Senior Medical Director, Clinical Development Endocrinology

About the role

Ascendis Pharma, a global biopharmaceutical company focused on Endocrinology, Rare Disease and Oncology, is hiring a Senior Medical Director for its clinical development team in endocrinology. The role leads the design, safety monitoring and data analysis of late-phase clinical trials and reports to the Vice President, Clinical Development, Endocrinology.

Key responsibilities

• Act as clinical lead of the therapeutic area, formulating and implementing the Clinical Development Plan and representing clinical development on the Project Core Team.
• Oversee clinical trial design, site and subject retention, and act as medical monitor, tracking safety and efficacy data in line with ICH GCPs and global SOPs.
• Lead teams of medical monitors and help complete trial documents such as protocols, investigator brochures, medical monitoring plans, site training materials, clinical study reports and health authority responses.
• Analyze, interpret and report clinical data, anticipate and solve complex drug development problems, and contribute to regulatory strategy.
• Draft and review clinical documents, manuscripts, presentations and regulatory submissions, and collaborate with clinical operations, statistics, regulatory affairs, medical affairs, HEOR, commercial and finance.
• Cultivate relationships with investigative sites, clinical consultants and key opinion leaders, and assist in portfolio management and commercial activities as needed.

Required profile

• M.D. degree.
• Completed accredited residency and fellowship (strongly preferred).
• At least 8 years of experience with clinical trial design and execution, and at least 10 years of industry experience; less experienced candidates may be considered for a Medical Director position.
• Board certification (strongly preferred), with a specialty in endocrinology or genetics highly desired.
• Excellent written and oral communication skills, ability to learn quickly, multi-task under pressure and handle confidential, regulated information with sound judgement.

What we offer

• Estimated salary of $315k-$345k depending on experience, qualifications and location.
• Possible discretionary annual bonus, stock-based long-term incentives and paid time off.
• 401(k) with company match, medical, dental and vision plans, life and AD&D insurance, disability benefits, pet and legal insurance, HSA and flexible spending accounts.
• Employee assistance program, professional development, mental health resources and paid leave for new parents.