Executive Director, Oncology R&D, Global Clinical Lead

Job Summary

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 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; 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 dept.

Responsibilities

• Job Description 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)
• Job Description Clinical Surveillance: Documents ongoing Clinical Monitoring review of data for safety (with Clinical Safety Pharmacovigiliance) and quality at project level
• Job Description Study strategy: Interacts with leaders of each function to develop study strategy
• Job Description 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
• Job Description Study Outputs: For large-studies/programs, consults on responses to IRBs and HA
• Job Description External collaboration: Ensure continuous, effective alignment within / between CRO and vendors
• Job Description Additional Non-Study related activities: Routine senior management interactions; Influential relationship with top KOLs; Thought partner with Ext Scientific Affairs on Business Development activities for late stage compounds

Qualifications

• Education Qualifications: MD with relevant clinical experience required Postgraduate training in TA or related specialty required
• Experience Qualifications: 7 or More Years experience required 4 or More Years managing Clinical Development group required

Additional Information

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. Salary Range USD$329,025.00 - USD$548,375.00