Biogen · 8 hours ago
Sr. Manager, Clinical Trial Lead
United States
Full-time
Remote
Senior Level
$131K/yr - $175K/yr
6+ years expBiogen is a biotechnology company focused on transforming the lives of patients with severe immune-mediated diseases. They are seeking a Senior Manager, Clinical Trial Lead to oversee clinical studies, develop operational strategies, and collaborate with cross-functional teams to ensure successful study delivery.
BiotechnologyHealth CareNeuroscienceTherapeutics
Responsibilities
Develops and oversees implementation of the study-level operational strategy for the successful delivery of clinical study(ies)
Chairs the SMT to drive the development of scientifically robust, operationally feasible, and clear protocol concepts/protocols
Collaborates strategically with the core SMT (study MD, biostatistics, etc.) and other key program team members to provide direction on phase, disease, or therapeutic area to support study design in alignment with the Integrated Development Plan and Global Program Strategy, enabling protocol concept development and driving forward studies through governance approval
Leverages operational expertise and scientific assessment to evaluate study feasibility and support protocol development
Aligns team perspectives to develop a cross-functional operational strategy, leveraging expertise, current therapeutic knowledge, and relevant supporting data
Effectively leads the study via oversight of the CRO, managing performance, quality, and timelines, including defining and delivering against a baseline plan
Ensures ongoing data review to identify and mitigate patient safety, study design, data integrity or study conduct issues
Exhibit financial management & analysis skills to ensure budgets hold up to appropriate scrutiny and align with study endpoint needs
Oversees the delivery of studies by CROs, ensuring quality execution in line with time and budget forecasts
Chairs the Study Management Team (SMT) in partnership with the CRO SMT Lead; ensures the CRO creates appropriate risk mitigation plans and is effective in proactively identifying and resolving issues
Establishes and drives effective and efficient team operations by setting culture of SMT, ensuring thorough team communication, effective goal setting/management and oversight of strategy implementation
Ensures all operational aspects of the study(ies) conduct support patient safety, endpoint integrity and data validity
Demonstrates a robust understanding of the study design, rationale, endpoints, and patient population
Provides oversight via ongoing review of performance and partnership metrics to ensure key milestones and deliverables are achieved
Ensures that all project plans (e.g. Monitoring Plan, Quality Plan, etc.) are in place for effective implementation of studies
Leads SMT to develop robust Baseline plans, and ensures team is thoroughly prepared for all key governance forums including but not limited to, Baseline, Study Delivery forum, etc
Proactively & robustly manages inflection points to ensure any necessary course correction is proactively addressed
Collaborates with CFP and procurement functions to ensure FMV is achieved and budget oversight responsibilities are met
Maintains data accuracy, completeness and quality within study-related systems (e.g. Clarity, Impact, etc.)
Strives for effective, consistent, efficient, and compliant processes
Champions best practices and seeks opportunities for innovation and efficiency within CTDU and GCO
Seeks synergies and commonalities with other studies, programs, and development units to enhance excellence in study planning and execution
Seeks ways to improve and streamline processes to support the GCO CRO outsourcing models; provides feedback via appropriate channels for opportunities to improve processes or establish best practices
Embodies a culture of continuous improvement by seeking consistency and efficiency in processes and fully supporting the CRO partnership model
Advocates for the CTDU group and actively promotes interaction with other Biogen groups
Promotes a rich and diverse knowledge base within CTDU, contributing SME expertise where applicable
Qualification
Required
B.A. or B.Sc. in a scientific discipline
Scientifically and clinically astute with very strong project management and communications skills
Approximately 6 -8 years of clinical operations Clinical Trial/Project Management experience, preferably with both a sponsor company and CRO company, managing outsourced clinical trials within quality, timeline, and budget expectations. Prior investigator site and/or monitoring experience is advantageous
Preferred
Advanced degree
Sponsor and/or CRO Global trial management experience
Investigator site and/or monitoring experience
Benefits
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
Company
Biogen
Biogen is an American biotechnology company that provides therapeutics for neurological, autoimmune, and rare diseases.
Founded in 1978Cambridge, Massachusetts, USA
5001-10000 employees
H1B Sponsorship
Biogen has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (100)
2024 (93)
2023 (101)
2022 (134)
2021 (104)
2020 (114)
Funding
Current Stage
Public CompanyTotal Funding
$1.5BKey Investors
JP Morgan
2023-08-28Post Ipo Debt· $1.5B
1991-09-27IPO
Leadership Team
Robin C. Kramer
Executive Vice President, Chief Financial Officer
Priya Singhal
Executive Vice President, Head of Development
Recent News
San Diego Union-Tribune
2026-02-04
Company data provided by crunchbase