Associate Director, Feasibility - Internal Strategy, Operations & Process

Biogen

3d•$153,000 - $211,000

About The Position

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.

Requirements

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.

Nice To Haves

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)

Responsibilities

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.

Benefits

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