Sr Manager, Clinical Trial Lead

Job Description

This position can be located in either our Cambridge, MA or Research Triangle Park, NC offices

As a Sr Manager, Clinical Trial Lead, you will partner with Medical Research and other functions to develop operationally feasible and clear protocol concepts and final protocols. You will leverage phase and operational expertise to establish study level operational strategy and alignment with the Clinical Development Plan (CDP) and program level strategy.

You will also independently oversee one or more clinical studies by establishing the operational strategy and securing excellence in execution through the CRO partner.

1. 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

2. 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.)

3. Strives for effective, consistent, efficient, and compliant processes

• Champions best practices and seeks opportunities for innovation and efficiency within COSL 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 COSL group and actively promotes interaction with other Biogen groups
• Promotes a rich and diverse knowledge base within COSL, contributing SME expertise where applicable

Qualifications

• B.A. or B.Sc. in a scientific discipline; advanced degree preferred.
• 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.
• Scientifically and clinically astute with very strong project management and communications skills
• Deep understanding of clinical development within one or more Phases of trials (Phase I, II, III, IV) and a working understanding of cross functional drug development.
• Thorough knowledge of GCP, ICH guidelines and regulatory requirements for clinical development.
• Ability to establish operational plans and support the CRO in the execution of the plans.
• Effective prior CRO management skills and be able to adapt to the GCO outsourcing model.
• Excellent project management skills, including risk assessment and contingency planning.
• Abilityto partner with other functions and both internal and external stakeholders.

• Prior investigator site and/or monitoring experience

Additional Information

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.

All your information will be kept confidential according to EEO guidelines.

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