Biogen

Associate Director, Feasibility – Internal Strategy, Operations & Process

Biogen

full-time

Posted on:

Location Type: Remote

Location: United States

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Salary

💰 $153,000 - $211,000 per year

Job Level

Senior

About the role

  • 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.

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.
  • 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)
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

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
data analysisprocess improvementproject managementclinical trial designchange managementLeanSix SigmaAgileSOP developmentenrollment modeling
Soft skills
leadershipmentorshipcommunicationrelationship managementstrategic thinkingproblem-solvingcollaborationanalytical skillsinnovationorganizational skills