[Remote] Director, GCO Clinical Program Lead (GCPL) – Early Phase
Note: The job is a remote job and is open to candidates in USA. BeOne Medicines is a rapidly growing company focused on fighting cancer, seeking a Director, GCO Clinical Program Lead for Early Phase programs. This role involves strategic operational planning, leadership of global teams, and collaboration across various functions to ensure program success and execution excellence.
Responsibilities
- Accountable and responsible for building, developing and retaining the global team of gCSM, including hiring, training, mentoring, developing direct and indirect reports, performance appraisals and resource management
- Oversee the delivery and goal achievement of projects within the designated program(s), serving as the point of escalation for resolving issues that gCSM cannot resolve
- Collaborate with the other GCPLs and Franchise Heads (FH) 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 Early Phase program(s)
- 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
Skills
- Bachelor or higher degree in a scientific or healthcare discipline with 10+ years' progressive experience in clinical trial industry
- Proven project and program management experience in Early Phase clinical trials; First-In-Human experience favored
- Proven project management exposure/experience across the entire lifecycle of multi-region/country clinical trials in a fast-paced global environment
- Experience in both people management and program management preferred
- Expert knowledge on the execution of clinical trials through a deep understanding of ICH/GCP Guidelines and other applicable regulatory requirements
- Strong global program management skills
- Ability to provide strategic leadership and management
- Experience in building, developing and retaining a global team
- Ability to oversee timely, quality, and efficient study planning and execution
- Ability to collaborate with cross-functional leaders to provide operational perspectives
- Strong analytical thinking/data analysis skills
- Ability to communicate with clarity
- Oncology experience preferred
- Experience in both people management and program management preferred
Benefits
- Non-Commercial roles are eligible to participate in the annual bonus plan
- 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
- 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
Company Overview
Company H1B Sponsorship