VP Portfolio Development Lead - Milvexian

The Janssen Pharmaceutical company in Johnson & Johnson is recruiting for a VP, Portfolio Development Lead -- Milvexian, located in Raritan, NJ.

Janssen’s Cardiovascular, Metabolism, Retina and Pulmonary Hypertension Therapeutic Area is looking to hire an outstanding leader as Portfolio Development Lead (PDL) to spearhead and execute our anti-thrombotic Milvexian program. Milvexian is a novel, direct-acting, reversible, high-affinity inhibitor of activated human coagulation Factor XI (Factor XIa or FXIa), a serine protease involved in the intrinsic pathway of the coagulation cascade. Milvexian is an orally administered anticoagulant being targeted for prevention of atherothrombotic and thromboembolic events and, if approved, may significantly improve outcomes for patients. Grounded in strong Phase 2 efficacy data, the Milvexian program (LIBREXIA) aims to enhance the benefit risk profile by delivering reduced thrombotic events with less bleeding for more patients in need.

Janssen is co-developing this asset as part of a collaboration agreement with Bristol Myers Squibb Company. The LIBREXIA program is the most comprehensive and unrivaled FXIa clinical development program today and is a highly prioritized project in Janssen. The PDL will lead a cross-functional global program team to execute the phase 3 program, obtain regulatory approval with Milvexian in the core indications, and demonstrate value to achieve target reimbursement. In addition, the PDL will look to build additional patient value as part of the lifecycle of the asset. In this leadership role, the PDL will provide overall strategic and operational oversight of the development and execution of the asset and each indication and provide direct line management to 3-4 indication CDTLs. The PDL will report to the Head of Late Development in the TA.

The PDL will be responsible for leading dedicated Indication CDTs (iCDTs), one for each core indication. These iCDTs will be fully accountable and dedicated to the individual indication. The PDL will help ensure that the asset be developed and launched to approved timelines, to budget, and with the highest data quality.

Key Responsibilities:

• Lead the development and execution, while maximizing the value creation of Milvexian across multiple indications, crafting a global vision and value proposition for the asset/portfolio, including identifying potential new indications to be pursued and sequencing of these indications.
• Leads a Global Portfolio Team with representation from appropriate functional partners, for the creation of a Development Plan that provides a thorough and clear asset strategy, integrating input from all functional areas, identifying key development issues and the strategic approach to each, with associated timelines and budgets, offering clarity on alternative pathways and tradeoffs considered.
• Creates target product profiles in collaboration with commercial, market access and clinical groups, and adjust this profile as new information and insights are gained
• Drives decision-making on asset strategy, ensuring relevant research, analysis, competitive data, and expertise are taken into account.
• Leads discussions at the Global Portfolio Team level to reach decisions, including making final decisions when full consensus cannot be reached.
• Challenges functional representatives to ensure that all issues and questions are being addressed, and that functional area input into the strategy is adequate to meet the needs of the compound
• Manages the complexity of internal/external development activities and proactively identifies issues and risks while leading contingency planning and problem solving at early stages of development.
• Ensures development and implementation of optimal IP, publication and regulatory strategies to protect asset value.
• Collaborates closely with the PML assigned to the Global Portfolio Team on the asset to plan fit-for-purpose resources (FTEs and budget) to deliver the program and ensure adequate project resource utilization and budget management, providing clarity and transparency on changes and potential tradeoffs.
• Mentors and coaches assigned team members to lead sub-teams and other Development Programs as required.
• Plays an active role in the Alliance with BMS, serving as the R&D representative on the Joint Development Committee (JDC).
• Ensures alignment with Leadership and executes on feedback with regard to decisions, timelines, key studies, resource allocations and budgets, valuations and prioritization.
• Presents strategic issues and phase transition proposals at governance boards.
• Plays an active role as a member of the Late Development SLT in the CVMR&PH TA.
• Represents the Milvexian Global Portfolio Team on various cross-functional committees.
• Leads cross-functional/therapeutic area/company initiatives outside of the Global Portfolio Team.
• Participates in portfolio/strategy committees within the DAS/TA.