Clinical Operation Program Lead

About This Role

Biogen’s West Coast Hub, based in South San Francisco, is specifically focused on transforming the lives of patients with severe immune-mediated diseases by developing novel targeted therapies with outsized clinical impact, faster. To accomplish this, we are seeking top talent to join us on our journey. The Clinical Operations Program Leader (COPL) plays a pivotal role in leading the strategy, planning, and execution of clinical development program operations for Biogen’s Glomerular Disease (GN) programs. Reporting to the Head of Development Operations, West Coast Hub, the COPL serves as a key program-level representative. In this capacity, you will provide advanced functional and technical expertise, offering strategic insights related to decision points and risks, as well as operational insights such as timeline scenarios, feasibility, and financial considerations. You will drive the development and delivery of high-level clinical study operational strategies aligned with the clinical development plan (CDP) and program objectives, ensuring impactful contributions to Biogen’s overarching goals.

What You’ll Do

• Provide team leadership and line management for clinical trial managers and specialists, fostering best practices within the disease unit.
• Champion career development and performance management for team members.
• Develop operational timeline scenarios, ensuring feasibility and alignment with financial objectives.
• Lead the strategy, planning, and implementation of clinical development program operations across assigned programs.
• Serve as the lead program-level representative, driving recommendations to clinical development plans through strategic and operational insights.
• Oversee program-level clinical operations deliverables, ensuring adherence to timelines, quality standards, and budget expectations.
• Facilitate cross-functional collaboration to achieve clinical program objectives.
• Ensure compliance with GCP, ICH guidelines, and regulatory requirements throughout clinical development activities.

Who You Are

You possess a strategic mindset and deep expertise in program leadership within drug development. Agile and driven, you excel as both an influencer and a team player, thriving in collaborative environments. You are comfortable navigating complexity and enjoy mentoring and guiding teams to achieve their best potential while delivering impactful results.

Required Skills

• B.A. or B.S. in a scientific discipline; advanced degree preferred.
• Scientifically and clinically astute with extensive operational experience and team leadership skills.
• 12+ years of clinical research study and program management experience, including 8+ years managing outsourced clinical trials within sponsor companies.
• Proven ability to oversee multiple studies and programs, with scientific learning agility to address evolving pipelines and external landscapes.
• Deep cross-functional knowledge of drug development and clinical development across various trial phases (Phase I–IV) and therapeutic areas.
• Strong line management experience, with the ability to mentor highly professional staff.
• Exceptional leadership, communication, organizational, and problem-solving skills.
• Thorough knowledge of GCP, ICH guidelines, and regulatory requirements for clinical development.

Preferred Skills

• Previous experience with immune-mediated diseases or glomerular disease clinical programs.
• Expertise in building and scaling clinical operations strategies in a dynamic environment.

Job Level

Management

Additional Information

The base compensation range for this role is: $194,000.00-$267,000.00. 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.

Benefits

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 DE&I efforts.

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.