About This Role:
The Senior Manager, Feasibility is a member of the Feasibility Center of Excellence (FCoE), supporting data-driven study operational planning and protocol simplification, accelerating study start-up activities, and harmonizing processes to ensure study teams meet and exceed target program timelines. The Sr. Mgr., Feasibility advances this effort through the development of program and study level feasibility assessments, robust country and site analysis, data-driven protocol assessments, and enrollment forecasts across all phases of development. The Sr. Mgr., Feasibility actively engages in continual process improvement initiatives and gathers cross-functional feedback.
This is a hybrid role, with 50% of each week to be spent on site at our offices in Maidenhead.
What You’ll Do :
Develop and deliver appropriate data and insight packages to program and study teams to support all relevant governance and planning meetings (E.g., Baseline Forum, due diligence/BD, etc.). Engage with program and study teams to support the build out of various what-if scenarios and enrollment modelling for increased transparency on impact to clinical trial operational designs, timelines and operational costs.
Conduct research and analysis for pre-study clinical trial feasibility in support of Biogen clinical development efforts; manage feasibility related processes, metrics, and tracking; support Biogen business priorities and initiatives in relation to feasibility and study start-up.
Deliver critical, data-driven evaluation of the clinical trial protocol and supporting documents, to proactively identify study strengths and potential risks.
Identify opportunities to effectively scale and improve processes in support of continuous innovation. Identify, monitor, analyze and appropriately act on key quality and performance indicators for process oversight/adherence, and measure of success to ensure maximum impact and efficiency in overall feasibility processes and output. Develop/track KPIs (Effectiveness of internal COE deliverables and assessments provided by CRO, timeliness/completion, etc.)
Mentor/support team members and participate in initiatives to optimize best practices supporting continuous improvement and other management initiatives.
Continually evaluate industry landscape and lead identification & assessment of innovative approaches. Be a key point of contact and subject matter expert (SME) on Biogen’s existing feasibility related portfolio of platforms, tools and systems.
Who You Are:
You are an experienced clinical research professional. You love analytics and are passionate about using data to drive key business decisions. You are experienced in supporting business critical process improvement initiatives. You enjoy mentoring and coaching more junior team members and close collaboration with key stakeholders.
Required Skills:
Bachelors Degree in a Life Science Field required, Masters degree preferred
Significant years of biotech, pharmaceutical or CRO clinical operations experience in either study feasibility, and/or study design optimization and/or clinical operations project management at a global level.
Proven experience in data analysis and interpretation to inform strategic decision making, project management, developing study delivery strategies and tactical operational plans aligned to the commercial and regulatory objectives. Deep analytical and or AI skills an advantage.
Strong understanding of all aspects of clinical drug development, with particular emphasis on clinical trial design, trial execution, and strong knowledge about the feasibility and planning process of a program and/or study.
Preferred Skills:
Experience project managing end-to-end initiatives and workstreams, preferably with experience in PM methodologies such as Six Sigma, Agile, etc.
Excellent stakeholder management, concise written communication, ability to influence, clearly communicate and collaborate across complex matrix environment.
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.
