Sr Manager, Clinical Trial Lead

• 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.

• 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.

• 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
• 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