Senior Director, Clinical Pharmacology/Translational

This is a fully remote position, open to applicants in United States.

📋 Description

• Provide scientific and strategic leadership for translational clinical pharmacology across a varied pipeline from early development to late-stage and regulatory programs.

• Develop and implement clinical pharmacology strategies that focus on CNS exposure, dose optimization, and translational relevance.

• Lead the collection and analysis of in vitro, in vivo, literature, competitive-source, and clinical data to establish a translational knowledge base.

• Drive dose selection and optimization by integrating pharmacokinetics (PK), pharmacodynamics (PD), safety, efficacy, and CNS-specific biomarkers.

• Lead model-informed drug development, including population PK, PK/PD, and exposure–response analyses.

• Evaluate and guide strategies related to CNS exposure, brain penetration, target engagement, and translational biomarkers.

• Oversee clinical pharmacology strategy for CNS and neuroscience programs from first-in-human trials through regulatory and post-marketing phases.

• Design, execute, and interpret clinical pharmacology studies, including first-in-human, multiple-ascending dose, drug-drug interaction, 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, including INDs, CTAs, IBs, and NDAs.

• Represent clinical pharmacology in discussions with the FDA and other global health authorities.

• Collaborate with DMPK, Translational Sciences, Clinical Development, Biomarkers, Biostatistics, CMC, and Regulatory Affairs.

• Manage 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-term clinical development planning for CNS assets.

• Act as a subject-matter expert in clinical pharmacology.

• Mentor and cultivate clinical pharmacology talent.

• Ensure high-quality, submission-ready documentation that meets global regulatory standards.

⛳️ Requirements

• PhD, PharmD, or MD in Clinical Pharmacology, Pharmacokinetics, Pharmaceutical Sciences, or a related field.

• Over 10 years of experience in clinical pharmacology within the biopharma industry, with a proven impact in translational science during drug development.

• Strong expertise in PK, PD, PK/PD integration, exposure–response analyses, and drug–drug interaction assessments.

• Extensive experience in developing and executing clinical pharmacology strategies for early to late-stage programs, including regulatory support.

• Demonstrated experience in applying quantitative clinical pharmacology and translational methodologies, such as population PK and mechanistic PK/PD modeling, to guide CNS dose selection and optimization.

• Proficiency in clinical pharmacology tools and platforms, including NONMEM, R, Phoenix WinNonlin, SimCyp, or equivalent.

• Experience in authoring and presenting clinical pharmacology components of regulatory submissions, including INDs, CTAs, and NDAs, as well as 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, capable of effectively operating in a fast-paced, matrixed environment.

🏝️ Benefits

• Company bonus eligibility based partly on both company and individual performance.

• Eligibility for a pension plan.

• Vacation benefits.

• Eligibility for healthcare benefits.

• Flexible benefits package.

• Life insurance and death benefits.

• Time off and leave of absence benefits.

• Well-being benefits, including an employee assistance program, fitness benefits, and employee clubs and activities.