iCDTL, Compound Development Team Leader

Janssen Pharmaceuticals, a company of Johnson & Johnson, is recruiting for a Senior Director, indication Compound Development Team Leader to be based in Aschwill, Switzerland, or New Jersey, United States.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing, and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.

Pathologic thrombosis is a key area of interest in Janssen’s CVMRPH Therapeutic Area. 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. It is being co-developed as part of a collaboration agreement between Janssen Pharmaceuticals, Inc and Bristol Myers Squibb Company as an orally administered anticoagulant for the potential prevention of atherothrombotic and thromboembolic events. Compelling phase 2 data has led to the planning of a phase 3 program with Milvexian. This global, phase 3 program is called the Librexia Program.

The Librexia program is a highly prioritized project in Janssen. If Milvexian is approved it may significantly improve outcomes for patients. To this end, Janssen is looking to hire an outstanding leader as an indication Compound Development Team Leader (iCDTL). The iCDTL will lead the development of one of the indications for Milvexian in phase 3 in a cross-functional matrix construct, creating a vision and strategy for the asset in this indication, and driving execution of the indication strategy.

The iCDTL will have full oversight and accountability for the delivery of key milestones and value creation across the indication. The iCDTL will help ensure that the asset be developed and launched to approved timelines, to budget, and with the highest data quality.

Responsibilities include but are not limited to:

• Lead the development and execution of the Milvexian strategy in a core indication, creating a global vision and value proposition for the asset, working closely with our partner, BMS
• Obtain regulatory approval with Milvexian in the core indication and demonstrate value to achieve target reimbursement.
• Assembles and leads a cross-functional Indication 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.
  • Is responsible for the target product profile 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 Indication 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
  • Ensures effective planning of resources to deliver phase 3 study
  • Be the Milvexian Champion for the indication
  • 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 in the core indication.
  • Communicates achievements, risks and mitigations to JRD management through the Global Development Head and to the Alliance
  • Collaborates closely with the PML assigned to the Compund Development Teamon 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’ staff/participates in talent development, where and when appropriate
• Ensures alignment with regard to decisions, timelines, key study outputs, resource allocations and budgets, valuations and prioritization.
• Represents the Indication Team as the Global Program level

Qualifications

Capabilities:

• Ideal to have a deep understanding of the unmet need addressed by the asset; Essential to have late-stage drug development expertise. Scientific/disease areas expertise would be ideal but not critical.
• Strong and capable drug development expertise in large phase 3 studies, including NDA/sNDA compilation along with experience with FDA Advisory Committee presentations
• Ability to integrate all cross functional disciplines into a successful strategy
• Experience leading in a matric environment will be essential
• Understanding of requirements for successful commercialization of a new product, including payer landscape across different geographies
• Strong problem-solving skills for developing creative solutions and meeting project objectives
• Strong communication skills
• Influence, negotiation and conflict resolution skills, including the ability to influence without clear reporting authority
• Demonstrated ability of strategic thinking and contingency planning
• Strategic Agility: Understanding big picture for compound and Janssen portfolio, translating scientific and business concepts into short- and long-term deliverables and managing ambiguity, making decisions with incomplete data

Requirements:

• Advanced Degree (Ph.D., M.D., Pharm.D., MBA) with at least 10 years of pharmaceutical industry experience is required
• Experience in a leadership role as part of a research-driven pharmaceutical company is required
• Proven success in cross-functional team leadership, including strategy development and driving tactical delivery of programs
• Experience with clinical development in Thrombosis/large studies is preferred
• Demonstrated influence, negotiation, and conflict resolution skills, including the ability to influence with clear reporting authority, are required
• Outstanding leadership, influence, and communication skills are required

The anticipated base pay range for this position in the US is $182,500-$315,100.

Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, long-term incentive, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .