Oversees multiple programs, alliances, mega 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 biomarker strategy; Thought partner in driving Business Development decisions in collaboration with External Scientific Affairs dept.
- Study strategy: Interacts with leaders of each function to develop study strategy; Approves project or TA-level 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 mega-studies/programs, consults on responses to IRBs and HA; Has strong understanding of statistics and study design principles applicable to primary efficacy endpoints in registrational trials to critically assess study conclusions
- Medical Monitoring Planning (MD only): Oversees and coordinates Sponsor oversight of CRO Medical Monitoring activities, including plan for internal communication and issue escalation with Clinical Study Lead (CSL)
- Medical Surveillance (MD Only): Documents ongoing Medical Monitoring review of data for safety (with Clinical Safety Pharmacovigiliance) and quality at project level; Ensures global consistency of Medical Monitoring activities; Defines or contributes to department level surveillance activities across projects
- External collaboration: Ensure continuous, effective alignment within / between CRO and vendors; For large, multiple indication project in late development, develops and leads Ad-Board with top tier KOLs for project level strategic advice; Develops and leads steering committee for Phase 3 registrational study; Consults with KOLS for advice on complex development or safety issues; Maintains and leads 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 report's performance in such roles, ensuring that there is 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 Ext Scientific Affairs on Business Development activities for late stage compounds; Committee member, in-licensing and acquisitions
Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
- PharmD, PhD, MD, or equivalent; Postgraduate training in TA or related specialty, or past successes
- 8 years (3 years managing Clinical Development group)
- Strategic Thinking, Clinical Trials Knowledge, Influencing Skills, Scientific Knowledge, Therapeutic Expertise, Drug Development, Critical Thinking, Team Leadership.