Leads the development and ongoing refinement of program level study timelines and scenarios in order to contribute to the Integrated Asset Plan (IAP) and other high-level strategic plans.
Provide rigorous, objective information (status and updates) and aligned QSDO recommendations to DAT to support strategic project decisions.
Takes overall accountability for QSDO delivery of the clinical studies within a program and provides appropriate oversight to ensure a high quality, ethical, cost-efficient way to meet governance approved timelines and patient recruitment goals.
Required Skills
Undergraduate degree in a scientific or health related discipline. Advanced scientific or business degree or equivalent experience (MS/PhD/PharmD/MBA /MPH) preferred.
Demonstration of project/program management skills including risk assessment and identification of mitigations, timeline and budget management
Benefits
Health insuranceVision insurance
Additional Information
The Director, Clinical Operations Program Leadership (COPL) is responsible for leading the strategy, planning and implementation of clinical development program operations in the Clinical Trial Delivery Unit of the Quantitative Science Development Operations organization (QSDO). The COPL is a key contributor as the lead program level QSDO representative to the Development Asset Team (DAT) and as called upon to the Product Development and Commercialization team (PDC). This individual is responsible for providing advanced functional and technical expertise and insights from both a strategic (decision points, risk) and operational (timeline scenarios, feasibility & financials) perspective to meaningfully contribute and make recommendations to Integrated Asset Plans (IAP), clinical development plans, and other key plans and initiatives necessary to advance Biogen clinical programs. The COPL is accountable for the strategy, planning, oversight and delivery of program level clinical operations deliverables. The COPL is accountable for developing a high-level clinical study operational strategy based on the CDP and key program level objectives. The COPL is accountable to bring the "operational voice" into governance meetings and presentations.
The COPL serves as the program champion and hub of the program within the QSDO organization. This individual develops and oversees implementation of program operational strategy, ensuring appropriate considerations that include but are not limited to technical, vendor, quality site/ Investigator, geographical and patient centric considerations for the program lifecycle. She/He facilitates communication between the DAT and QSDO (inclusive of leadership and sub-functions) to provide direction, incorporate appropriate risk management measures and ensure resolution of technical issues. This individual may be responsible for one highly complex, multiple medium complex clinical programs and/or programs with external collaborators.
Biogen · Cambridge, MA