Director, Clinical Pharmacology

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

📋 Description

• Provide leadership in clinical pharmacology and offer scientific insights to cross-functional development and study teams.

• Formulate and implement clinical pharmacology strategies that integrate nonclinical and clinical PK, PK/PD, exposure-response, safety, efficacy, and biomarker data.

• Guide study design, dose selection, and optimization processes.

• Design and supervise studies related to human ADME, DDI, food effects, bioavailability, and special populations.

• Conduct and/or manage non-compartmental PK analyses and interpret emerging clinical PK/PD data using standard industry software.

• Utilize and/or manage population PK, PK/PD, exposure-response, and PBPK modeling.

• Write and evaluate clinical pharmacology content for protocols, Investigator’s Brochures, INDs, IMPDs, briefing documents, clinical study reports, and other regulatory submissions.

• Assist in regulatory interactions as necessary.

• Select and manage CROs and external consultants, ensuring scientific integrity, adherence to timelines, and achievement of deliverables.

• Review emerging clinical data, recognize clinical pharmacology risks and opportunities, and convey findings and suggestions to cross-functional teams and senior leadership.

• Collaborate with Clinical Development, Clinical Operations, Biostatistics, Biomarkers, Bioanalytical, Nonclinical PK/PD, Toxicology, Regulatory Affairs, and other departments.

⛳️ Requirements

• PhD with 8+ years, or MS with 12+ years, of pertinent experience in the pharmaceutical or biotechnology industry focusing on clinical pharmacology and drug development.

• Extensive experience supporting early clinical development.

• Required experience with small-molecule drug development.

• Strong understanding of clinical pharmacology, ADME, PK, PK/PD, exposure-response, DDI, as well as dose selection and optimization.

• Proven ability to formulate clinical pharmacology strategies and incorporate emerging clinical data to guide study design and dose-selection decisions.

• Practical experience with noncompartmental PK analysis and interpretation of clinical PK/PD data.

• Familiarity with Phoenix WinNonlin and/or R is preferred.

• Knowledge of model-informed drug development and quantitative methodologies, including population PK, PK/PD, exposure-response, and PBPK modeling.

• Hands-on experience in modeling and simulation is advantageous.

• Experience in authoring and reviewing clinical pharmacology content for regulatory submissions and facilitating interactions with the FDA and other global regulatory bodies.

• Understanding of relevant FDA, EMA, and ICH guidelines is essential.

• Experience managing CROs, consultants, and other external collaborators.

• Strong scientific judgment, critical thinking, problem-solving, communication, and presentation capabilities.

• Ability to work autonomously and collaborate effectively across functions in a dynamic biotechnology environment.

• Successful completion of a background check is a requirement for employment.

🏝️ Benefits

• Benefits are included.

• A bonus may be provided.

• Equity may also be offered.