Executive Director, Clinical Development (MD)

Responsibilities

• Leads or otherwise oversees and directs the development of the Target Product Profile and Clinical Development Plan for assigned molecules/products.
• Works closely with cross-functional leaders and teams to develop, implement and oversee the clinical development strategy for the assigned molecules / products.
• Routinely represents the assigned products in cross-functional steering and/or governance committees.
• Leads or otherwise oversees and directs clinical trial protocol design and clinical study reporting for assigned molecules/products.
• Leads both written and oral communications with health authorities.
• Provides or oversees ongoing medical monitoring for clinical trials, including but not limited to assessment of eligibility criteria, toxicity management, and drug safety surveillance.
• Leads or otherwise oversees and directs the clinical development component(s) in the preparation/review of regulatory documents, investigator brochures and development plans.
• Oversees and directs as needed the collection and assimilation of ongoing data for internal analysis and review and the preparation and/or review of data listings, summary tables, study results and scientific presentations.
• Presents scientific information at scientific conferences as well as clinical study investigator meetings.
• Where applicable, takes a lead on authoring scientific publications.
• May assist in the clinical evaluation of business development opportunities.
• Develops thought leader and other external relationships that can guide short and long-range clinical development strategies and direction for the disease or therapeutic area overall.
• Adheres to regulatory requirements inclusive of GCP and ICH guidelines of study conduct, and industry practices and standards including internal SOPs.
• Typically manages a team of direct reports.

Basic Qualifications

MD/DO and 8+ years of clinical, scientific and/or drug development experience in the biopharma industry, healthcare, consulting, academia, or a related environment.

Preferred Qualifications

• Board certification in hematology and/or medical oncology is preferred, including familiarity with clinical oncology.
• Experience in the biopharma industry is strongly preferred; submissions and conducting phase 2-3 late development studies.
• Experience in multiple myeloma disease area, and cellular therapy therapeutic area is strongly preferred.
• Extensive experience leading high-complexity cross-functional drug development strategies and plans in life sciences, healthcare, consulting, or academia, including short- and long-range strategic planning, governance, and oversight.
• Multiple years’ line management (direct reports) experience is preferred.
• Extensive experience interacting with and presenting to executives and managing large-scale budgets and other resources is strongly preferred.
• Proven track record of achieving or exceeding large-scale, complex short and long-range strategies in life sciences, healthcare, consulting, or academia.
• Expert-level of knowledge of drug development, as evidenced by proven track record in setting short and long-range drug development strategies and plans.
• Thorough understanding of pharmaceutical regulatory requirements and impact on development and execution of clinical trials.
• Excellent communication and organizational skills.
• Able to distill complex matters into a clear business case and roadmap for execution.
• Demonstrated ability to align other leaders and garner their commitment and engagement to cross-functional strategies, plans, and strategic objectives.
• When needed, ability to travel.