Senior Director – Clinical Pharmacology

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

📋 Description

• Lead the technical and operational functions of the Clinical Pharmacology department throughout preclinical and clinical development.

• Supervise clinical pharmacology and translational PK/PD operations and deliverables for infectious disease and oncology programs.

• Act as the clinical pharmacology and translational PK/PD technical authority on cross-functional project teams.

• Formulate clinical pharmacology strategies that support development and regulatory decisions from pre-IND to market authorization.

• Choose and implement PK/PD, PopPK, and exposure-response modeling and simulation methodologies for dose selection and optimization.

• Draft and provide technical input for regulatory documents, submissions, and responses.

• Collaborate with clinical research, clinical operations, biomarkers, bioanalytical, biometrics, CMC, research, and regulatory teams.

• Establish and oversee relationships with external vendors and collaborating partners.

• Generate and manage departmental budgets while optimizing resource allocation.

• Oversee, recruit, mentor, and develop the Clinical Pharmacology and Translational PK/PD team.

• Report directly to the VP of Translational Development.

⛳️ Requirements

• PhD, PharmD, or MD with relevant training in clinical pharmacology, pharmacokinetics, pharmaceutics, or a related field.

• Over 13 years of industry experience in Clinical Pharmacology, DMPK, and/or related areas.

• In-depth knowledge of nonclinical and clinical pharmacokinetic concepts and methodologies.

• Comprehensive understanding of the multidisciplinary requirements of drug development.

• Expertise in PK/PD, PopPK, and exposure-response modeling.

• Significant experience leading translational and clinical pharmacology efforts from candidate selection to market authorization.

• Strong grasp of regulatory requirements and experience in contributing to regulatory submissions and interactions.

• Working knowledge of bioanalytical techniques that support the clinical development of small molecules and biologics.

• Required experience with biologics, including monoclonal antibodies and bispecifics.

• Experience in oncology indications is highly preferred.

• Proficient in standard PK analysis and graphing software.

• Demonstrated ability to manage and develop teams.

• Must currently possess authorization to work for any employer in the U.S.; visa sponsorship is not available.

🏝️ Benefits

• Compensation, bonus, and equity.

• Health and welfare benefit plans.

• Non-accrual paid time off.

• Company shutdown for holidays.

• Commuter benefits.

• 401K match.

• Daily lunch provided in the office.