About This Role
The Associate Director, 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 AD, 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 AD, Feasibility actively engages in continual process improvement initiatives and gathers cross-functional feedback. Depending on business needs, this position may take leadership and/or will participate in initiatives that are at the intersection of technology, process and people. Will be a key contributor and leader for task forces, initiatives, and/or working groups.
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.
- 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/give guidance on initiative project plans and drive large-scale strategic activities forward from beginning to end. Drive task forces and implement initiatives to optimize best practices supporting continuous improvement and other management initiatives. Partner with Director to continue to build Center of Excellence by developing process standards and tools. Lead and support Director with the setting up of the general framework for team including general processes, standing meetings, overarching governance, goals, and/or presentations related to team objectives, etc.
- Continually evaluate industry landscape and lead identification & assessment of innovative approaches. 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. Act as deputy for FCoE Director (e.g., in study governance meetings) and/or act as thought partner for strategic direction of FCoE.
Who You Are
You love analytics and are passionate about using data to drive key business decisions. You are experienced in leading business critical process improvement initiatives. You enjoy mentoring and coaching more junior team members and close collaboration with key stakeholders.
Required Skills
- Minimum 10-12 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.
Additional Information
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 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
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.
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