Sr Manager, Clinical Trial Lead

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

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

Wellness Programs

Vacation and holidays

401(k) plan

Employee stock purchase plan

Tuition reimbursement

Job summary

Biogen is seeking a Senior Manager, Clinical Trial Lead to spearhead planning, execution, and delivery of clinical studies across development. You will chair SMT, manage CROs, budgets, and timelines while aligning with GCP and regulatory standards for patient safety and data integrity.

You will collaborate with Medical, Biostatistics, Regulatory, and Data Management to optimize protocols and study strategies, driving operational excellence across programs.

Qualifications

• Bachelors degree in a scientific discipline required.
• 5+ years of clinical operations management experience in outsourced trials preferred.
• Strong project management, risk assessment, contingency planning, and communication skills.
• Experience across Phase I–IV trials and cross-functional development.
• Proven ability to manage CROs, vendors, budgets, quality, and outsourcing strategies.
• Knowledge of GCP, ICH, and global regulatory requirements for clinical development.

Responsibilities

• Lead the planning, execution, and delivery of one or more clinical studies.
• Chair the Study Management Team and drive cross-functional study execution.
• Partner with Medical, Biostatistics, Regulatory, and other stakeholders to develop operational protocols.
• Evaluate feasibility and develop operational, monitoring, quality, and risk plans.
• Manage study timelines, budgets, forecasts, and governance deliverables.
• Oversee CROs, vendors, and outsourced partnerships, ensuring performance and issue resolution.

Skills

Project management

Risk assessment

Cross-functional collaboration

Communication

GCP knowledge

ICH guidelines

Education

Bachelor's degree in a scientific discipline

Tools

CTMS

Job description

About This RoleThe 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 SkillsBachelors degree in a scientific discipline6 + years in clinical operations management, overseeing outsourced clinical trials per quality, timeline, and budget expectations, preferably with a sponsor company and a CROScientific 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 SkillsExperience in Immunology, Rare Disease, or NeurologyThis 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: ManagementAdditional InformationThe base compensation range for this role is: $141,000.00-$188,250.00Base 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 insurancesFitness & Wellness programs including a fitness reimbursementShort- and Long-Term Disability insuranceA 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 Significance80 hours of sick time per calendar yearPaid Maternity and Parental Leave benefit401(k) program participation with company matched contributionsEmployee stock purchase planTuition reimbursement of up to $10,000 per calendar yearEmployee Resource Groups participationWhy 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.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.