Snr Manager, Feasibility

2 weeks ago

Maidenhead, United Kingdom Biogen Full time
Job Description

About This Role

The Snr Manager, Feasibility will be responsible to conduct research and analysis for pre-study clinical trial feasibility in support of Biogen clinical development efforts; to manage feasibility related processes, metrics, and tracking; to collaborate with CRO partners in support of feasibility related processes; to support Biogen business priorities and initiatives in relation to feasibility and study start-up.

What You’ll Do  

As part of Disease Area, Program, and Study Feasibility Management, this role is responsible for

  1. Feasibility project management
  • Setting timelines for deliverables
  • Gathering SME intelligence/circulating draft feasibility results for stakeholder feedback
  • Holding stakeholders accountable for review deadlines
  • Meeting milestone deadlines for feasibility deliverables.
  1. Knowledge/output management & information handovers
    • Tracking all feasibility related intel and decisions in central location accessible to GCO from Prospective/Pre-Program Feasibility through After-Action Review
    • Ensuring each process stage is completed and information is gathered from/handed to appropriate team members
    • Driving of CRO feasibility work through sharing of Biogen feasibility findings and study specifications (go/no-go countries, preferred sites, enrollment milestone goals, etc.)
  2. Feasibility analysis, intelligence gathering, recommendations, scenario planning, and reporting
    • Conducting data-driven feasibility analysis to support GCO program and study teams in determining the right countries, sites, patients, and timelines
    • Developing and delivering appropriate data and insight packages to program and study teams to support all relevant Governance and planning meetings (e.g, Technical Review Committee, Baseline Forum, Due Diligence/BD related etc.)
    • Engaging with program and study teams to support the build out of various what-if scenarios and modelling for increased transparency on impact to clinical trial operational designs, timelines and operational costs.
    • Investigating clinical subject areas in order to define the scope of clinical trials; researching pertinent scientific/clinical information that may include, but is not limited to: disease background (etiology, epidemiology, statistical information, symptoms, and methods of diagnosis), current standards of care (treatments methods), how the proposed intervention fits into the current treatment landscape, and information regarding competing therapeutics in clinical development. This information is augmented with a critical evaluation of the clinical trial protocol and supporting documents, to proactively identify study strengths and potential risks.
  3. Opportunities to effectively scale and improve processes in support of building valuable data and insight packages for Biogen program and study teams as well as partner CRO counterparts.
  • Acting 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.
  • Developing/tracking KPIs (Effectiveness of internal COE deliverables and assessments provided by CRO, timeliness/completion, etc.)
  1. Continuous evaluation of industry landscape and lead identification & assessment of innovative approaches, platforms, best practices, tools, and systems to meet Biogen’s goal to offer best in class operational feasibility inputs to Biogen’s clinical programs and studies as well as disease area strategies. To support that goal also identify, build, and manage effective relationships with academic, corporate and vendor consortiums. Be a key point of contact and subject matter expert (SME) on Biogen’s existing feasibility related portfolio of platforms, tools and systems.
  2. Depending on business needs, role may be responsible for providing oversight and management of contractor and/or employee staff.

Who You Are

You are a proactive and experienced professional with relevant experience and a good understanding clinical trial feasibility. You are a visionary capable of driving leadership with the ability to work effectively in a dynamic cross-functional environment. A collaborative, innovative mindset with robust communication skills and a proven track record in the pharmaceutical industry.
 


Qualifications

  • Minimum 5-7 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.
  • Bachelor’s degree required, Masters or PhD in associated Drug Development field preferred.
  • Proven track record of providing feasibility related services and value to organization(s).
  • Demonstrated success in working cross-functionally in a global matrix organization.
  • Excellent decision-making skills, communication (oral and written) and presentation skills.
  • Strong organizational skills, including the ability to prioritize needs and handle a high volume of tasks within a given timeframe.


Additional Information

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.

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