Senior Director, Global Clinical Operations Franchise Head, Hematology

• Bachelor or higher degree in a scientific or healthcare discipline with 12+ years’ experience in clinical trial industry
• Both Project and Program management experience across the entire lifecycle of multi-region/country clinical trials in a fast paced global environment, with proven excellent record and accomplishments in related GCO areas and demonstrated good leadership capabilities/ potential
• 3+ years of leadership and people management experience is required, including 3+ years of leadership and people management experience at managing senior manager level above persons, and experience of 2nd line management preferred
• 3+ years experience in Hematology cancers preferred

Essential Functions of the job

• Strategic leadership and management
• Accountable and responsible for building, developing and retaining the global team of GCPL/gCSM, including hiring, training, mentoring, developing direct and indirect reports, performance appraisals and resource management
• Oversee the delivery and goal achievement of programs and projects within the designated Franchise(s)- therapeutic area(s) or asset(s), serving as the point of escalation for resolving issues that GCPLs cannot resolve
• Collaborate with the other Franchise Heads to define and implement strategies and key priorities, and establish global standards for goals, key performance measures, and capability development for the GCPL/gCSM roles
• As a member of the leadership team within GCO P&SM, participate in the decision making and strategy shaping in P&SM,, and collaborate with other P&SM LTs to lead functional management activities, process optimization initiatives, and streamline process across franchise(s)-therapeutic area(s) or asset(s)
• GCO Representative for the designated Franchise(s)-therapeutic area(s) or asset(s)
• Accountable to the Franchise ERC, DCT and other governance teams as appropriate as GCO representative, to provide clinical operational insight to drive the Therapeutic/Asset strategy, and ensure excellence in execution
• Lead/participate in the KOL engagement activities in the designated franchise(s)- therapeutic area(s) or asset(s) and may act as function spokesperson if needed
• Program Management
• 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 annual budget and resource forecasts, as well as relevant DCT goals for the program
• Create, review, and provide input to maintain compound-level documents such as IB, DSUR and protocol
• Provide guidance to the CST and ensure timely, quality, and efficient study planning and execution of associated clinical programs/studies
• Conduct regular program review meetings to mentor, support, and ensure all studies within the program are tracking to budget and timeline
• Report on program/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 direct reports
• 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 program -related issues
• Identify and drive process improvement initiatives in collaboration with other Franchise Heads and GCPLs
• Collaborates with cross-functional leaders to provide operational perspectives to enable effective and efficient delivery of clinical development goals