Clinical Operations Program Lead
About The Position
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 Transplant programs. Reporting to the Head of Clinical 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.
Requirements
- 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.
Nice To Haves
- Previous experience with immune-mediated diseases or transplant clinical programs.
- Expertise in building and scaling clinical operations strategies in a dynamic environment.
Responsibilities
- 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.
Benefits
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Number of Employees
5,001-10,000 employees
