Director, Clinical Operations Program Leadership (COPL)

About the Role

The Director, Clinical Operations Program Leadership (COPL) leads the strategy, planning, and implementation of clinical development program operations within the Clinical Trial Delivery Unit of the Quantitative Science Development Operations organization (QSDO). This role serves as the lead QSDO representative to the Development Asset Team (DAT) and the Product Development and Commercialization team (PDC), providing advanced functional and technical expertise to contribute to Integrated Asset Plans (IAP), clinical development plans, and other key initiatives.

The COPL is accountable for the strategy, planning, oversight, and delivery of program-level clinical operations deliverables, including developing a high-level clinical study operational strategy based on the Clinical Development Plan (CDP) and program objectives. This individual acts as the "operational voice" in governance meetings, champions the program within QSDO, and ensures alignment across technical, vendor, quality, site/investigator, geographical, and patient-centric considerations throughout the program lifecycle.

The role facilitates communication between the DAT and QSDO, incorporating risk management measures and resolving technical issues. The COPL may oversee one highly complex, multiple medium-complexity clinical programs, and/or programs with external collaborators.

Responsibilities

• Leads the development and refinement of program-level study timelines and scenarios to contribute to the Integrated Asset Plan (IAP) and other high-level strategic plans.
• Provides rigorous, objective information and aligned QSDO recommendations to the DAT to support strategic project decisions.
• Takes accountability for QSDO delivery of clinical studies within a program, ensuring high quality, ethical, and cost-efficient execution to meet governance-approved timelines and patient recruitment goals.
• Adapts to the organizational governance framework and associated processes, leading the development of governance presentations and memos that integrate the operational voice.
• Engages and communicates key messages, including risks, to senior and executive-level functional leaders outside of QSDO, reaching technical alignment with the Head of QSDO and Head of CTDU.
• Proactively engages with Biogen and partner stakeholders (e.g., CROs, vendors) and leverages QSDO governance to support clinical program execution, escalating delivery issues and driving risk mitigation strategies.
• Develops and executes a QSDO Program Operational Plan (POP) that accounts for therapeutic area, underlying science, innovation opportunities, and the future clinical, regulatory, and commercial development plan for the molecule.
• Integrates stage-appropriate needs into operational strategy and cascades the POP within QSDO to establish a vision and strategic framework for successful delivery at the study level.
• May participate as a functional contributor to due diligence/business evaluations, including reviewing external CDPs, developing internal timelines and recommendations, assessing external capabilities, and planning QSDO resources for potential new clinical candidates.

Requirements

• Undergraduate degree in a scientific or health-related discipline; advanced scientific or business degree (MS/PhD/PharmD/MBA/MPH) or equivalent experience preferred.
• Minimum of 12 years of experience in a Biotech/Pharma environment in drug development, clinical research, and operational strategy, with at least 3 years in a Biotech/Pharma Program Operational Delivery capacity.
• Demonstrated project/program management skills, including risk assessment, timeline and budget management, and contingency planning.
• Proven ability to lead teams and influence matrix teams effectively.
• Excellent communication, time management, organizational, problem-solving, conflict resolution, and team-building skills.
• Experience identifying and leveraging relevant data to develop well-conceived and executable timelines.
• Experience across multiple complex therapeutic areas, with the ability to apply disease knowledge to strategic operational planning and delivery.
• Deep operational expertise in planning and delivering global clinical programs and studies across all stages of development (Ph 1-4) and lifecycle management (LCM).
• Experience facilitating the development of Clinical Development Plans (CDPs) with multiple functions is strongly desired.

Pay

The base compensation range for this role is $209,000.00–$288,000.00. Base salary is determined through an analytical approach considering skills, experience, job location, and internal equity. Regular employees are eligible for short-term and long-term incentives, including cash bonuses and equity opportunities, based on individual, business unit, and company performance.

Benefits

• Medical, dental, vision, and life insurance.
• Fitness and wellness programs, including a fitness reimbursement.
• Short- and long-term disability insurance.
• A minimum of 15 days of paid vacation and an additional end-of-year shutdown (December 26–31).
• Up to 12 company-paid holidays plus 3 paid days off for personal significance.
• 80 hours of sick time per calendar year.
• Paid maternity and parental leave.
• 401(k) program with company-matched contributions.
• Employee stock purchase plan.
• Tuition reimbursement of up to $10,000 per calendar year.
• Participation in Employee Resource Groups.