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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 of the medical tactical plan and/or annual operating plan for IITs.

+ Leads overall division strategy for our Investigator Initiated Trials and Research, which may lead to clinical data needed for regulatory submissions, go-no go, and publications.

+ Directs and manages Investigator-Initiated clinical research studies.

+ Evaluates and analyzes clinical data to align with strategic recommendations and direction of IIT program.

+ Liaison for Medical Directors and strategy as well as lead cross-functional meetings to discuss studie and related to supply chain and forecasting of IITs.

+ Oversee the tracking and reporting on the progress of IITs studies, including budget and timelines.

+ Identify and mitigate quality risk and/or issues associated with assigned studies/activities.

+ Has oversight of data collection compliance via tracked milestones.

+ Responsible for the execution of clinical projects while adhering to budget, scope and schedule requirements.

+ Oversees clinical trial agreement negotiations to ensure efficient and timely processing of clinical trial agreements.

+ Leads the operations team to identify and implement ways to improve the Global IIT program and process.

+ Ensure operational aspects of the studies being conducted in accordance with all relevant ethical and government standards, GCP’s and Standard Operating Procedures.

+ Collaborate with key opinion leaders to identify issues or barriers related to the research request execution.

+ Demonstrate excellent organizational, decision-making, and time management skills in a fast-paced environment.

Supervisory Responsibilities:

+ Manage, mentor, and evaluate team members, actively supporting, coaching, and enabling their success.

+ Assess workloads and allocate time and resources.

+ Manage recruiting, onboarding, and training of new team members.

+ Evaluate performance, mentor, and provide ongoing feedback to team members who have a range of experience.

+ Identify growth focus areas, training, and professional development opportunities.

+ Ensure team engagement and culture, ensuring needed communication to and within the team.

Education Required:

+ MD, Pharm.D. PhD., or quivalent.

Qualifications Required:

+ Pharm.D. or PhD., with 12+ years of related experience.

+ Skill in creating data extracts and or reports from the system.

+ Knowledge and proficient skill level with Report Writers.

+ Strong project management skills.

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

Computer Skills:

+ Microsoft Office Suite

+ Clinical Trial Management Software (CTMS) or other study management software.

+ Familiarity with Veeva MedComms or Veeva PromoMats a plus.

Travel:

+ Remote or San Mateo; 10-15% travel

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.