EU remote
Senior Medical Director, Clinical Development Endocrinology - Job ID: 2048
About this role
Ascendis Pharma is a dynamic, fast-growing global biopharmaceutical company with locations in Denmark, Europe, and the United States. Today, we're advancing programs in Endocrinology Rare Disease and Oncology. Here at Ascendis, we pride ourselves on exceptional science, visionary leadership, and skilled and passionate colleagues. Guided by our core values of Patients, Science, and Passion, we use our TransCon® drug development platform to fulfill our mission of developing new and potentially best-in-class therapies to address unmet medical needs.
Our culture fosters a place where skilled, adaptable, and highly resourceful professionals can truly make their mark. We offer a dynamic workplace for employees to grow and develop their skills. The Senior Medical Director drives the design, safety monitoring, and data analysis of the Company’s late-phase clinical trials in endocrinology . As such, the Senior Medical Director is an important leader within the clinical development team.
The Senior Medical Director will report to the Vice President, Clinical Development, Endocrinology. Key Responsibilities As the clinical lead of a therapeutic area within endocrinology, responsible for the formulation and implementation of the Clinical Development Plan Represent clinical development on the Project Core Team Leverage medical expertise and hands-on clinical experience to promote relevance and rigor of the development program Provide leadership to study teams For clinical trials: design, provide overall oversight, and support site and subject retention Serve as a medical monitor for clinical trials, ensure study integrity, and track accumulating safety and efficacy data Provide leadership to teams of medical monitors: oversee all aspects of the clinical monitoring process in accordance with ICH GCPs and global SOPs to assess the safety and efficacy of investigational products Ensure successful completion of trial-related documents (including clinical trial protocols, investigator brochures, medical monitoring plans, site training materials, clinical study reports, health authority responses, standard operating procedures, etc.) with cross-functional team members Analyze, evaluate, interpret, and report clinical data Anticipate and solve complex drug development problems Contribute to regulatory strategy Contribute to drafting and reviewing of clinical documents, manuscripts, presentations, and regulatory submissions Maintain up-to-date knowledge of relevant science, medical information, good clinical practices, and regulatory guidance Collaborate with—and serve as a clinical research resource for—cross-functional colleagues (e.g.