Senior Medical Director, Clinical Development Endocrinology - Job ID: 2048

Key Responsibilities

• As the clinical lead of a therapeutic area within endocrinology, responsible for the formulation and implementation of the Clinical Development Plan
• Represent clinical development on the Project Core Team
• 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: oversee all aspects of the clinical monitoring process in accordance with ICH GCPs and global SOPs to assess the safety and efficacy of investigational products
• 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
• 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
• 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 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-certified (strongly preferred), with specialty in endocrinology or genetics 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.
• 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