Description of RoleCentessa is seeking an experienced Senior Director, Clinical Pharmacology 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
- 10+ 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
Work Location The Senior Director, Clinical Pharmacology role is based in the US, with occasional travel.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$177,000 - $338,800
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
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