Director, Clinical Operations Program Leadership (COPL)

Biogen; North Carolina; On-site; USD 230,000 - 330,000; Full time

Job summary

Biogen is seeking a Director, Clinical Operations Program Leadership to drive strategy, planning and execution for clinical development programs within the QSDO organization. The role partners with DAT and PDC to align operational plans with asset strategies and governance milestones.

The incumbent brings deep Biotech/Pharma program operations experience, leads complex programs, and ensures studies meet timelines, quality, and budget expectations while coordinating with CROs, vendors and

Qualifications

• Undergraduate degree in a scientific or health related discipline. Advanced scientific or business degree or equivalent experience preferred.
• Minimum of 12 years' Biotech/Pharma experience in drug development, clinical research and operational strategy.
• Demonstration of project/program management skills including risk assessment and mitigation, timeline and budget management.

Responsibilities

• Leads development and ongoing refinement of program level study timelines and scenarios for Integrated Asset Plan and strategic plans.
• Provide rigorous, objective information and recommended actions to support strategic project decisions.
• Takes overall accountability for QSDO delivery of clinical studies within a program with governance timelines and patient recruitment goals.
• Lead COPL input and governance presentations ensuring the operational voice is integrated.
• Engage with Biogen and partner stakeholders to support clinical program execution and escalate vendor delivery issues for risk mitigation.
• Develop and execute a QSDO Program Operational Plan accounting for therapeutic area and long-term development plans.
• May participate in due diligence and review of external CDP and strategy, including timelines and resource plans.

Skills

Project management

Strategic planning

Stakeholder communication

Risk management

Education

BS in science/health

MS/PhD/MBA preferred

Job description

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.

What You'll Do

• 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.
• Ability to learn and adapt to the organizational governance framework and associated processes. Accountable to lead the COPL input and development of governance presentations and/or memos including integration of the operational voice. Ability to engage/communicate key messages, including risks, to senior and executive level functional leaders outside of QSDO. Ability to reach technical alignment on governance materials with the Head of QSDO and Head of CTDU in accordance with associated governance timelines.
• Engage proactively with Biogen and partner stakeholders (e.g. CROs, vendors) and appropriately leverage QSDO governance to support clinical program execution. Responsible for escalating CRO/FSP, vendor delivery issues to senior leadership at vendor partner level, driving delivery of risk mitigation strategies to maintain and deliver program timelines.
• Responsible for the development and execution of a QSDO Program Operational Plan (POP) accounting for 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 POP within QSDO 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 QSDO resource plans for potential new clinical candidates.

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.
• Minimum of 12 years' experience within a Biotech/Pharma environment in drug development, clinical research and operational strategy experience, ensuring studies and programs are executed to quality, timelines and budget. At least 3 years of this time in a Biotech/Pharma Program Operational Delivery capacity is required.
• Demonstration of project/program management skills including risk assessment and identification of mitigations, timeline and budget management