Our client is a clinical-stage biotechnology company is seeking a hands-on, execution-driven Head of Clinical Pharmacology to lead the design, analysis, and interpretation of clinical pharmacology strategies across multiple development programs in oncology and immunology.

This role is ideal for a scientific leader who thrives in a data-centric environment and enjoys working directly with PK/PD analyses, exposure-response modeling, and regulatory deliverables. The position combines strategic ownership with strong executional accountability, ensuring scientific rigor, internal alignment, and high-quality pharmacology outputs from IND through early clinical development.

Key Responsibilities:

Clinical Pharmacology Leadership & Strategy

• Serve as Clinical Pharmacology Lead and subject matter expert across multiple programs.
• Own the design and execution of clinical pharmacology plans from IND through early clinical development and proof-of-concept.
• Provide strategic input into dose selection, study design, and benefit–risk assessment.

PK/PD & Modeling Oversight

• Design and oversee PK, PD, and exposure-response analyses.
• Lead development of population PK and exposure-response modeling strategies in collaboration with Biometrics and external modeling partners.
• Ensure high-quality data interpretation to support internal decision-making.

Study Design & Execution

• Propose and oversee clinical pharmacology components of clinical trials, including:
• Food effect studies
• Drug–drug interaction studies
• Organ impairment assessments
• QT/QTc evaluations
• Support healthy volunteer and early-phase study design and execution.

Regulatory & Documentation

• Author and review clinical pharmacology sections of regulatory documents (e.g., INDs, NDAs, briefing books).
• Support regulatory interactions and health authority engagement.
• Ensure scientific rigor and consistency across submissions.

Cross-Functional Integration

• Partner closely with Translational Medicine and Biomarker teams to integrate mechanistic and biomarker data into PK/PD interpretation.
• Contribute to broader program planning, risk assessment, and prioritization based on pharmacologic insights.

Qualifications

• MD, PharmD, PhD, or equivalent in Clinical Pharmacology, Pharmaceutical Sciences, or related field.
• 12+ years of experience in Clinical Pharmacology and/or Pharmacometrics within biotech or pharma.
• Direct experience designing and executing early-phase clinical studies, including healthy volunteer trials.
• Strong expertise in PK analysis and exposure-response interpretation.
• Experience in oncology and/or immunology preferred.
• Experience managing external Clinical Pharmacology vendors or modeling partners.
• Demonstrated regulatory submission experience and health authority interaction.
• Strong communication skills and ability to operate effectively in a fast-paced, matrixed environment.