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

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.

Benefits

• Medical insurance
• Vision insurance
• Dental insurance
• 401(k)
• Paid maternity leave
• Paid paternity leave
• Commuter benefits
• Disability insurance