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Ascendis Pharma is a global biopharmaceutical company advancing programs in endocrinology rare disease and oncology. The company uses its proprietary TransCon® drug development platform to develop potentially best-in-class therapies for unmet medical needs.
The Senior Medical Director will serve as the clinical lead for a therapeutic area within endocrinology, driving the design, safety monitoring, and data analysis of late-phase clinical trials. This is a key leadership role within the clinical development team, reporting to the Vice President of Clinical Development, Endocrinology.
Key responsibilities include:
- Formulating and implementing the Clinical Development Plan as the clinical lead of an endocrinology therapeutic area
- Representing clinical development on the Project Core Team
- Providing leadership to study teams and medical monitors
- Designing clinical trials, providing overall oversight, and supporting site and subject retention
- Serving as medical monitor for clinical trials to ensure study integrity and track safety/efficacy data
- Overseeing all aspects of the clinical monitoring process in accordance with ICH GCPs and global SOPs
- Ensuring successful completion of trial-related documents (protocols, investigator brochures, monitoring plans, clinical study reports, regulatory submissions)
- Analyzing, evaluating, interpreting, and reporting clinical data
- Anticipating and solving complex drug development problems
- Contributing to regulatory strategy and clinical documentation
- Collaborating with cross-functional teams (clinical operations, statistics, regulatory affairs, medical affairs, commercial, finance)
- Cultivating relationships with investigative sites, clinical consultants, and key opinion leaders
- Assisting in portfolio management and commercial activities
- Traveling up to 20% domestically and internationally for scientific meetings
Requirements:
- M.D. degree (required)
- 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 certification (strongly preferred), with specialty in endocrinology or genetics highly desired
- At least 10 years of industry experience (post-graduate experience in clinical and/or academic settings may be considered on a case-by-case basis; those with less experience may be considered for a Medical Director position)
- Excellent written and oral communication skills
- Ability to learn quickly and follow complex directions under pressure
- Strong organizational and attention-to-detail skills
- Leadership capability both directly and by example
- Collaborative team player with initiative and problem-solving ability
- Sound judgment in handling complex, confidential, and regulated information
