Sr Manager, Clinical Trial Lead
Biogen
Summary
The Senior Manager, Clinical Trial Lead (CTL) is responsible for leading the operational planning, execution, and delivery of one or more clinical studies across the development lifecycle. This role manages study timelines, budgets, CRO and vendor partnerships, risk mitigation, and cross-functional collaboration through leadership of the Study Management Team (SMT).
Job description
About This Role
The Senior Manager, Clinical Trial Lead (CTL) is responsible for leading the operational planning, execution, and delivery of one or more clinical studies across the development lifecycle. This role manages study timelines, budgets, CRO and vendor partnerships, risk mitigation, and cross-functional collaboration through leadership of the Study Management Team (SMT).
Key objectives include delivering studies on time, within budget, and in compliance with GCP, regulatory requirements, and quality standards while ensuring patient safety and data integrity. Acting as the central operational leader, the CTL drives protocol feasibility, study execution, and informed decision-making across stakeholders.
What You'll Do
- Lead the operational planning, execution, and delivery of one or more clinical studies.
- Chair the Study Management Team (SMT) and drive cross-functional study execution.
- Partner with Medical, Biostatistics, Regulatory, and other stakeholders to develop operationally feasible protocols and study strategies.
- Evaluate study feasibility and develop comprehensive operational, monitoring, quality, and risk management plans.
- Manage study timelines, budgets, forecasts, and governance deliverables to ensure on-time, on-budget execution.
- Identify, assess, and mitigate operational risks while maintaining patient safety, data integrity, and regulatory compliance.
- Oversee CROs, vendors, and outsourced partnerships, ensuring performance, milestone achievement, and effective issue resolution.
- Monitor study performance and conduct ongoing data reviews to identify and address quality, safety, or execution issues.
- Maintain accurate, inspection-ready study documentation and data within clinical trial management systems.
- Champion process improvements, operational excellence, and best practices across studies and development programs.
Who You Are
You are a clinical operations leader who drives the successful planning, execution, and delivery of complex clinical trials, expertly managing timelines, budgets, CRO partnerships, risks, and cross-functional teams while maintaining the highest standards of quality, compliance, patient safety, and data integrity.
Required Skills
- Bachelors degree in a scientific discipline
- 6+ years in clinical operations management, overseeing outsourced clinical trials per quality, timeline, and budget expectations, preferably with a sponsor company and a CRO
- Scientific and clinical expertise with strong project management, risk assessment, contingency planning, and communication skills
- Working knowledge of clinical development across Phase I-IV studies and cross-functional drug development
- Demonstrated experience managing CROs, vendors, and outsourced clinical trials, including governance, performance oversight, budgets, quality, and outsourcing strategies
- Expertise in GCP, ICH guidelines, and global regulatory requirements for clinical development
- Proven ability to develop and execute operational plans that support successful clinical trial delivery
Preferred Skills
- Experience in Immunology, Rare Disease, or Neurology
Requirements
- Bachelors degree in a scientific discipline
- 6+ years in clinical operations management, overseeing outsourced clinical trials
- Scientific and clinical expertise with strong project management, risk assessment, contingency planning, and communication skills
- Working knowledge of clinical development across Phase I-IV studies and cross-functional drug development
- Demonstrated experience managing CROs, vendors, and outsourced clinical trials
- Expertise in GCP, ICH guidelines, and global regulatory requirements for clinical development
- Proven ability to develop and execute operational plans that support successful clinical trial delivery
- Experience in Immunology, Rare Disease, or Neurology (preferred)
Benefits
- Medical, Dental & Vision
- Life Insurance
- Fitness Reimbursement
- Short- & Long-Term Disability
- 15 Days Paid Vacation
- Year-End Shutdown
- 12 Paid Holidays
- Personal Significance Days
- 80 Hours Sick Time
- Paid Maternity & Parental Leave
- 401(k) Matching
- Employee Stock Purchase Plan
- Tuition Reimbursement
- Employee Resource Groups
Company overview
Founded in 1978, Biogen is a leading global biotechnology company headquartered in Cambridge, Massachusetts, specializing in the development and commercialization of innovative therapies for serious neurological and neurodegenerative diseases. As one of the oldest independent biotechnology companies in the United States, Biogen has established itself as a pioneer in neuroscience, focusing on difficult-to-treat conditions where few or no treatment options exist. The company's portfolio includes groundbreaking treatments for multiple sclerosis, spinal muscular atrophy, Alzheimer's disease, ALS, and Friedreich's ataxia. With approximately 7,000 employees worldwide, Biogen operates through a global network that includes research and development hubs in Cambridge, Research Triangle Park in North Carolina, and South San Francisco, along with world-class manufacturing facilities in the United States and Switzerland. The company's commitment to scientific innovation is demonstrated by its Nobel Prize-winning founders and its receipt of the U.S. National Medal of Technology and Innovation. Biogen's patient-centric approach drives its mission to deliver transformative medicines that improve lives while creating sustainable value for shareholders and communities.