CMC Asset Lead

About This Role

The Pharmaceutical Operations and Technology (PO&T) Division is looking to hire a CMC Asset Lead. This Asset Lead is a member of the Asset Development & Portfolio Management (ADPM) team which provides cross-functional leadership across PO&T’s line functions. The PO&T Asset Lead is accountable for end-to-end asset leadership including asset strategy, development, supply and life cycle management planning for all CMC aspects of clinical biopharmaceutical programs.

This PO&T Asset Lead role is specifically responsible for leading CMC of one or more clinical programs. Late-stage programs require management of corporate partnership contributions to product commercialization, including management of joint manufacturing committees, and planning life cycle management activities.

This is a hybrid that can be based either at our offices in Cambridge, MA or RTP, NC.

• Serve as the PO&T “asset owner” of clinical biologics programs, with accountability for delivering a 5-year PO&T Asset Strategy, maintenance of an 18-month rolling Tactical Plan, monitoring key program risks and development of risk mitigation plans
• Lead the cross-functional PO&T Asset Team (i.e., including representatives from each PO&T Line Function) in the development of and delivery on the PO&T Asset Strategy & Tactical Plan
• Serve as PO&T’s representative on the R&D Program teams and Commercial teams; acts as in influencer and liaison between R&D, Commercial and PO&T leadership.
• Key contact to partner companies co-developing late-stage biologics. CMC leadership of asset requires influencing of partner company through management of joint-CMC meetings and joint collaboration governance
• Proactively manage conflicts with the Asset Strategy (e.g., driven by other Assets and/or Line Function priorities) in consultation with the PO&T Governance Committee, Research/Commercial governance, or corporate partners.
• Monitor asset-related impacts on the P&L (e.g., COGS, E&O, OPEX) and collaborate with the PO&T Line Functions to develop tactics to improve them. Develop business cases for key Asset initiatives and secure management endorsement at the PO&T Governance Committee

You are a seasoned leader with in-depth experience in drug development, supply chain or manufacturing. You will be part of ADPM and lead teams representing PO&T disciplines and maintaining critical partnerships with relevant program R&D and/or product commercial leaders. You will be instrumental in leading and facilitating key aspects of the PO&T vision through engagement/oversight of partner-company collaborations, driving best practices for resource management/forecasting, decision gates and associated knowledge management initiatives.

• Bachelor’s degree and a minimum of 12 years of relevant experience with a focus on matrix management. Advanced degree (MS, PhD, MBA) preferred in a relevant biopharmaceutical discipline.
• Track record of effective matrix leadership experience in the setting of program teams across the full product life cycle, e.g., (CMC) PO&T line functions sub-teams or other cross-functional teams operating in a matrix environment ideally across an organization
• Experience with CMC, supply chain, or LCM development extending from IND to NDA/BLA, including a solid understanding of global registration processes. Technical expertise in one or more relevant biopharmaceutical development disciplines
• Experience in healthcare/biotech/pharmaceutical industry with a demonstrated understanding of cross-functional interdependencies (i.e., R&D, commercial, technical development, regulatory)
• Excellent strategic, political, organizational, and relationship development skills
• Demonstrated ability to lead, motivate, influence without authority a strategic direction; ability to effectively leverage and develop diverse perspectives and ideas from matrix teams and others.
• Excellent communication, negotiation, problem solving and decision-making abilities
• Demonstrated ability to identify critical program risks and develop mitigation plans – strategic or tactical to mitigate risk, costs, and reputation of Biogen.

The base…