Job Description

The Associate Director/Director, Clinical Operations Program Leadership (COPL) is responsible for leading the strategy, planning and implementation of clinical development program operations in the Global Clinical Operations (GCO) organization and contributing as the lead program level GCO representative to the R&D Project Team and as called upon to the Product Development and Commercialization (PDC) Team.  

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 development plans, 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 serves as the program champion and hub of the program within the GCO 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. S/he facilitates communication between the project team and GCO (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 or multiple medium complexity clinical programs.

RESPONSIBILITIES:

• Leads the development and ongoing refinement of program level study timelines and scenarios   in order to contribute to the Integrated Development Plan (IDP) and other high-level strategic plans. 
• Provide rigorous, objective information (status and updates) and aligned GCO recommendations to R&D project team to support strategic project decisions 
• Takes overall accountability for GCO delivery of the clinical studies within a program and provide appropriate oversight to ensure a high quality, ethical, cost efficient way to meet timelines and patient recruitment goals
• Responsible for escalating CRO delivery issues to senior leadership at partner CRO and driving delivery of mitigation strategies to maintain program timelines.  Engages proactively with Biogen and partner stakeholders (e.g. CROs) and appropriately leverages GCO governance to support clinical program execution
• Responsible for the development and execution of a GCO program strategic operations plan  (GPS) taking into account the therapeutic area and underlying science and opportunities for innovation and operational consistency as well as the future clinical, regulatory, and commercial development plan for the molecule.  Proactively integrates stage-appropriate needs into operational strategy 
• Cascades the plan with within GCO to appropriate sub functions to establish vision and strategic framework for successfully delivery at the study level and with individual areas of technical expertise
• May participate as a functional contributor to due diligence/business evaluations including the review of external CDP and strategy, the development of internal timelines, scenarios and recommendations, the review of external capabilities and the development of GCO resource plans for potential new clinical candidates

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Qualifications

• Minimum experience requirements necessary to perform the job
• Undergraduate degree in a scientific or health related discipline. Advanced scientific or business degree or equivalent experience (MS/PhD/PharmD/MBA /MPH) preferred.
• Minimum of 10 years (12+ for Director) experience in drug development, clinical research and operational strategy experience including responsibility ensuring studies and programs are executed to quality, timelines and budget.  (at least part of this time in a Biotech/Pharma environment is preferred)
• Demonstration of project/program management skills including risk assessment, timeline and budget management and contingency planning.
• Demonstration of effective team leadership of matrix teams. Excellent communication, management and organizational skills, along with problem solving, conflict resolution, and team building skills.
• Experiencing identifying and leveraging relevant data and information to develop well-conceived and executable timelines.
• Experience across several complex therapeutic areas.  Scientifically and clinically agile, proven ability to learn and apply relevant disease information into strategic operational planning and delivery
• Deep operational expertise.  Experience planning and delivering global clinical programs and studies
• Experience facilitating the development of Clinical Development Plans (CDPs) with multiple functions strongly desired

EDUCATION REQUIREMENTS:

• Minimum educational level necessary to perform the job (High School diploma, Associate’s Degree, Bachelor’s Degree, Masters, PhD)

All your information will be kept confidential according to EEO guidelines.

Additional Information

Clinical Operations Program Leadership (COPL) is responsible for leading the strategy, planning and implementation of clinical development program operations in Biogen's Global Clinical Operations (GCO) organization and contributing as the lead program level GCO representative to the R&D Project Team and as called upon to the Product Development and Commercialization (PDC) Team.