BeOne Medicines

Senior Director, Investigator-Initiated Trials & Expanded Access Programs, Global Medical Affairs

BeOne Medicines

full-time

Posted on:

Origin:  • 🇺🇸 United States

Visit company website
✨ AI Apply
Manual Apply

Salary

💰 $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