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

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

General Description:

We currently have an exciting opportunity available for an experienced Senior Director, Investigator-Initiated Trials (IIT) and Expanded Access Programs in Global Medical Affairs. The ideal candidate will be responsible for effective strategic management of all aspects of investigator-initiated studies, 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. This role will be instrumental in planning and executing GMA programs and will require the ability to collaborate across other GMA functions and non-medical functions (e.g., Marketing, Market Access, HEOR, Legal, Compliance, Regulatory, etc.). This position will also assist with program management, including management of the IIT trial management system and tracking of IITs, EAPs, Phase IV studies and create the structure for review of post-hoc analysis requests. This is a Remote-based position with direct reports. He/she will also provide line management, people development, and performance management as well as support/lead development and implementation of department policies.

This role serves as an established, internal scientific/medical expert for therapeutic area, contributing to US product strategy in collaboration with other functions that drive product clinical development.

Provides expert medical/scientific advice and guidance to support the needs of our Investigator Initiated Trials. Continually seeks to develop relationships with outside organizations/experts to support research programs, clinical development programs, focused on our Investigator Initiated Research and Trials.

Essential Functions of the job:

• Work closely with internal stakeholders to execute the medical plan along with key initiatives and strategies to support the global utilization of related BeiOne products.
• Lead the IIT, EAP and Phase IV BeOne-sponsor study programs within Global Medical Affairs.
• Functions as a leader and mentor for external coordinators, physicians, and other members of the Medical Operations team.
• Manage the budget across projects.
• Oversee the internal review process for IITs, RWE studies, Phase IV BeOne-sponsored studies and post-hoc analyes.
• Interfaces with Attorneys internally and externally as necessary in contract negotiations.
• Collaborate with facilitating review and approval of Services Agreements related to investigator sponsored research and compassionate use programs.
• Leads as company liaison with external physicians, vendors, and hospital departments on all study related details.
• Creates monthly study status report(s), maintains study metrics and reports
• Interfaces with the Accounting Department to record and reconcile all payment information.
• Interfaces with cross-functional colleagues in Regulatory, Quality, and Clinical Supply Chain.
• colleagues as needed to support ISR program.
• Leads the IIT study progress, milestones, and payments within trial management software tool.
• Manages Trial Management Software vendor, recommending and implementing changes to system based on business need.
• Evaluates study protocols with appropriate staff members for suitability and feasibility.
• Strong interpersonal skills for effective professional communications, aiming to cultivate strong working relationships with both internal and external groups.
• Ability to effectively communicate complex medical/scientific information.
• Ability to influence without authority.
• Provide Operational leadership to Medical Directors and Field Medical staff on IIT study proposal submission and activities.

Expertise:

• Possesses deep therapeutic knowledge of medical affairs and clinical development.
• Keeps abreast of current medical/scientific progress and actively develops and maintains relationships with outside experts aligned with the scientific objectives and business objectives of the Therapeutic Area Section.
• Works to understand the evolving healthcare environment (provider/expert) and payor landscapes and help to translate that working knowledge into a plan.
• Provides input into the therapeutic area strategy including participation in the Integrated Brand Planning.
• Co-development and implementation of the annual therapeutic or indication section o