Associate Medical Director, Endocrinology at Vertex Pharmaceuticals in Boston, MA

Job description

Job Description Vertex completed its acquisition of Crinetics Pharmaceuticals on September 1, adding commercial and pipeline endocrinology programs to Vertex’s innovation portfolio. The acquisition is expected to accelerate revenue growth and enhance the Company’s long-term earnings profile. The acquired portfolio includes PALSONIFY® (paltusotine), atumelnant, and several additional pipeline programs. PALSONIFY is the first and only once-daily oral therapy for acromegaly; it has launched in the United States, is approved in the European Union, and is under review by other global regulatory authorities. Atumelnant is an investigational, once-daily oral adrenocorticotropic hormone (ACTH) receptor antagonist in Phase 3 development for congenital adrenal hyperplasia (CAH) and Phase 2 development for Cushing’s syndrome. We are seeking a pediatric or adult endocrinologist to contribute clinical expertise to the development of atumelnant. General Summary: The Clinical Development Associate Medical Director will serve as the Medical Lead for clinical trials, working with cross-functional teams on trial strategy, design, execution, and reporting. In addition to oversight and accountability for the study as a whole, this role will serve as the internal primary Medical Monitor accountable for monitoring the safety of enrolled subjects and ensuring scientific integrity. The incumbent may participate in other projects to support the clinical development program. Key Duties and Responsibilities: Participates in the development of Study Protocols, Investigator's Brochures, Clinical Development Plans and other key documents in conjunction with other line functions and with minimal guidance Serves on cross-functional Study Execution Teams (SET) for assigned trials, working with other team members to achieve efficient, high-quality study execution Participates in the preparation of regulatory documents in support of regulatory submissions, including clinical section of INDs and CTAs, IND safety reports and annual reports for assigned trials, responses to regulatory authorities and Ethics Committees/IRBs, and other documents as appropriate Provides scientific and clinical input to study-related documents and analysis plans including informed consent forms, clinical research forms, statistical analysis plans, clinical pharmacology analysis plans, and clinical study reports Acts as liaison between Clinical Development and other internal groups at Vertex (e.g., Regulatory Affairs, Clinical Development Execution) for assigned studies Represents Vertex to outside medical personnel in the development of clinical protocols, in study conduct, and in external reporting of study results Performs other duties as assigned related to other aspects of Clinical Development Knowledge and Skills: Strong oral and written communication skills Ability to work collaboratively in a fast-paced, team-based matrix environment and to function independently as appropriate Global clinical research experience and experience interacting with regulatory authorities is a plus Working familiarity with analysis of research data, biostatistics, pharmacology and pharmacokinetics, international standards for Good Clinical Practice (GCP), clinical study design, ethics committee/Institutional Review Board review, preparation of manuscripts, abstract/posters, and oral presentations, overall drug/device clinical development Board certification/eligibility, as well as clinical training in a relevant medical specialty is highly desired Education and Experience: MD, DO or equivalent ex-US medical degree Typically requires 8 years of basic or clinical research experience in an academic or industry setting, or the equivalent combination of education and experience About Vertex Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases and conditions. The company has approved therapies for cystic fibrosis