New · posted Nov 1
Biogen · Biotechnology
Sr Manager, Clinical Trial Lead
- Cambridge, MA +1 more
- On-site
- Full-time
- Manager
The 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 need
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.
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.
Preferred Skillsnice to have
- 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
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.
Pay and benefits
$141,000 – $188,250 a year
Employer providedAdditional 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
Medical, dental, vision and life insurance
401(k) with company match
Employee stock purchase plan
Cash bonus and equity incentives
Paid vacation, holidays and sick time
Tuition reimbursement up to $10,000 per year
Where you'll work
Cambridge, MA +1 moreOn-siteOpen in Maps (opens in a new tab)
Also posted for: Research Triangle Park, NC
More jobs in Cambridge, MA +1 more
From the posting
About Biogen
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.
Equal opportunity, accessibility and legal noticesBiogen's statements, word for word
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.
Job intelligence
The context around this role
Live data · November 1, 2026
Salary intelligence
How the pay compares
This role's midpoint is 1% above the US median for Clinical Trial Management roles at this level.
This roleEmployer provided
Manager roles in Massachusetts9 roles publishing pay
Manager roles in the US44 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $141,000 | — | $188,250 |
| Massachusetts (middle half) | $149,000 | $175,000 | $177,000 |
| All US (middle half) | $150,125 | $163,000 | $175,000 |
This role: Biogen's own published range. Comparisons: the base pay employers published on open Clinical Trial Management roles at the same level on Regulatory Jobs, November 1, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Trial Management
The general path across 69 open Clinical Trial Management roles on Regulatory Jobs, with the titles they carry most. Not Biogen's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 23 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Clinical trial conduct12
- Collaboration and leadership8
- GMP and compliance5
- Quality systems and risk3
- Data and digital systems3
- Documentation and SOPs2
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- ICHICH quality guidelines(official source, opens in a new tab)Q1 stability, Q2(R2) analytical validation, Q7, Q9 risk management, Q10 quality systems
- ICHICH E6 good clinical practice(official source, opens in a new tab)The international standard for the conduct of clinical trials
Company hiring pulse
Biogen on Regulatory Jobs
- 23
- Open roles
- 23
- Distinct roles
- 4
- Locations
By discipline
- Clinical12 52%
- Quality7 30%
- Regulatory4 17%
By level
- Director7 30%
- Senior & Principal7 30%
- VP & Executive4 17%
More roles at Biogen
- View role
Clinical Trial Manager, Class III Medical Devices
Remote, USManagerMedical Devices$117K–$157K
- View role
Associate Medical Director, Global Safety Physician
Remote, USDirectorBiotechnology$184K–$253K
- View role
Associate Director Clinical Development, Immunology
Remote, USDirectorBiotechnology$184K–$253K
- View role
Sr Clinical Data Manager, WCH
Remote, USSenior & PrincipalBiotechnology$93K–$121K
Similar Clinical Trial Management roles elsewhere
- View role
Senior Clinical Trial Manager
Stoke TherapeuticsBedford, MA · HybridManagerBiotechnologySalary not listed
- View role
Senior Clinical Trial Manager
Rapport TherapeuticsBoston, MA · HybridManagerBiotechnology$165K–$185K
- View role
Senior Clinical Trial Manager
MBX BiosciencesBurlington, MA · HybridManagerBiotechnologySalary not listed
- View role
Senior Clinical Trial Manager
Kymera TherapeuticsWatertown, MAManagerBiotechnology$145K–$215K
Sr Manager, Clinical Trial Lead at Biogen
Open until filled. $141K–$188K a year, employer provided.