Executive Medical Director, Clinical Development Hematology

Role Overview

The Executive Medical Director (EMD) is responsible for overseeing 2 or more clinical development programs, providing oversight, guidance, and mentoring to Medical Directors and Clinical Development Scientists, and serving on cross-asset strategic teams. The role provides medical leadership and input to Program Teams during early to late-stage drug development, from IND/CTA and First-in-Human through Proof-of-Concept and End-of-Phase-2 and beyond.

Responsibilities

• Typically lead 2 program teams and drive successful execution of clinical studies, programs, and research strategies; define and manage the benefit-risk profile of products
• Represent Clinical Development on the Global Program Team and Global Medicine Team in presentations at management and review committees
• Advance understanding of the impact of therapies on the pathophysiology of rare and orphan diseases through scientific discourse and data interpretation
• Foster development of Medical Directors, Clinical Development Scientists, and/or fellows
• Lead and oversee preparation and execution of clinical development strategy and related documents including protocols, charters, statistical summary reports, meeting presentations, publications, and clinical sections of regulatory documents
• Provide scientific and medical input to R&D, commercial, translational, medicine, and business development functions; lead or oversee clinical activities to support due diligences
• Represent Clinical Development to internal and external academic, regulatory, and medical communities
• Oversee a cross-functional team developing the clinical components of the Clinical Development Plan
• Serve as clinical input to the Global Development Team and medical expert for the clinical study team
• Oversee writing of clinical sections of the CTD, white papers, expert opinion reports, and regulatory responses
• Coordinate communications and planning between medical functions related to clinical development study design, execution, and interpretation of results
• Serve as medical expert on the global product labeling team
• Drive awareness of scientific, clinical, competitive, and regulatory developments that could impact the development plan
• Drive clinical support of business development activities such as due diligence and research collaborations
• Critically evaluate information about diseases of interest and the competitive landscape and synthesize information to support clinical development programs, asset plans, and therapeutic area strategy
• Determine appropriate advisory board experts
• Work as part of a cross-functional team with biostatistics, data management, clinical pharmacology, commercial, regulatory, and project management colleagues
• May supervise other medical monitors on individual studies

Requirements

• M.D. or equivalent
• 7+ years of experience in clinical development; clinical research, global regulatory, and product development expertise
• Has prepared documents and attended regulatory meetings with FDA and other regulatory agencies
• Experience designing and executing multinational clinical trials required
• Demonstrated ability to lead cross-functional teams to define clinical strategy and clinical study design
• Experience supporting business development activities
• MD or equivalent, preferably with clinical training
• PhD in related discipline desirable, but not required

Preferred Qualifications

• Advanced knowledge of the assigned therapy area is desired, with the capability to interpret, discuss, and represent trial or program level data
• 7+ years of experience in industry in clinical development is preferred