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Confidential

Executive Director, Clinical Pharmacology

Confidential, Quincy, Massachusetts, us, 02169

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Executive Director, Clinical Pharmacology

About the Company

Respected biotechnology (BioTech) company developing innovative peptide-based therapies

Industry Biotechnology

Type Privately Held

About the Role

The Company is in search of a Senior Director of Clinical Pharmacology to provide strategic and scientific leadership in the development of clinical pharmacology plans. This pivotal role involves leading PK and PK/PD analyses and is instrumental in advancing the portfolio of therapies across all clinical development phases. The successful candidate will be the primary clinical pharmacology lead, ensuring the integration of modern principles into project plans and study design. Key responsibilities include developing and advising on study designs, crafting analysis plans, and translating data into insights that drive development decisions. The role also encompasses the generation of high-quality reports, contribution to regulatory documents, and fostering a culture of innovation and collaboration.

Candidates for this role at the company should hold an MS, PharmD, or PhD in a relevant field and have a minimum of 10 years' experience in designing and executing clinical development plans, with a preference for those experienced in peptide/protein. The ideal candidate will have a proven track record in preparing regulatory documents, engaging with regulatory agencies, and possess strong proficiency in PK/PD analyses and modeling. The role requires a detail-oriented leader with strong organizational skills, the ability to build strong relationships, and a commitment to high-quality work. The Senior Director will also be responsible for managing external clinical pharmacology vendors, presenting findings at scientific conferences, and contributing to the publication of research in peer-reviewed journals.

Hiring Manager Title Chief Medical Officer

Travel Percent Less than 10%

Functions

Medical Care/Hospital Administration Non-Profit Management