The Vice President of Process and Product Development for Gene Therapy is a key leadership role in the Pharmaceutical Operations & Technology (PO&T) organization, responsible for creating the product and technology development strategy of gene therapy drugs in Biogen. The successful candidate will be able to take the function forward in a transformative manner in the gene therapy space, with a clear vision for the future.

This is a critical leadership position, focused on process and technology development in PO&T, that closely collaborates with external company Partners, and R&D Gene Therapy Accelerator portfolio, from early development & translational R&D through preparation for hand-over to Global Manufacturing Technical Operations (GMTO) for commercialization and the execution of these strategies to regulatory filings and approval.

Reporting into the SVP of Product & Technology Development, the successful executive in this role oversees a multi-disciplinary international team responsible for the development of gene therapy processes and analytics, support of Quality and CMO/CRO strategy, regulatory filings, and technology transfer. The role collaborates within PO&T, and with R&D and Commercial functions though PO&T Asset Teams & the PO&T Governance Committee, to ensure cross-company alignment on product development and resolution of resource conflicts across the portfolio. The incumbent will contribute expert gene therapy and biologics drug development support and decision making to the PO&T Governance Committee.

This role can be in Cambridge, MA, RTP NC or Maidenhead UK, with direct line reports as well as the facilitations of dotted line responsibilities of staff, and considerable partnership/alignment with Asset Development Program Management (ADPM) group.

MAIN RESPONSIBILITIES

•      Provides influential leadership to the gene therapy cross-functional team responsible for supporting Biogen gene therapy and Partner’s programs.

•      Works cross-functionally to drive CMC strategy for gene therapy products.  Identifies and resolves barriers associated with meeting CMC portfolio deliverables to ensure timelines are met. Develops CMC metrics/analytics to support decisions and development timelines.

•      Contributes expertise to PO&T Governance Committee across the portfolio, particularly in gene therapy and biologics. Establishes internal gene therapy consultation and expert teams to support PO&T gene therapy strategy and 5 year plans.

•      Leverages best CMC practices in the industry through professional forums and other external outreach; applies novel and forward-thinking ideas to influences Agencies.  

•      Instills operational excellence and accountability in team members through effective program management, performance metrics, and other management tools including team charters, project plans, and meeting management.

•      Inspires others, develops and engages staff to leverage abilities, and build a sense of belonging for the team.  Manages synergy with line functions with regards to business/plan objectives, resources, and budget allocation in partnership with G&A. 

•       Builds strong working relationships with Senior Leadership in PO&T and key stakeholders in R&D and Commercial. Evaluates opportunities for moving the organization forward, and bringing innovative approaches to the work.

•       Provides an influential voice for Biogen in key industry associations.     

•       20+ years of relevant experience in the pharmaceutical industry, including gene therapy product development and/or commercialization experience. 

•       Strategic, able to see the big picture and consultative to client groups.

•       Innovative and deep technical expertise, with broad technical knowledge in gene therapy and biologics, and strategic product planning and insights,

•       Must have demonstrated experience in leading/engaging others in a direct and highly matrixed and fast growing and global health care organization.

•       Outstanding credibility and influence with senior executive leadership, executive peers, and other internal and external stakeholder groups, and communicate in a clear, concise and effective manner.

•       Must demonstrate exceptional leadership abilities including organizational awareness, business acumen, political astuteness, influencing/negotiations, decision making ability, conflict resolution, and positive motivation and courage. 

•       Demonstrated strategic leadership through proactive engagement with the senior stakeholders, and through proactive communication at key meetings with PO&T leaders as well as external agencies. Demonstrated success in alliance and partner management.

•       Proven success in managing complex development portfolios and project plans.

•       Proven track record of leading and managing a multidisciplinary team, and effectively guiding the team, coaching and developing internal talent.

•       Strong interpersonal skills and ability to work with cross-functional teams.

•       An individual of unquestioned personal and business integrity who will be viewed as trustworthy both within the company and externally.

•       Strong track record of outstanding decision-making abilities—able to make decisions logically, methodically, and quickly (as appropriate).

Education

•      MS, PhD preferred in pharmaceutical-related field.