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. The Clinical Development Medical Director will serve as the Medical Lead for Vertex clinical trials, working with cross-functional multidisciplinary study teams on clinical trial strategy, design and execution and serving as the Medical Monitor responsible for monitoring the safety of enrolled subjects on assigned trials. The incumbent will work on multiple trials in all Phases of clinical development, and may also participate in other selected projects in clinical development. Key Duties and Responsibilities: Leads the development of Study Protocols, Investigator Brochures, Clinical Development Plans and other key study 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 sections of INDs and CTAs, 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 (ICF), clinical research forms (CRF), statistical analysis plans (SAP), clinical pharmacology analysis plans (CPAP), and clinical study reports (CSR). Acts as liaison between Translational Medicine/Clinical Development and other internal groups at Vertex (e.g., Regulatory Affairs, Clinical Operations) for assigned studies Represents Vertex to outside medical personal in the development of clinical protocols and study conduct Performs other duties as assigned related to clinical programs Knowledge and Skills: Excellent oral and written communication skills Ability to work collaboratively in a fast-paced, team-based, matrix environment and to function independently as appropriate Effective at building alliances across functions, based on end-to-end drug development thinking and experience Board certification/eligibility in a medical, pediatric or surgical subspecialty Education and Experience: MD, DO or equivalent ex-US medical degree Board certification/eligibility in a specialty field is highly desired Typically requires 10 years of basic or clinical research experience in an academic or industrial setting, or the equivalent combination of education and experience Typically requires experience in analysis of research data and publications; working knowledge of biostatistics; working knowledge of GCP, scientific and clinical research methods and clinical study design Typically requires experience with design, execution, and analysis of clinical trials required 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, sickle cell disease, transfusion-dependent beta thalassemia,