Sr Manager, Clinical Trial Lead

Biogen, Inc.; Cambridge (MA); On-site; USD 141,000 - 188,000; Full time

Benefits offered by this job

Medical, Dental, Vision, & Life ins.

Fitness & Wellness programs

Short- and Long-Term Disability

Paid vacation and year-end shutdown

Paid holidays and personal days

Sick time

Parental Leave

401(k) with company match

Employee stock purchase plan

Tuition reimbursement

Employee Resource Groups

Job summary

Biogen, Inc. is seeking a Senior Manager, Clinical Trial Lead to own operational planning, execution, and delivery of complex clinical studies.

You will lead the SMT, coordinate with Medical, Biostatistics, Regulatory, and Data Management, and drive strategy that ensures timelines, budgets, and patient safety are upheld. The role requires deep experience in clinical operations, governance of CROs and vendors, and a strong track record of delivering trial milestones in compliance with GCP and

Qualifications

• Bachelor's degree in a scientific discipline.
• 6+ years in clinical operations management.
• Experience overseeing outsourced trials with adherence to timelines, budgets, and quality.
• GCP, ICH guidelines, and global regulatory requirements knowledge.
• Proven ability to develop operational plans and manage CRO/vendor partnerships.

Responsibilities

• Lead 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 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.

Skills

Project management

Risk assessment

Contingency planning

Communication skills

GCP

ICH guidelines

Regulatory knowledge

Vendor management

Education

Bachelor's degree in a scientific discipline

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. 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.

• 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

Why Biogen? We are a global team with a commitment to excellence, and a pioneering spirit. As a mid‑sized biotechnology company, we provide the stability and resources of a well‑established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life‑changing medicines, with every role playing a vital part in our mission.

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid‑sized biotechnology company, we provide the stability and resources of a well‑established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life‑changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives. At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about Biogen. All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.

As Biogen recently acquired Apellis, you can find additional open jobs on our Apellis website here.