Medical Director, Clinical Development, Endocrine & Rare Diseases - Job ID: 1442

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 Medical Director is involved in the design, safety monitoring, and data analysis of the Company’s late-phase clinical trials in endocrinology. As such, the Medical Director is an important and visible member of the clinical development team. The Medical Director position is based in the United States (preferably in Palo Alto, California) and will report to the Vice President, Clinical Development.

Key Responsibilities

• Contribute to formulation and implementation of the Clinical Development Plan

• Leverage medical expertise and hands-on clinical experience to promote relevance and rigor of the development program

• 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

• Provide leadership to study teams

• 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

• Ensure study integrity, and track accumulating safety and efficacy data

• 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. in clinical operations, statistics, regulatory affairs, medical affairs, health economics outcomes research, commercial, finance) to optimize product development

• Contribute to (and may be asked to represent the clinical development department in) corporate strategic and organizational initiatives

• Cultivate relationships with investigative sites, clinical consultants, and key opinion leaders to represent the interests of the company

• Assist in portfolio management and commercial activities as needed

• Complete assigned tasks thoroughly, accurately, and on time

• Adhere to rigorous ethical standards

• Travel up to 20% domestically and internationally for scientific meetings