Senior Director, Clinical Pharmacology/Translational

Stellenbeschreibung:

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.