Johnson & Johnson Careers

Senior Director, Compound Development Team Leader (CDTL)-Oncology

Titusville, New Jersey
Clinical Research MD


Job Description

Requisition ID: 1404190409

The Portfolio Leader/Compound Development Team Leader (CDTL)-Oncology Established Products is responsible for development and execution of the portfolio strategy and compound strategies for multiple marketed products. This includes support for global registration, post-marketing requirements, health authority interactions and in-line support of products in the market. Operational implementation is delivered through effective leadership of cross-functional Compound Development Teams (CDT). Excellent matrix leadership skills are therefore of the essence. Team leadership via matrix interactions includes individuals from line functions such as Clinical, Project Management, Global Regulatory Affairs, Pharmaceutical Development & Manufacturing Sciences (PDMS), Clinical Pharmacology, Global Strategic Marketing, Global Medical Safety, Janssen Supply Chain (JSC), Drug Safety Sciences and other scientific and business-related disciplines as relevant. The CDTL will directly supervise the Clinical Leader(s) assigned to the Oncology Established Products portfolio and is accountable for the professional development of members of the cross functional team.

The Portfolio Leader/Compound Development Team Leader (CDTL) provides strategic perspective, expertise and senior level guidance to actively contribute to Compound Strategy decisions of multiple CDTs. S/he will lead the development and maintenance of the integrated project plans and compound
strategies and manage successful cross-functional execution of these plans. S/he will properly manage cross-functional resources through efficient teams and personal involvement with strategic partners to achieve the goals of the portfolio plans. S/he will drive Portfolio Optimization activities, including new formulations, divestitures/de-listings, identify issues and lead contingency planning. This senior role requires excellent ability to prepare data and succinctly present and lead discussions with health authorities, thought leaders, and scientific communities. Communication to Senior Leadership is an integral part of the responsibilities.

Additional Responsibilities Include:
• Actively contribute to Compound Strategy decisions of multiple CDTs by providing relevant strategic perspective, expertise and senior level guidance
• Lead the development and maintenance of the multiple integrated project plans and compound strategies as required for specific products within the Portfolio
• Manage successful cross-functional execution of the integrated project plans and specific compound strategies through proper management of cross-functional resources in various settings such as CDTs where relevant, smaller teams as is most efficient, and personal involvement with various strategic partners
• Aligns the P/CDT to achieve its goals through the networks of people/functions represented on the team
• Participate in Portfolio Optimization activities, including new formulations, divesting/delisting
• Identify issues and lead contingency planning communicating to Senior Leadership
• Lead resolution of conflicts within the P/CDT, DMC (Development Committee) and senior management levels
• Lead P/CDT problem-solving and provide decision-making tools and techniques
• Lead the communication of strategy and plans to the GMO management, DC (when relevant), and to other functional managements (global regulatory, JSC, and commercial partners, and other key stakeholders)
• Identify critical risks and assumptions and transparently communicate them to the P/CDT, functional representatives, DC (as needed), and to senior management.
• Prepare Development Plans for: Pediatric drug development, New indications for existing products, Evaluation of new markets, Post-approval commitments, Clinical programs requested by Health Authorities to address safety-related questions.
• Issue Management: Managing new or existing safety issues, Brand/ SKU recalls, delisting/ divesting, CMC issues, Clinical or commercial supply issues
• Compliance Management: Responding to Health Authority Requests, IND/NDA and other HA periodic updates, IB and CCDS update, Addendum to Clinical Overviews, PBRERs, Article 45 Pediatric Workshare, Article 31


Qualifications
• An MD is required.
• Subspecialty training is preferred.
• At least ten years of pharmaceutical industry experience overall and at least five years of clinical development experience and/or medical affairs experience is preferred.
• Pharmacovigilance experience is preferred. Experience working on a Compound Development Team, a leadership role within a multi-functional R&D organization, ability to integrate all functional disciplines into a strategy and plan are all preferred.
• Expert knowledge of global registration and commercialization is preferred.
• Strong problem-solving skills for developing creative solutions and meeting project objectives are required. Strong planning skills are required.
• Demonstrated influence, negotiation and conflict resolution skills, including the ability to influence without reporting authority, are required.
• Strong oral and written communication skills are essential.
• 10 -20% time of domestic and international travel is anticipated.


Primary Location
United States-New Jersey-Titusville-
Other Locations
North America, Europe/Middle East/Africa, Asia Pacific
Organization
Janssen Research & Development, LLC. (6084)
Job Function
Clinical Research MD
Requisition ID
1404190409