Johnson & Johnson Careers
Senior Director, Compound Development Team Leader
New Brunswick, New Jersey
Clinical Research MD
Requisition ID: 4286180627
Janssen Research & Development, L.L.C., a Johnson & Johnson company, is recruiting a Senior Director, Compound Development Team Leader. The preferred location is New Brunswick, NJ however consideration can be given to other North America sites. Up to 30% domestic and international travel is required for this position.
The Senior Director, Compound Development Team Leader (CDTL) will provide leadership to a cross-functional team with responsibility for the compound strategy and execution of a unique program that will be performed under a BARDA government contract. The BARDA contract is for the development of the drug as a radiation and chemical countermeasure as well as an Oncology drug for treatment of patients with Hepatocellular Carcinoma and patients with hematologic malignancies undergoing allogeneic bone marrow transplant.
The CDTL will be responsible for design, implementation, conduct, and interpretation of the HCC oncology and/or HSCT studies (from IND/CTA submission to registration) and supporting the translation of the animal data to humans to obtain approval for the biodefense indications under the Animal Rule. The CDTL is expected to champion the product and guide the communications approach on all CDT matters.
• Actively guide Compound Strategy decision-making by ensuring relevant research, analysis, and expertise is available.
• Lead CDT in partnership with line functions to optimize value of the compound throughout its lifecycle.
• Identify continuous improvements to speed and efficiency without sacrificing quality.
• Build team effectiveness, ensuring cross functional partnerships and ensure that resources are leveraged effectively, with accountability, to achieve development goals.
• Drive collaboration and transparency across all functions on the CDT and challenge team members to be broad and inclusive in their strategy planning.
• Identify potential issues and guide contingency planning with a solution focused mindset.
• Influence decision making and resolve conflicts at the CDT and at the joint steering committee.
• Establish and oversee external partnerships with partner institutions and enable application of novel approaches to the use of real world data and enable pragmatic trials
• Ensure successful implementation of clinical supplies strategy and is accountable for overall budget and project plan deliverables.
• Engage potential external co-development partners
• Represent the compound at the Joint BARDA/Janssen steering committee.
• A Master’s Degree is required. An MD, Ph.D. or M.D./Ph.D. is strongly preferred.
• A minimum of 10 or more years of related experience or previous experience as an Oncology CDTL is required.
• Experience working on clinical development programs within Oncology or Immunology related Therapeutic areas as a part of a research-driven pharmaceutical company is required.
• Expert knowledge of the drug development process and familiarity with pharmaceutical portfolio risk management and the requirements for successful commercialization of a new product is required.
• Experience engaging health authorities through all stages of development including late development (Phase 2/3 and registration) is required.
• Master communicator, able to effectively interact at all levels of the organization is preferred.
• Expert critical interpretation of scientific and commercial data and analytical skill in translating interdisciplinary project information into action plans is required.
• Proven project planning and tracking skills; Demonstrated ability for strategic thinking and contingency planning is preferred.
• Ability to communicate seamlessly between scientific and business partners alike, to negotiate timelines, resources and effective international collaborations is required.
• High degree of organizational awareness and understanding of change management is preferred.
• Business orientation, with prior resource and budget management is required.
• Track record of leading development projects through successful clinical development, registration and launch within the therapeutic area is preferred.
• Highly collaborative with the ability to influence cross-functionally is preferred.
• Excel in partnering with interdisciplinary teams; accessing and optimizing resources within a matrix organization is preferred.
• Excellent communicator with ability to articulate strategy and motivate to action in both scientific and business circles is required.
• A drive for delivering and exceeding results is required.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
United States-New Jersey-New Brunswick
Johnson & Johnson (6067)
Clinical Research MD