Job Information
Ascendis Pharma Medical Director, Clinical Development, Endocrine Medical Sciences - Job: 1305 in United States
The Medical Director is involved in the design, safety monitoring, and data analysis of the Company’s late-phase clinical trials in endocrinology and rare diseases. As such, the Medical Director is an important and visible member of the clinical development team. The Medical Director position is based in the United States (preferably in Palo Alto, California; but okay with remote) and will report to the Senior Vice President, Clinical Development.
Key Responsibilities
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
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
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
Travel up to 20% domestically and internationally for scientific meetings
Requirements
M.D. degree
Completion of ACGME-accredited residency and fellowship (strongly preferred)
Physician licensure in at least one state (strongly preferred)
At least 5 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 an Associate Medical Director position.
At least 3 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
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
Estimated salary: $270,000-290,000/year DOE - Title and salary commensurate with experience.
A note to recruiters:
We do not allow external search party solicitation. Presentation of candidates without written permission from the Ascendis Pharma Inc Human Resources team (specifically from: Talent Acquisition Partner or Human Resources Director) is not allowed. If this occurs your ownership of these candidates will not be acknowledged.
Benefits
Medical insurance
Vision insurance
Dental insurance
401(k)
Paid maternity leave
Paid paternity leave
Commuter benefits
Disability insurance