Executive Director, Global Clinical Lead

About the role

Oversees multiple programs, alliances, large trials, such as global clinical development program for multiple product candidates with one or more indications or a single large program with multiple Ph II/III studies. Reviews regulatory documents from a cross-functional, holistic perspective. Provides senior-level clinical representation at meetings with health authorities. Leads the creation of developmental and regulatory strategy. Accountable for performance of CROs and routine interactions with senior management of CRO/ARO, as needed. Accountable for clinical development plans, protocol profiles, and sections of key submission documents. Represents Clinical Development as team leader or as supervisor of team leaders. Accountable for Clinical Development input into commercial strategy including Translational Medicine and biomarker strategy. Thought partner in driving Business Development decisions in collaboration with External Scientific Affairs department.

Responsibilities

• Clinical Monitoring Planning: Oversees and coordinates Sponsor oversight of CRO clinical Monitoring activities, including plan for internal communication and issue escalation with Clinical Study Lead (CSL).
• Clinical Surveillance: Documents ongoing Clinical Monitoring review of data for safety (with Clinical Safety Pharmacovigilance) and quality at project level; ensures global consistency of clinical Monitoring activities; defines or contributes to department-level surveillance activities across projects.
• Study Strategy: Interacts with leaders of each function to develop study strategy; approves project or TA-level Translational Medicine (TM) and biomarker strategy in collaboration with Translational Medicine and Clinical Pharmacology; attends regulatory agency meetings and leads clinical strategy discussions.
• Study Planning and Execution: Develops prospective contingency plans for management of key risks across a large project or a portfolio of projects or across the Therapeutic Area; clearly defines priorities and high-level execution plans across projects within and outside of Daiichi Sankyo; supports effective communication and decision-making process cross-functionally and cross-regionally at department level.
• Study Outputs: For large studies/programs, consults on responses to IRBs and health authorities; has strong understanding of statistics and study design principles applicable to primary and efficacy and safety endpoints in registrational trials to critically assess study conclusions.
• External Collaboration: Ensures continuous, effective alignment within/between CRO and vendors; for large, multiple-indication projects in late development, develops and leads Ad-Boards with top-tier Key External Experts (KEEs) for project-level strategic advice; develops and leads steering committees for Phase 3 registrational studies; consults with KEEs for advice on complex development or safety issues; maintains and leads external collaborations and advisory panels at department level.
• People Management: Assigns staff with appropriate training and experience or arranges requisite support to lead large study teams, coordinate complex studies, lead projects, and/or ensure proper medical oversight; monitors and manages direct reports’ performance in such roles, ensuring proper understanding of task complexity and management of key risks; participates in department’s planning for staff and cross-functional staffing plans for the Therapeutic Area.
• Additional Non-Study Related Activities: Routine senior management interactions; influential relationships with top Key Opinion Leaders (KOLs); thought partner with External Scientific Affairs on Business Development activities for late-stage compounds; committee member for in-licensing and acquisitions.

Requirements

• MD with relevant clinical experience required.
• Postgraduate training in Therapeutic Area (TA) or related specialty required.
• 7+ years of experience in clinical development required.
• 4+ years managing a Clinical Development group required.

Pay

Salary Range: USD $329,025.00 – USD $548,375.00