Biogen is seeking a Clinical Operations Program Lead (COPL) to join our West Coast Hub in South San Francisco, focused on advancing therapies for severe immune-mediated diseases. In this remote role, the COPL will be instrumental in shaping the strategy, planning, and execution of clinical development operations for our Glomerular Disease programs. Reporting to the Head of Development Operations, you will act as a vital program-level representative, leveraging your functional and technical expertise to provide strategic insights on decision-making and risk management. You will also offer operational perspectives on timelines, feasibility, and financial implications, ensuring the effective development and execution of clinical study operational strategies. This position presents an opportunity to significantly impact patient outcomes through innovative therapeutic approaches.
| At-a-Glance | |
|---|---|
| Location | Remote (US) |
| Salary | TBD |
| Closing Date | 1 Sep 2025 |
| Discipline | Biomedicine , Life Science |
| Job Type | Manager |
| Duration | Permanent |
| Hours | Full time |
| Sector | Industry |
| Qualification | Undergraduate |
| Website | Visit |
Biogen is seeking a Clinical Operations Program Lead (COPL) for its West Coast Hub, located in South San Francisco, to spearhead the strategic planning and execution of clinical development operations for its Glomerular Disease (GN) programs. This position is integral to Biogen’s mission of transforming the lives of patients with severe immune-mediated diseases through innovative, targeted therapies. The COPL will report directly to the Head of Development Operations and will serve as a key representative at the program level, providing critical insights and leadership throughout the clinical trial process.
In this role, the COPL will leverage advanced functional and technical expertise to inform decision-making related to program risks and operational efficiencies. This includes developing comprehensive operational timeline scenarios that align with financial objectives and clinical development plans (CDPs). The COPL will be responsible for leading a team of clinical trial managers and specialists, fostering a culture of best practices and continuous improvement within the disease unit. Career development and performance management for team members will also be a priority, ensuring that the team is well-equipped to meet Biogen’s ambitious goals.
The COPL will oversee program-level clinical operations deliverables, ensuring compliance with Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, and other regulatory requirements. By facilitating cross-functional collaboration, the COPL will drive the execution of clinical study operational strategies that align with Biogen’s overarching objectives. The ideal candidate will possess a strategic mindset, deep expertise in drug development, and a proven ability to navigate complex challenges while mentoring teams to achieve impactful results.
Overall, the Clinical Operations Program Lead at Biogen plays a crucial role in advancing clinical research and ensuring the successful delivery of innovative therapies that can significantly improve patient outcomes.
Responsibilities
- Oversee clinical trial design and implementation, ensuring alignment with regulatory requirements and organizational goals.
- Collaborate with cross-functional teams to develop and execute clinical program strategies and timelines.
- Monitor trial progress, analyzing data to ensure compliance and address any emerging issues promptly.
- Manage vendor relationships, including selection, oversight, and performance evaluation for clinical operations.
- Prepare and present reports on clinical trial status, findings, and recommendations to stakeholders.
- Ensure adherence to budgetary constraints while optimizing resource allocation across clinical programs.
Qualifications
- Advanced degree in life sciences, healthcare, or related field.
- Proven experience in clinical operations and project management.
- Strong knowledge of regulatory requirements and clinical trial processes.
- Excellent leadership and team management skills.
- Effective communication and interpersonal abilities.
- Proficient in data analysis and clinical trial software tools.
Benefits
- Oversees clinical trial execution, ensuring adherence to timelines and regulatory standards.
- Enhances team collaboration, fostering a culture of innovation and continuous improvement.
- Drives data-driven decision-making, optimizing resource allocation and project outcomes.
- Facilitates stakeholder communication, ensuring alignment and transparency throughout the clinical program.
