Biogen’s West Coast Hub, based in South San Francisco, is specifically focused on transforming the lives of patients with severe immune-mediated diseases by developing novel targeted therapies with outsized clinical impact, faster. To accomplish this, we are seeking top talent to join us on our journey. 

In alignment with established procedures and SOPs, the Senior Manager, CTL, leverages their phase, indication and operational expertise to independently oversee 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 strategy, cascading key operational aspects from the Integrated Development Plan and Global Program Strategy to support delivery of protocol    

Performing high-level data driven oversight of Biogen’s CRO partners, securing excellence in execution and alignment with agreed strategy and associated plans   

What You’ll Do

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   

Who You Are 

Scientifically and clinically astute, you’re a mission-driven individual with the strategic vision to see the big picture and assume responsibilities much broader and more meaningful than day-to-day operations. Decisive, analytical and self-confident, you are determined to own all of your career and the difference you can make on the lives of others through your leadership and ability to inspire excellence. 

Required Skills & Experience  

B.A. or B.Sc. in a scientific disciplineScientifically 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 Experience 

Advanced degree

Sponsor and/or CRO Global trial management experience 

Investigator site and/or monitoring experience 

 

Job Level: Management

Additional Information

The base compensation range for this role is: $131,000.00-$175,000.00

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 insurancesFitness & Wellness programs including a fitness reimbursement Short- 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 Significance 80 hours of sick time per calendar yearPaid Maternity and Parental Leave benefit 401(k) program participation with company matched contributionsEmployee stock purchase plan Tuition reimbursement of up to $10,000 per calendar year Employee Resource Groups participation

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 our DE&I efforts.

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.