Director, GCO Clinical Program Lead (GCPL)

When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process.  Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.

·       In coordination with Franchise Head, Accountable to the Franchise ERC, DCT and other governance teams as appropriate as GCO representative, to provide clinical operational insight to drive the program strategy and ensure excellence in execution.

·       Lead/participate in the KOL engagement activities in the designated programs and may act as function spokesperson if needed.

·       Evaluate and develop strategic feasibility and budget estimates during Early Planning for new CDPs and upon strategy change during the conduct of a study, where needed.

·       Accountable for resource allocation and initiating CST formation; ensures appropriate transition of outputs from early planning to the gCSM.

·       Create and be accountable for the annual program budget and resource forecasts, as well as contributing to and tracking the relevant DCT goals for the program.

·       Create, review, and provide input to and maintain compound-level documents such as IB, DSUR, and protocol.

·       Oversee timely, quality, and efficient study planning and execution of associated studies within the allocated program.

·       Conduct regular program review meetings to mentor, support, and ensure all studies are tracking to the DCT/DRC-approved budget and timeline.

·       Report on study status, goals, and operational KPIs, and enforce quality KPIs with support from the Compliance team.

·       Collaborate with other GCPLs to evaluate and designate preferred global vendors and participate in vendor governance meetings.

·       Create or review performance and development plans for direct reports, facilitate and support delivery of performance and development goals.

·       Provide line management and mentorship to gCSMs working within the designated program(s).

·       Inspire and lead efforts to deepen scientific knowledge within the Clinical Operations’ function.

·       Champions a global mindset and approach across Clinical Operations to foster collaboration and consistency across the organization.

·       Provide expert knowledge on the execution of clinical trials through a deep understanding of ICH/GCP Guidelines and other applicable regulatory requirements.

·       Point of escalation for all compound-related issues.

·       Identify and drive process improvement initiatives in collaboration with Franchise Head and/or other GCPLs within program.

·       Collaborates with cross-functional leaders to provide operational perspectives to enable effective and efficient delivery of clinical development goals.

Supervisory Responsibilities: Line-manages direct reports of Global Clinical Study Managers (gCSMs).

Computer Skills: MS Office; Project Planning Applications; Clinical Trial Management Systems (CTMS)

Travel: Up to 20%. Ability to travel domestically and internationally.