Director, Clinical Operations Program Leadership (COPL)

Regulatory Jobs; North Carolina; On-site; USD 198,000 - 272,000; Full time

Benefits offered by this job

Medical, Dental, Vision insurance

401(k) plan with company match

Employee stock purchase plan

Paid time off & holidays

Job summary

Biogen seeks a Director, Clinical Operations Program Leadership (COPL) to strategize and execute program-level clinical operations within the QSDO. This role influences Integrated Asset Plans and governance decisions, aligning operational voice with senior leadership.

You will guide timelines, risk management, and cross-functional collaboration with DAT, PDC, CROs, and vendors to ensure timely, compliant delivery across Ph1–Ph4 and potential LCM stages.

Qualifications

• Undergraduate degree in a scientific or health-related discipline; advanced degree preferred.
• 12+ years in Biotech/Pharma with drug development, clinical research and operational strategy, with at least 3 years in a Delivery capacity.
• Demonstration of project/program management skills including risk assessment, timelines, budgets and contingencies.
• Demonstration of effective team leadership and ability to influence matrix teams; excellent communication and problem-solving skills.
• Experience delivering global clinical programs across Ph1-4 and lifecycle management.

Responsibilities

• Leads development of program-level study timelines and scenarios to contribute to IAP and other strategic plans.
• Provide rigorous, objective information and aligned QSDO recommendations to DAT for strategic decisions.
• Owns QSDO delivery of clinical studies within a program, ensuring high quality, cost-efficient timelines and recruitment goals.
• Lead governance materials and presentations, communicating risks to senior leaders.
• Engage with Biogen and partners (CROs, vendors) to support execution and mitigate risks to timelines.
• Develop and execute a QSDO Program Operational Plan (POP) aligned to therapeutic area and science.

Skills

Project management

Team leadership

Communication

Time management

organizational skills

Data-driven timelines

Therapeutic domain knowledge

Operational expertise

CDP development

Education

Undergraduate degree in science/health

Advanced degree preferred (MS/PhD/PharmD/MBA/MPH)

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 and contingency planning.

• Demonstration of effective team leadership and an ability to effectively influence matrix teams. Excellent communication, time 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 through all stages of development Ph 1-4 and LCM.

• Experience facilitating the development of Clinical Development Plans (CDPs) with multiple functions strongly desired.

Job Level: Management

Additional Information

The base compensation range for this role is: $198,000.00-$272,250.00

Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.

Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.

In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being; including, but not limited to:

• Medical, Dental, Vision, & Life insurances
• Fitness & 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 time off (Dec 26-Dec 31)
• Up to 12 company paid holidays + 3 paid days off for Personal Significance
• 80 hours of sick time per calendar year
• Paid Maternity and Parental Leave benefit
• 401(k) program participation with company matched contributions
• Employee stock purchase plan
• Tuition reimbursement of up to $10,000 per calendar year
• Employee Resource Groups participation

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our Biogen.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.