pharmacology and modeling activitiesEnsure timely communication and clear interpretation of clinical pharmacology results to internal stakeholdersContribute to portfolio strategy, program prioritization, risk mitigation, and long‑range clinical development planning for CNS assetsServe as a subject‑matter expert on clinical pharmacologyMentor and develop clinical pharmacology talent as the pipeline and organization growEnsure high‑quality, submission‑ready documentation aligned with global regulatory standardsSkillsPhD, PharmD, or MD in Clinical Pharmacology, Pharmacokinetics, Pharmaceutical Sciences, or a related discipline8–12+ years of experience in clinical pharmacology within biopharma, with demonstrated impact in clinical drug developmentExtensive experience developing and executing clinical pharmacology strategies for early‑ through late‑stage programs, including registrational supportStrong expertise in PK, PD, PK/PD integration, exposure–response analyses, and drug–drug interaction assessmentDemonstrated experience applying quantitative clinical pharmacology approaches (e.g., population PK, mechanistic PK/PD modeling) to inform CNS dose selection and optimizationProficiency with clinical pharmacology tools and platforms such as NONMEM, R, Phoenix WinNonlin, SimCyp, or equivalentExperience authoring and delivering clinical pharmacology components of regulatory submissions (e.g., INDs, CTAs, NDAs) and interacting with global health authoritiesStrong understanding of translational PK, CNS exposure considerations, and biomarker integration in neuroscience drug developmentExcellent communication, collaboration, and leadership skills with the ability to operate effectively in a fast‑paced, matrixed environmentBenefitsDiscretionary annual bonus401(k) planCompany-sponsored medical, dental, vision, and life insuranceGenerous paid time offHealth and wellness programCompany OverviewCentessa Pharmaceuticals is a pharmaceutical company that focuses on drug development to address significant medical needs. It was founded in 2021, and is headquartered in Cambridge, Massachusetts, USA, with a workforce of 51-200 employees. Its website is https://www.centessa.com.Company H1B SponsorshipCentessa Pharmaceuticals has a track record of offering H1B sponsorships, with 1 in 2025, 1 in 2024. Please note that this does not guarantee sponsorship for this specific role.