Director, Clinical Pharmacology

Role Summary

Director, Clinical Pharmacology at Harmony Biosciences in Plymouth Meeting, PA. This role serves as a key contributor to Harmony’s clinical development programs by supporting the strategic design, execution, and interpretation of clinical pharmacology studies that guide dose selection, exposure–response understanding, and overall clinical strategy. The position works closely with cross‑functional partners to develop study protocols, oversee PK/PD analyses, and ensure high‑quality data generation to support regulatory submissions and clinical decision‑making. Ideal candidates bring foundational experience in clinical studies or PK/PD analysis, strong analytical and communication skills, and a desire to grow within a dynamic, collaborative, and patient‑focused organization.

Responsibilities

• Lead clinical pharmacology and PK/PD strategy development across assigned programs and indications.
• Serve as the clinical pharmacology expert on cross‑functional program and governance teams, providing PK/PD guidance from early development through clinical stages.
• Provide scientific oversight for PK, PD, exposure–response, QT/QTc, DDI, special population studies, and modeling and simulation activities.
• Oversee CROs and internal partners to ensure high‑quality execution, analysis, and interpretation of clinical pharmacology studies in alignment with GCP and regulatory expectations.
• Contribute to protocol development, study execution, data analysis, study reports, and regulatory documentation.
• Prepare and review clinical pharmacology content for regulatory submissions (IND, NDA, briefing packages) and participate in Health Authority interactions.
• Maintain up‑to‑date knowledge of regulatory guidance, scientific advances, and industry best practices in clinical pharmacology and modeling/simulation.
• Collaborate closely with Clinical Development, Biostatistics, Regulatory Affairs, CMC, and Pharmacovigilance to integrate clinical pharmacology strategies.
• Ensure adherence to company SOPs, GCP, FDA/ICH guidelines, and applicable regulatory standards.

Qualifications

• PhD, PharmD, or MD required in Clinical Pharmacology, Pharmaceutical Sciences, Pharmacokinetics, or related discipline
• 8+ years of relevant industry experience in clinical pharmacology and/or pharmacometrics within a pharmaceutical or biotechnology R&D environment.
• Solid understanding of clinical pharmacology principles in drug development including PK/PD modeling and simulation, biopharmaceutics and ADME concepts and modeling required
• Familiarity with clinical trial design and regulatory requirements required
• Experience with NCA and PK/PD analysis modeling tools (ie. NONMEM, Phoenix WinNonlin, R) preferred
• Demonstrated leadership in clinical pharmacology strategy, regulatory interactions, and program‑level decision‑making.
• Proven ability to mentor others and influence cross‑functional stakeholders.
• Must think critically and creatively, and be able to determine appropriate resources for resolution of problems and have strong organizational and planning skills
• Solid working knowledge of FDA, ICH and CFR regulations and clinical pharmacology-related guidance documents
• Strong written and oral communication skills
• Excellent interpersonal and collaboration skills

Additional Requirements

• Travel (domestic and international) is estimated to be 10% of the time for this position; Candidate must be able to maintain or obtain valid US Passport within 90 days of hire date.
• Noise level in the work environment is usually quiet.
• Specific vision abilities required: Close vision.
• Manual dexterity to use computers, tablets, and cell phones.
• Continuous sitting for prolonged periods.