BS or equivalent in Sciences/Engineering with an advanced degree (MS, PhD, MBA) preferred in a relevant pharmaceutical discipline
Minimum of 12 years experience with a focus on matrix management
Experience with CMC, LCM development extending from IND to NDA/BLA, including a solid understanding of global registration processes
Technical expertise in small molecule and/or ASOs
Track record of effective matrix leadership in program teams across CMC technical and manufacturing line function sub-teams or other cross-functional teams operating in a matrix environment ideally across an organization and globally
Experience in healthcare/biotech/pharmaceutical industry with a demonstrated understanding of cross-functional interdependencies (i.e., R&D, commercial, technical development, regulatory), ASO/Small molecules a plus
Understanding of business contracts and management; Alliance management experience, a plus
Excellent strategic, political, organizational, and relationship development skills
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
Responsibilities
Serve as the PO&T “asset owner” 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 PDC teams; acts as an influencer and liaison between R&D, Commercial and PO&T in support on asset(s)
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. Ensure alignment and accountability of PO&T Line Functions for providing support for their needs balanced with the needs of the Asset Strategy
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