Medical Director, Clinical Development

Medical Director, Clinical Development

Ascendis Pharma

Hellerup, Denmark

We are seeking an energetic Medical Director to join our growing team. As a key member of the Ascendis Pharma team, you will play a crucial role in driving the design, safety monitoring, and data analysis of the Company’s late-phase clinical trials studying TransCon C-type natriuretic peptide (CNP). This is an exciting opportunity to work in a fast-paced environment, collaborate with cross-functional, global teams working together to achieve extraordinary results.

You will report directly to the VP, Clinical Science, Endocrine and Rare Disease Medical Sciences.

Your key responsibilities will be

• 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.

Requirements

Qualifications and Skills:

• M.D. degree;
• Ph.D. degree (strongly preferred);
• Completion of an accredited residency and fellowship (strongly preferred);
• Physician licensure (strongly preferred);
• Board-certified (strongly preferred), with specialty in pediatrics, genetics, or endocrinology 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;
• Strong track record of scientific and clinical inquiry;
• Possess excellent communication skills (written and oral);
• Demonstrate sound judgement in terms of handling complex, confidential, and regulated information.

Key competencies:

You have excellent communication skills, both written and verbal, and you learn quickly, even when working under pressure. You’re able to follow complex instructions, multitask effectively, and still maintain a strong attention to detail. You lead confidently - both through your actions and when guiding others - and you’re known for being a trustworthy, collaborative team player. You take initiative, solve complex problems with ease, and demonstrate sound judgment, especially when handling confidential, sensitive, or regulated information