- Provide scientific and strategic leadership for translational clinical pharmacology across a diverse pipeline spanning early development through late-stage and registrational programs
- Develop and execute clinical pharmacology strategies addressing CNS exposure, dose optimization, and translational relevance
- Partner with cross-functional and cross-program teams to improve translational understanding and apply it to development programs
- Represent clinical pharmacology in regulatory interactions
- Lead collection and interpretation of in vitro, in vivo, literature, competitive-source, and clinical data
- 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
- Assess and guide CNS exposure, brain penetration, target engagement, and translational biomarker strategies
- 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 clinical pharmacology lead on program teams, clinical sub-teams, and trial working groups
- Author and oversee clinical pharmacology sections of regulatory documents, including INDs, CTAs, IBs, and NDAs
- Represent clinical pharmacology in interactions with FDA and other global health authorities
- Partner with DMPK, Translational Sciences, Clinical Development, Biomarkers, Biostatistics, CMC, and Regulatory Affairs
- Oversee CROs and external vendors conducting clinical pharmacology and modeling activities
- Communicate and interpret clinical pharmacology results to internal stakeholders
- Contribute to portfolio strategy, program prioritization, risk mitigation, and long-range clinical development planning
- Serve as a subject-matter expert on clinical pharmacology
- Mentor and develop clinical pharmacology talent
- Ensure high-quality, submission-ready documentation aligned with global regulatory standards
Requirements
- 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, such as population PK and 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, including INDs, CTAs, and 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
- Role is based in the US
Core Competencies
Demonstrates expertise in clinical pharmacology with a focus on CNS drug development, including dose optimization, translational strategies, and regulatory interactions. Proficient in leading clinical pharmacology studies and integrating pharmacokinetic and pharmacodynamic data to inform drug development decisions.
Highest-signal resume keywords
- PhD, PharmD, Or MD In Clinical Pharmacology
- 10+ Years Of Experience In Clinical Pharmacology
- Strong Expertise In PK, PD, And PK/PD Integration
- Proficiency With NONMEM, R, Phoenix WinNonlin, SimCyp
- Experience Authoring Regulatory Submissions
ATS Optimization Keywords
Hard Skills
- Clinical Pharmacology Strategy Development
- Dose Optimization
- Translational Science
- Population PK Modeling
- Mechanistic PK/PD Modeling
- Exposure-Response Analysis
- Drug-Drug Interaction Assessment
- Biomarker Integration
- Clinical Study Design
- Regulatory Documentation
Soft Skills
- Excellent Communication
- Collaboration Skills
- Leadership Skills
Industry Keywords
- CNS Drug Development
- Translational Pharmacology
- Biopharma
- Regulatory Interactions
- Clinical Pharmacology
Tools & Technologies
- NONMEM
- R
- Phoenix WinNonlin
- SimCyp
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Senior Director, Clinical Pharmacology/Translational Arbeitgeber: Jobtailor
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