Senior Director, Clinical Pharmacology
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AI Summary
Description of Role
Centessa is seeking an experienced Senior Director, Clinical Pharmacology (translational) to provide scientific and strategic leadership for translational clinical pharmacology across a diverse pipeline spanning early development through late‑stage and registrational programs. Reporting to the Executive Director, Clinical Pharmacology, this position is accountable for developing and executing clinical pharmacology strategies that address the unique challenges of neuroscience drug development, including CNS exposure, dose optimization, and translational relevance. The Senior Director partners closely with cross‑functional teams, and cross-program teams to achieve broader translational understanding of our assets, and application of that knowledge to development programs. Additionally, they will represent clinical pharmacology in regulatory interactions to enable efficient, data‑driven advancement of therapies across our neuroscience portfolio.
Key Responsibilities
- Lead strategy for collection and interpretation of information across in vitro, in vivo, literature of competitive sources, and clinical data to develop a translational knowledge base to Centessa assets
- 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
- 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
- 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
Qualifications
- 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 translational science in drug development
- Strong expertise in PK, PD, PK/PD integration, exposure–response analyses, and drug–drug interaction assessment
- Extensive experience developing and executing clinical pharmacology strategies for early‑ through late‑stage programs, including registrational support
- Demonstrated experience applying quantitative clinical pharmacology and translational 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
Compensation
The annual base salary range for this position is $195,000 to $275,000.00. Individual compensation within this range will be determined based on a variety of factors, including qualifications, skills, relevant experience, job knowledge and location.
In addition to base pay, this role is eligible for a discretionary annual bonus. The Company also offers a comprehensive benefits package, which includes a 401(k) plan, company-sponsored medical, dental, vision, and life insurance, generous paid time off, and a health and wellness program.
Work Location
The Senior Director, Clinical Pharmacology role is remote based, with occasional travel.
POSITION: Full-Time, Exempt
EEOC Statement: 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. 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.
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