Medical Director, Clinical Development

About the role

Ascendis Pharma, a global biopharmaceutical company focused on Endocrinology, Rare Disease and Oncology, is hiring a Medical Director for its Clinical Development function. The role is based in the United States and reports to the Vice President, Clinical Science. It covers the design, monitoring, data analysis and interpretation of late-phase clinical trials in endocrinology.

Key responsibilities

• Help formulate and implement the Clinical Development Plan and bring rigor to the development program
• Design, oversee and support clinical trials, including site and subject retention
• Serve as Medical Monitor, ensure study integrity and track safety and efficacy data
• Lead teams of medical monitors and study teams
• Ensure completion of trial documents such as protocols, investigator brochures, medical monitoring plans, site training materials, clinical study reports, health authority responses and SOPs
• Analyze, evaluate, interpret and report clinical data, and contribute to regulatory strategy
• Draft and review clinical documents, manuscripts, presentations and regulatory submissions
• Keep up to date with science, Good Clinical Practice and regulatory guidance
• Collaborate with clinical operations, statistics, regulatory affairs, medical affairs, HEOR, commercial and finance, and represent the clinical development department in corporate initiatives
• Cultivate relationships with sites, clinical consultants and key opinion leaders, and assist with portfolio management and commercial activities
• Travel up to 20% domestically and internationally for scientific meetings

Required profile

• M.D. degree
• ACGME-accredited residency and fellowship completed (strongly preferred)
• Physician licensure in at least one state (strongly preferred)
• Board certification (strongly preferred), with endocrinology specialty highly desired
• At least 5 years of industry experience; less experienced candidates may be considered for an Associate Medical Director position
• At least 3 years of experience with clinical trial design and execution

Required skills

• Excellent written and oral communication
• Ability to learn quickly, follow complex directions under pressure and multi-task
• Leadership, teamwork, initiative and sound judgement with confidential, regulated information

What we offer

• Estimated salary of $265-295K per year, depending on experience, qualifications and location
• Possible discretionary annual bonus, incentive compensation, stock-based long-term incentives and paid time off
• 401(k) with company match, medical, dental and vision plans
• Life, AD&D, disability, pet insurance, legal insurance, accident, critical illness and hospital indemnity insurance
• Employee Assistance Program, professional development, HSA and flexible spending accounts
• Mental health resources and paid leave for new parents