Biogen
Associate Director, Feasibility - Internal Strategy, Operations & Process
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About This Role
The Associate Director, Feasibility (Internal Strategy, Operations, and Process) will play a critical leadership role in driving internal strategy, operational excellence, and process optimization for the Feasibility Center of Excellence (FCoE) function. This role will drive key internal initiatives and help evolve the team’s operating model. The ideal candidate has strong project leadership capabilities, deep strategic feasibility experience, and a passion for continuous improvement and change management.
This individual will also serve as a feasibility strategy lead, acting as a key member of study management teams and providing data analysis, enrollment projections, and subject-matter expertise to shape feasibility strategy for Biogen clinical research programs.
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. The successful candidate will be a key contributor and leader for task forces, initiatives, and/or working groups.
What You’ll Do
- Lead internal initiatives that enhance Feasibility operations, strategy, communications, and team process efficiency.
- Identify opportunities to effectively scale and improve processes in support of continuous innovation.
- Drive process improvement, SOP/work instruction development, and change management.
- Enhance team use of project management tools and digital platforms.
- Provide leadership, mentorship, and (as applicable) line management to team members.
- Serve as feasibility strategy lead for Biogen clinical research programs
- Generate data-driven insights to support decision-making and operational trial performance. Support all relevant governance and planning meetings (e.g., Baseline Forum, business development due diligence, etc.) Engage with program and study teams to build and analyze what-if scenarios and enrollment modelling for 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.
- Build, manage, and optimize SharePoint sites and knowledge management structures.
- Develop high-quality PowerPoint visualizations and support rebranding of Feasibility deliverables.
- 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, lead identification, and assessment of innovative approaches. Identify, build, and manage effective relationships with academic, corporate and vendor consortiums, acting as 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 are experienced in leading business critical process improvement initiatives. You have demonstrated wins in leading cross-functional initiatives and complex projects from concept to implementation. You love analytics and are passionate about using data to drive key business decisions. 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 combination of internal project management/process optimization, study feasibility, and/or study design optimization and/or clinical operations project management at a global level.
- Experience in developing and rolling out portfolio wide initiatives to improve exisitng processes and tools
- 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 Lean, Six Sigma, Agile, etc.
- End-to-end initiativel-implementation experience from the business side (requirements gathering, UAT, change management, and adoption metrics)
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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