Director, Clinical Pharmacology

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

📋 Description

• Lead the strategy for clinical pharmacology within one or more oncology programs, ensuring compliance with regulatory standards and scientific principles.

• Design and oversee clinical pharmacology studies that support the clinical development plans of assigned oncology programs.

• Collaborate with cross-functional teams, including clinical development, operations, biostatistics, and regulatory affairs, to propel drug development initiatives.

• Advocate for the application of model-informed drug development (MIDD) strategies, including population PK/PD and exposure–response analyses.

• Author relevant sections/modules of regulatory documents (such as INDs, IBs, CTAs, IMPDs, NDAs, briefing packages, or other regulatory dossiers) and act as a subject matter expert during regulatory discussions with the FDA and other global health authorities.

• Analyze and convey clinical pharmacology data and findings to internal teams, health authorities, and external stakeholders.

• Collaborate with biostatistics and data management to create analysis datasets, statistical analysis plans, and reporting standards for PK/PD endpoints.

• Contribute to dose selection and optimization of dosing regimens across programs by utilizing exposure–response relationships and emerging clinical data.

• Provide clinical pharmacology insights for study protocols, informed consent forms, and clinical study reports.

• Keep abreast of industry trends and advancements in clinical pharmacology and oncology, contributing to the scientific community through presentations and publications.

• Engage in cross-functional team meetings, sharing clinical pharmacology insights and updates with internal stakeholders.

⛳️ Requirements

• Ph.D. or equivalent in pharmacokinetics (PK)/pharmacodynamics (PD), Pharmacology, Chemistry, or a related discipline.

• A minimum of 8 years of experience in clinical pharmacology, especially with small molecule modalities in the oncology therapeutic area.

• A proven history of successfully managing clinical pharmacology studies and developing regulatory submissions.

• Strong comprehension of oncology drug development processes and regulatory guidelines, including those set by the FDA and global health authorities.

• Preferred quantitative pharmacology skillset, including PBPK, PK/PD modeling, population PK, and exposure–response analyses.

• Experience in authoring clinical pharmacology sections of regulatory dossiers (INDs, NDAs, CTAs, briefing packages).

• Excellent communication and interpersonal skills, with the ability to work effectively in a cross-functional team setting.

• Prior experience in a lean or startup environment is highly desirable.

🏝️ Benefits

• Annual bonus

• Stock-based long-term incentives

• Medical, dental, and vision benefits

• Retirement plan

• Wellness stipend

• Flexible time off