Director, Clinical Operations Program Leadership (COPL)

Biogen

1d•$198,000 - $272,250

About The Position

The Director, Clinical Operations Program Leadership (COPL) leads the strategy, planning, and implementation of clinical development program operations in the Clinical Trial Delivery Unit of the Quantitative Science Development Operations organization. As the lead program-level QSDO representative to the Development Asset Team and, when called upon, the Product Development and Commercialization team, this person contributes strategic and operational expertise to Integrated Asset Plans, clinical development plans, and other initiatives that advance Biogen clinical programs. The COPL is accountable for program-level clinical operations strategy, planning, oversight, and delivery, including developing a high-level operational strategy aligned with the clinical development plan and program objectives and bringing the operational perspective to governance meetings and presentations. The COPL serves as the program champion and coordination hub within QSDO. The role develops and oversees operational strategy across the program lifecycle, considering technical, vendor, quality, site and investigator, geographic, and patient-centric factors. The COPL facilitates communication between the Development Asset Team and QSDO, provides direction, incorporates risk management, and supports resolution of technical issues. The role may cover one highly complex program, multiple medium-complexity programs, and/or programs involving external collaborators. The Director leads development and refinement of program study timelines and scenarios, provides objective status updates and aligned QSDO recommendations, and oversees delivery of clinical studies to quality, ethical, cost, timeline, and recruitment objectives. The role leads COPL contributions to governance presentations and memos, communicates key messages and risks to senior and executive leaders, and aligns governance materials with QSDO and Clinical Trial Delivery Unit leadership. The COPL proactively engages Biogen and partner stakeholders, escalates CRO, FSP, and vendor delivery issues, and drives risk mitigation to protect program timelines. The role also develops and executes a QSDO Program Operational Plan that reflects the therapeutic area, underlying science, opportunities for innovation and consistency, and the molecule’s future clinical, regulatory, and commercial development. The plan is cascaded across QSDO functions to establish a strategic framework for study-level delivery. The COPL may contribute to due diligence and business evaluations, including external clinical development plan reviews, internal timeline and scenario development, capability assessments, recommendations, and QSDO resource planning for potential clinical candidates.

Requirements

Undergraduate degree in a scientific or health-related discipline.
At least 12 years of experience in a biotech or pharmaceutical environment in drug development, clinical research, and operational strategy, including execution of studies and programs to quality, timeline, and budget objectives.
At least 3 years of experience in a biotech or pharmaceutical program operational delivery capacity.
Project or program management skills, including risk assessment and mitigation identification, timeline and budget management, and contingency planning.
Effective team leadership and ability to influence matrix teams.
Strong communication, time management, organizational, problem-solving, conflict-resolution, and team-building skills.
Experience identifying and leveraging relevant data and information to develop well-conceived, executable timelines.
Experience across several complex therapeutic areas and the ability to learn and apply relevant disease information to strategic operational planning and delivery.
Deep operational expertise and experience planning and delivering global clinical programs and studies through all stages of development, Phases 1–4, and lifecycle management.

Nice To Haves

Advanced scientific or business degree, or equivalent experience (MS, PhD, PharmD, MBA, or MPH).
Experience facilitating development of Clinical Development Plans with multiple functions.

Responsibilities

Lead the development and ongoing refinement of program-level study timelines and scenarios to inform the Integrated Asset Plan and other strategic plans.
Provide objective program status updates and aligned QSDO recommendations to the Development Asset Team to support strategic decisions.
Take overall accountability for QSDO delivery of clinical studies within assigned programs and oversee quality, ethical, cost-efficient execution against approved timelines and patient recruitment goals.
Lead COPL input and development of governance presentations and memos, integrating the operational perspective and communicating key messages and risks to senior and executive leaders.
Reach technical alignment on governance materials with the Head of QSDO and Head of CTDU within governance timelines.
Engage Biogen and partner stakeholders, including CROs and vendors, and use QSDO governance to support clinical program execution.
Escalate CRO, FSP, and vendor delivery issues to senior vendor-partner leadership and drive risk mitigation strategies to maintain program timelines.
Develop and execute a QSDO Program Operational Plan that reflects therapeutic area, scientific, innovation, operational consistency, and future development needs.
Cascade the Program Operational Plan within QSDO to relevant sub-functions to establish a strategic framework for successful study-level delivery.
Facilitate communication between the Development Asset Team and QSDO, provide direction, incorporate risk management, and support resolution of technical issues.
Potentially contribute to due diligence and business evaluations, including reviews of external development plans and capabilities, timeline scenarios, recommendations, and resource plans.

Benefits

Medical, dental, vision, and life insurance
Fitness and wellness programs, including fitness reimbursement
Short- and long-term disability insurance
At least 15 days of paid vacation and end-of-year shutdown time off from December 26 through December 31
Up to 12 company-paid holidays and 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 up to $10,000 per calendar year
Employee Resource Groups participation
Short-term and long-term incentives, including cash bonus and equity incentive opportunities