Head of Product Development and RegCMC, Biologics and Advanced Therapy Medicinal Products - Biogen

This role is located in Cambridge, MA or RTP, NC.

The Head of Product Development and RegCMC, Biologics and Advanced Therapy Medicinal Products leadership role in PO&T is responsible for the process, analytical, and technology development of all biologic and advanced therapy medicinal product (ATMP) modalities including existing protein-based drugs, monoclonal antibodies, and gene therapy assets. The role has end-to-end CMC product responsibilities from pre-clinical to commercial life cycle process development activities, process platform strategies, and regulatory CMC management/filings across the biologics/ATMP modality portfolio. This role is ultimately accountable for delivering GMP-ready processes to manufacturing, phase-appropriate process optimization (i.e., COGS optimization), and regulatory CMC filing/approvability across all global healthcare regions. In addition to process and analytical development, the position oversees multi-disciplinary international teams supporting Quality oversight, CMO/CRO execution and strategy, regulatory filings, and manufacturing technology transfer. The leader guides, coaches, and develops team members to lead, collaborate, and engage in a matrix set of responsibilities with Biogen; this includes 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.

This role sits on the PO&T leadership team, is the primary decision maker as a member of the PO&T Governance Committee (GC) for this modality, and has extensive interface and influence with critical stakeholders including Discovery & Research, Translational Sciences, and Clinical Development, external partners/collaborators representing PO&T on partner joint steering committees and various industry influencing forums.

Principle Accountabilities Include: 

1.  Sets the strategic direction and priorities to ensure development, delivery, life cycle, and regulatory management of programs/products in modality area of responsibility.  Provides leadership, oversight, and direction to the cross-functional team responsible for the work.

2.  Works cross-functionally to drive CMC strategy for products in modality area of responsibility.  Identifies and resolves barriers associated with meeting CMC portfolio deliverables to ensure timelines are met. Develop CMC metrics/analytics to support decisions and development timelines. Represents PO&T in external due diligence and partnership evaluations

3.  Contributes expertise to PO&T GC across the portfolio, particularly in assigned modality area. Establishes expert teams to support PO&T program or product strategy. 

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

5.  Inspires others, develops and engages staff to leverage abilities, and builds 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. 

Who You Are

You are able to balance deep technical expertise with strategic product planning and insights.  You demonstrate exceptional leadership abilities including organizational awareness, business acumen, political astuteness, influencing/negotiations, decision making ability, conflict resolution, and demonstrated ability to influence and inspire teams.  You have a proven track record of success in managing complex development portfolios and project plans and developing internal talent as well as demonstrated success in alliance and partner management.

Education: 

• MS, PhD preferred in pharmaceutical related field.

Experience and Skills: 

• Minimum of 15+ years of relevant experience in the pharmaceutical industry, including product development and/or commercialization experience. 

• Must have demonstrated experience in leading/engaging others in a direct and highly matrixed and fast growing and global health care organization, and broad technical knowledge across multiple modalities.

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.