Associate Director of Clinical Operations Program Leadership

About This Role:

As the Associate Director of Clinical Operations Program Leadership, you will be a pivotal force in guiding the strategy, planning, and execution of clinical development program operations within the Quantitative Science & Development Operations (QSDO) organization. This role involves serving as the lead program-level QSDO representative to the Development Asset Team and occasionally to the Product Development and Commercialization Team. You will contribute your advanced functional and technical expertise, offering strategic and operational insights to enhance Integrated Asset Plans, clinical development plans, and other critical initiatives. In this capacity, you will oversee the delivery of program-level clinical operations deliverables, developing high-level operational strategies aligned with program objectives. Your role as the program champion will ensure cohesive communication and strategic implementation across various stakeholders, including technical, vendor, and patient-centric considerations. You will be responsible for program lifecycle management, facilitating communication between the DAT and QSDO, and ensuring resolution of technical issues. This position may include oversight of one or more clinical programs ranging from low to medium complexity.

What You’ll Do:

• Lead the development and refinement of program-level study timelines and scenarios for strategic planning.
• Provide objective information and aligned QSDO recommendations to support strategic project decisions.
• Take accountability for QSDO delivery of clinical studies, ensuring high-quality, ethical, and cost-efficient execution.
• Develop governance presentations and memos, communicating key messages and risks to senior leaders.
• Engage proactively with stakeholders, leveraging governance frameworks for clinical program execution.
• Escalate vendor delivery issues to senior leadership, driving risk mitigation strategies.
• Develop and execute a QSDO Program Operational Plan, integrating stage-appropriate needs into operational strategy.
• Participate in due diligence/business evaluations, reviewing external CDP strategies and developing internal timelines.

Who You Are: You are a strategic thinker with a knack for operational excellence. Your ability to lead matrix teams and communicate effectively makes you an essential asset to any team. You are agile and adaptable, capable of integrating complex scientific and clinical insights into operational strategies. Your proactive approach to problem-solving and conflict resolution ensures that you navigate challenges with ease. Your deep operational expertise and experience in global program delivery make you a trusted leader in the field.

Required Skills:

• Experience in drug development, clinical research, and operational strategy.
• Demonstrated project/program management skills including risk assessment and contingency planning.
• Effective team leadership skills with excellent communication and organizational skills.
• Experience in developing and executing timelines based on relevant data.
• Experience across complex therapeutic areas, with scientific and clinical agility.
• Deep operational expertise in planning and delivering global clinical programs.

Preferred Skills:

• Advanced scientific or business degree (MS/PhD/PharmD/MBA/MPH).
• Experience in facilitating Clinical Development Plans with multiple functions.

 

Job Level: Management

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 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.