Senior Medical Director, Clinical Development Endocrinology - Job ID: 2048

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

Requirements

• M.D. degree
• Completion of an accredited residency and fellowship (strongly preferred)
• At least 8 years of experience with clinical trial design and execution
• Strong track record of scientific and clinical inquiry
• Board-certified (strongly preferred), with specialty in endocrinology or genetics highly desired
• At least 10 years of industry experience (other relevant experience e.g. post-graduate experience in the clinical and/or academic realms may also be considered on a case-by-case basis). Those with less experience may be considered for a Medical Director position.
• Possess excellent communication skills (written and oral)
• Learn quickly, follow complex directions under pressure
• Multi-task while remaining organized and attentive to detail
• Lead both directly and by example
• Work hard, be a trustworthy and collaborative team player
• Take initiative and solve complex problems
• Demonstrate sound judgement in terms of handling complex, confidential, and regulated information

The estimated salary range for this position is $315k-$345k DOE. Actual salary determination is dependent on a variety of factors some of which include: experience, qualifications, and geographic location. This position may be eligible for a discretionary annual bonus or an incentive compensation plan (eligibility varies based on role and position level), discretionary stock-based long-term incentives, paid time off, and a comprehensive benefits package.