Sr Manager, Clinical Trial Lead

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. The role brings value by ensuring operational excellence, proactive issue management, and successful study delivery that advances development program goals. As a core member of Clinical Operations, the CTL partners closely with Medical, Biostatistics, Regulatory, Data Management, and external partners to support broader program and asset strategies.

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.

You thrive in a fast-paced development environment, leveraging your clinical trial management expertise, strategic problem-solving skills, and collaborative leadership style to ensure studies are delivered on time, within budget, and aligned with broader program objectives.

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

This position can be based in either Cambridge, MA or RTP, NC. The pay range posted encompasses the pay range for both potential work locations. Actual pay will be determined by the selected candidate’s work location, as well as relevant experience and qualifications.

Job Level: Management

Additional Information

The base compensation range for this role is: $141,000.00-$188,250.00

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.

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

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