Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company
Senior Director, Clinical Pharmacology
Boston, MA · Director · Full-time
Sponsorship not specified$275k-$295kDetected 6 days ago
PharmacologyFDA RegulatoryLeadershipCommunicationCollaborationBiostatisticsRegulatory Affairs
About the role
- Work Location The Senior Director, Clinical Pharmacology role is based in the US, with occasional travel.
- We will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
- Please note: We will not assign referral rights for any unsolicited resumes from recruitment agencies.
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 using integration of 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
- 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)
- Partner closely with DMPK, Translational Sciences, Clinical Development, Biomarkers, Biostatistics, CMC, and Regulatory Affairs
- Mentor and develop clinical pharmacology talent as the pipeline and organization grow
Requirements
- 12+ years of experience in clinical pharmacology within biopharma, with demonstrated impact in clinical drug development
- Strong expertise in PK, PD, PK/PD integration, exposure-response analyses, and drug-drug interaction assessment
- Proficiency with clinical pharmacology tools and platforms such as NONMEM, R, Phoenix WinNonlin, SimCyp, or equivalent
- 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
- PharmD or a PhD in Clinical Pharmacology, Pharmacokinetics, Pharmaceutical Sciences, or a related discipline
- Extensive experience developing and executing clinical pharmacology strategies for early‑ through late‑stage programs, including registrational support
- Demonstrated experience applying quantitative clinical pharmacology approaches (e.g., population PK, mechanistic PK/PD modeling) to inform CNS dose selection and optimization
- Experience authoring and delivering clinical pharmacology components of regulatory submissions (e.g., INDs, CTAs, NDAs) and interacting with global health authorities
Compensation
- The annual base salary range for this position is $275,000.00 to $295,000.00.
- Individual compensation within this range will be determined based on a variety of factors, including qualifications, skills, relevant experience, job knowledge location.
- In addition to base pay, this role is eligible for a discretionary annual bonus.
Benefits
- Represent clinical pharmacology in interactions with FDA and other global health authorities, supporting dose justification and labeling discussions
Company info
- Centessa Pharmaceuticals, a wholly owned subdisary of Eli Lilly and Company believes in a diverse environment and is committed to equal employment opportunity for all its employees and qualified applicants.
- We do not discriminate in recruitment, hiring, training, promotion, or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
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