Sr. Manager - Clinical Trial Lead

Biogen•Cambridge, MA

About The Position

About This Role The Senior Manager, CTL, leverages their phase, indication and operational expertise to independently manage and ensure delivery of one or more clinical studies, including: • Partnering with cross-functional representatives to drive the development of operationally feasible and robust protocol designs, ensuring that principles of patient focus, risk management, quality and scientific integrity are applied, exercising appropriate budget responsibility and focused, endpoint-driven cost consideration. • Developing and implementing the study-level operational plans, cascading key operational aspects from the Integrated Asset Plan (IAP) and Program Operational Plan (POP) to support delivery of protocol. • Responsible for day-to-day study management, applying competency and experience-based knowledge to ensure the successful delivery of these supportive studies. • Manages study execution activities, ensuring GCP compliance, tracking milestones and resolving operational risks. • As a core member of the Study Management Team, leverages available data to help SMTs make informed decisions, securing excellence in execution and alignment with agreed strategy and associated plans. • Supports the development of comprehensive clinical trial budgets that accurately reflect the costs of all trial activities, including patient care, research procedures, and administrative expenses. What You’ll Do: Support the development and executes study-level operations 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. · As required, 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 Asset Plan (IAP) and Program Operational Plan (POP), 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 support the development of cross-functional operational plans, leveraging expertise, current therapeutic knowledge, and relevant supporting data. · Supports the day-to-day study operations by building a strong team and fostering a collaborative environment, including clear communications, proactive risk identification and mitigation, and ensuring compliance with the study protocol, GCP and regulatory guidelines. · Participate in ongoing data review to identify and mitigate patient safety, study design, data integrity or study conduct issues. · Responsible for developing study budgets that hold up to appropriate scrutiny and align with study endpoint needs. Responsible for study delivery, ensuring successful execution in line with time and budget forecasts · 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. · Performs ongoing review of study performance for outsourced studies, review partnership metrics to ensure key milestones and deliverables are achieved. · Responsible for the development of all project related plans (e.g. Project Management Plan, Monitoring Plan, Study Risk Management Plan, etc.) for effective implementation of studies. · Ensure 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, ensuring required information 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 Procurement to ensure FMV transparency, regularly monitoring the budget to identify potential overspending and addressing specific cost drivers. · Maintains data accuracy, completeness and quality within study-related systems (e.g. Planisware, Veeva CTMS, Beacon, etc.). · For outsourced studies they lead, 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. Strives for effective, consistent, efficient, and compliant processes · Champions best practices and seek opportunities for innovation and efficiency · 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 department clinical trial outsourcing models; provides feedback via appropriate channels for opportunities to improve processes or establish best practices. · Advocates for the department and actively promotes interaction with other Biogen groups. · Promotes a rich and diverse knowledge base, contributing SME expertise where applicable.

Requirements

B.A. or B. Sc. 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
Related scientific and clinical expertise and exceptional project-management, risk-assessment, contingency-planning, and communication skills
Working knowledge of clinical development related to one or more trial phases (I, II, III, or IV), as well as cross-functional drug development
Expertise in Good Clinical Practices (GCP), International Council for Harmonization (ICH) guidelines and regulatory requirements for clinical development
Ability to develop and execute operational plans in support of clinical trial delivery
Effective CRO management skills and ability to adapt to fit for purpose clinical trial outsourcing strategies and models
Working knowledge of the financial aspects of clinical trials including budgeting, financial management, reporting, and analysis

Responsibilities

Support the development and executes study-level operations 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.
As required, 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 Asset Plan (IAP) and Program Operational Plan (POP), 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 support the development of cross-functional operational plans, leveraging expertise, current therapeutic knowledge, and relevant supporting data.
Supports the day-to-day study operations by building a strong team and fostering a collaborative environment, including clear communications, proactive risk identification and mitigation, and ensuring compliance with the study protocol, GCP and regulatory guidelines.
Participate in ongoing data review to identify and mitigate patient safety, study design, data integrity or study conduct issues.
Responsible for developing study budgets that hold up to appropriate scrutiny and align with study endpoint needs.
Responsible for study delivery, ensuring successful execution in line with time and budget forecasts
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.
Performs ongoing review of study performance for outsourced studies, review partnership metrics to ensure key milestones and deliverables are achieved.
Responsible for the development of all project related plans (e.g. Project Management Plan, Monitoring Plan, Study Risk Management Plan, etc.) for effective implementation of studies.
Ensure 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, ensuring required information 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 Procurement to ensure FMV transparency, regularly monitoring the budget to identify potential overspending and addressing specific cost drivers.
Maintains data accuracy, completeness and quality within study-related systems (e.g. Planisware, Veeva CTMS, Beacon, etc.).
For outsourced studies they lead, 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.
Strives for effective, consistent, efficient, and compliant processes
Champions best practices and seek opportunities for innovation and efficiency
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 department clinical trial outsourcing models; provides feedback via appropriate channels for opportunities to improve processes or establish best practices.
Advocates for the department and actively promotes interaction with other Biogen groups.
Promotes a rich and diverse knowledge base, contributing SME expertise where applicable.

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