Medical Director, Clinical Development, Endocrine Medical Sciences - Job: 1305

Ascendis Pharma

Ascendis Pharma

United States
Posted on Thursday, February 8, 2024

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