Demand Planning Director
Scandinavian Tobacco Group
ERP
Senior Director, Investigator-Initiated Trials & Expanded Access Programs, Global Medical Affairs
BeOne Medicines
full-time
Posted on:
Location: 🇺🇸 United States
Visit company websiteSalary
💰 $226,000 - $296,000 per year
Job Level
Senior
Tech Stack
Google Cloud Platform
About the role
- Senior Director, IIT & Expanded Access Programs in Global Medical Affairs; remote-based position with direct reports\n
- Responsible for strategic management of IITs, Expanded Access Programs, and Phase IV BeOne-Sponsored studies, including implementation in multi-institutions and research settings in accordance with FDA regulations and Good Clinical Practice guidelines, tracking and budgeting\n
- Lead IIT, EAP and Phase IV BeOne-sponsor study programs within Global Medical Affairs; interface with internal/external stakeholders; oversee review processes and budgeting\n
- Functions as a leader and mentor for external coordinators, physicians, and other members of the Medical Operations team; collaborate with cross-functional colleagues in Regulatory, Quality, and Clinical Supply Chain\n
- Manage the IIT trial management system and tracking of IITs, EAPs, Phase IV studies and post-hoc analyses; manage Trial Management Software vendor; implement changes based on business needs\n
- Liaise with Attorneys for contract negotiations; ensure ethical and government standards (GCP) and SOPs; ensure accurate payments and reporting\n
- Provide operational leadership to Medical Directors and Field Medical staff on IIT study proposal submission and activities; coordinate with key opinion leaders to identify issues or barriers to research request execution\n
- Maintain monthly study status reports and metrics; collaborate with Accounting to reconcile payments; monitor budgets across projects\n
- Lead cross-functional meetings; support/lead development of department policies; drive improvements to IIT program and processes\n
- Ensure compliance with data collection and tracking milestones; support post-hoc analyses and publications as needed
Requirements
- MD, Pharm.D. or PhD., or equivalent\n
- MD, Pharm.D. or PhD., with 12+ years of related experience\n
- Strong project management skills\n
- Ability to plan, prioritize, and execute multiple projects; multitask and work both independently and within multi-disciplinary teams\n
- Skill in creating data extracts and or reports from the system\n
- Knowledge and proficient skill level with Report Writers\n
- Travel: 10-15% travel; Remote or San Mateo\n
- Microsoft Office Suite; CTMS or other study management software; Veeva MedComms or Veeva PromoMats a plus
