Description

Harmony Biosciences is recruiting for an Associate Director, Clinical Pharmacology. 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, exposureresponse understanding, and overall clinical strategy. This position works closely with crossfunctional partners to develop study protocols, oversee PK/PD analyses, and ensure highquality data generation to support regulatory submissions and clinical decisionmaking. Responsibilities include analyzing and summarizing PK/PD data, contributing to clinical study reports and regulatory documents, and staying current with scientific and regulatory developments in the field. 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 patientfocused organization.

Responsibilities include but are not limited to:

• Lead clinical pharmacology and PK/PD strategy development across assigned programs and indications.
• Serve as the clinical pharmacology expert on crossfunctional 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 highquality 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 uptodate 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.

Requirements

Qualifications:

• PhD, PharmD, or MD required in Clinical Pharmacology, Pharmaceutical Sciences, Pharmacokinetics, or related discipline
• 5+ years of relevant industry experience in clinical pharmacology and/or pharmacomerics 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 programlevel decisionmaking.
• Proven ability to mentor others and influence crossfunctional 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 document
• Strong written and oral communication skills
• Excellent interpersonal and collaboration skills
   

Physical demands and work environment:

• Travel (both 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.
• While performing the duties of this job, the noise level in the work environment is usually quiet.
• Specific vision abilities required by this job include: Close vision.
• Manual dexterity required to use computers, tablets, and cell phone.
• Continuous sitting for prolonged periods.