Associate Director, Investigator Initiated Trials

BeOne Medicines • San Mateo, CA • 2h ago

General Description:

Responsible for the effective management of all aspects of Investigator-initiated Trials (IITs) including implementation in multi-institutions and research settings in accordance with FDA regulations and Good Clinical Practice guidelines. This role will also assist with program management, including use of the BeOne contract system for creating and tracking contracts and report creation through the IIT portal. Support the review process for medical affair studies.

Essential Functions of the Job:

Support IIT operations and project management, cross-functional collaborations, process improvement, and vendor management. This includes tracking and measurement of IIT KPIs.

Act as the Medical Internal Review Committee (MIRC) lead. Review submitted proposals and protocols, adjudicate revised proposals and protocols based on MIRC comments, set the MIRC agenda, develop the slides and content for the MIRC meeting, and create/distribute MIRC meeting minutes.

Responsible for circulating protocols for off-line MIRC review, adjudicating comments and creating meeting minutes and action items based on the final review.

Communicate comments from and the final decision of the MIRC review to the investigator and BeOne field medical team, including approval/decline letters.

Function as main point of contact with the IIT research team for select studies and communicate regularly with the research staff, including the investigators and BeOne field medical teams. Assist in study budget coordination with PI and BeOne. Support FMV evaluation and work with attorneys internally and externally as necessary in contract negotiations.

Support monthly study status report(s) and maintaining updated study information in the IIT portal.

Interface with the Accounting Departments to manage POs, record and reconcile all payment information and invoices for the studies managed.

Interface with Quality and Clinical Supply Chain colleagues as needed on studies managed.

Track study progress, for studies managed, including milestones and payments.

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.

Provide Operational assistance to field medical on trial and activities.

Level of position commensurate with experience.

Required Education:

BA/BS Degree is required, Advanced degree (MD/PharmD, MS) is preferred.

Required Qualifications:

MD/PharmD with 4 + years of experience within the pharmaceutical industry, clinical research, a consulting and/or CRO.

Masters Degree with 6 + years of experience within the pharmaceutical industry, clinical research, a consulting and/or CRO.

Bachelors Degree with 8 + years of experience within the pharmaceutical industry, clinical research, a consulting and/or CRO.

Strong project management skills.

Ability to plan, prioritize, and execute multiple projects; ability to multitask and work both independently and within multi-disciplinary teams.

Supervisory Responsibilities:

No direct reports.

Computer Skills:

Microsoft Office Suite

IIT tracking software

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