Executive Director, Oncology R&D, Global Clinical Lead

Job Summary

Oversees multiple programs, alliances, large trials, such as a global clinical development program for multiple product candidates with one or more indications or a single large program with multiple Phase 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; is accountable for performance of CROs;

routine interactions with senior management of CROs/AROs as needed; is accountable for clinical development plans, protocol profiles and sections of key submission documents; represents Clinical Development as team leader or supervisor of team leaders; accounts for Clinical Development input into commercial strategy including Translational Medicine and biomarker strategy; serves as a thought partner in driving Business Development decisions in collaboration with the External Scientific Affairs department.

• Clinical Monitoring Planning: oversee and coordinate sponsor oversight of CRO clinical monitoring activities, including plan for internal communication and issue escalation with Clinical Study Lead (CSL).
• Clinical Surveillance: document ongoing clinical monitoring review of data for safety (with Clinical Safety Pharmacovigilance) and quality at project level, ensuring global consistency of clinical monitoring activities; define or contribute to department‑level surveillance activities across projects.
• Study strategy: interact with leaders of each function to develop study strategy; approve project or therapeutic‑area‑level translational medicine and biomarker strategy in collaboration with Translational Medicine and Clinical Pharmacology; attend regulatory agency meetings and lead clinical strategy discussions.
• Study planning and execution: develop prospective contingency plans for management of key risks across a large project or a portfolio of projects or across the therapeutic area; clearly define priorities and high‑level execution plans across projects within and outside Daiichi Sankyo; support effective communication and decision‑making process cross‑functionally and cross‑regionally at department level.
• Study outputs: for large studies/programs, consult on responses to IRBs and health authorities; have strong understanding of statistics and study design principles applicable to primary and efficacy and safety endpoints in registration trials to critically assess study conclusions.
• External collaboration: ensure continuous, effective alignment within/between CROs and vendors; for large, multiple‑indication projects in late development, develop and lead an advisory board with top‑tier key external experts for project‑level strategic advice; develop and lead steering committee for Phase 3 registration studies; consult with key external experts for advice on complex development or safety issues; maintain and lead external collaborations and advisory panels at department level.
• People management: assign staff with appropriate training and experience or arrange requisite support to lead large study teams, coordinate complex studies, lead projects, and/or ensure proper medical oversight; monitor and manage direct reports’ performance in such roles, ensuring proper understanding of task complexity and management of key risks; participate 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 relationship with top KOLs; thought partner with External Scientific Affairs on business development activities for late‑stage compounds; committee member for in‑licensing and acquisitions.

• MD with relevant clinical experience required. Postgraduate training in therapeutic area or related specialty required.
• 7 or more years of experience required.
• 4 or more years managing a clinical development group required.

USD$ – USD$

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.