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General Description:

+ Leveraging deep Therapeutic Area expertise, solid global program management skills, global view, and borderless leadership, the GCPL is accountable for the strategic operational planning and clinical operational performance of designated programs to act as a point of escalation for the resolution of issues on the studies within responsible program(s).

+ Lead the Global Clinical Study Managers (gCSMs) in designated programs while providing inspirational leadership, facilitating proactive risk and issue management, and delivering feedback-oriented mentorship to the gCSM line reports, and fostering talent development.

+ Partner with other program leads/cross-functional representatives in BeiGene R&D to drive disease/asset strategy and ensure execution excellence by contributing clinical operations insights and expertise at the program level.

+ This is a global management role and requires working with colleagues in various time zones.

Essential Functions of the job:

Strategic leadership and management

+ Accountable and responsible for building, developing and retaining a global team of gCSM, including hiring, training, mentoring, developing direct and indirect reports, performance appraisals and resource management.

+ Oversee the delivery of goals and metrics on projects within the designated program(s), while serving as the point of escalation for resolving issues that gCSM cannot resolve.

+ Collaborate with the other GCPLs to define and implement strategies and key priorities across-programs, and establish global standards for goals, performance measures, and capability development for the gCSM roles.

+ GCO Representative for the designated program(s)

+ In coordination with GCO Franchise Head, accountable to the Therapeutic Indication and Franchise 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 KOL engagement activities in the designated programs and may act as function spokesperson if needed.

Program Management

+ Evaluate and develop strategic feasibility and budget estimates during Early Planning for new Clinical Development Plans (CDPs) and upon strategy change during the conduct of a study, where needed.

+ Accountable for resource allocation and initiating Clinical Study Team (CST) formation; ensure appropriate transition of outputs from early CDP planning to the gCSM at study start.

+ In coordination with GCO Franchise Head, create and be accountable for the annual program budget and resource forecasts, as well as contributing to and tracking the relevant 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 governance-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.

+ Champion 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 on assigned program(s).

+ 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 managing direct reports comprising of gCSMs

**Computer Skills:** Proficiency in MS Office Suite, including Excel, Power Point, and Project.

• **Other Qualifications:**

+ Fluent in written and verbal English.

+ Strong project management skills, including ability to work independently, lead multiple projects simultaneously and consistently meet or exceed project deadlines in a fast-paced environment

+ Ability to seek and utilize benchmark data to monitor and champion opportunities to accelerate project timelines without compromising quality

+ Strong working knowledge of ICH Guidelines, Good Clinical Practices, and Regulatory Agency requirements

+ Proven ability to make sound judgement and decisions. Possess the ability to quickly assess problems/situations and provide effective resolution/solution.

+ Excellent interpersonal skills and the ability to build and maintain positive work relationships to effectively interface at all levels across the organization.

+ Detail-oriented without losing sight of the big picture.

+ Organized, self-motivated, action and goal-oriented with exceptional follow through.

**Travel:** As Needed

**Location:** US/Canada

Education Required:

Bachelor or higher degree in a scientific or healthcare discipline with 10+ years’ experience in clinical trial or drug development in the biotech/ pharmaceutical/CRO industry or the relevant clinical research field.

Minimum of 5 years of project/program management experience.

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.