Senior Director, Solution Development Team Leader, LCI

At J&J, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We collaborate with the world for the health of everyone in it. The Lung Cancer Initiative (LCI), which is a cross-sector initiative, is charged by the Executive Committee of J&J with meaningfully altering the course of lung cancer and improving survival by preventing, intercepting, and curing lung cancer. The Johnson & Johnson Lung Cancer Initiative (LCI) is recruiting for a Solution Development Team Leader (SDTL) within the Pharmaceutical Sciences team of the Johnson & Johnson Lung Cancer Initiative. The SDTL is responsible for the execution of high priority and high visibility LCI Development Programs. The Programs may be focused on developing products that could include a novel molecular entity, drug and device combinations, diagnostic tests, or other combinations of products necessary to deliver against the agreed Target Product Profile. The SDTL is accountable for delivery of programs from IND-enabling preclinical development studies through PoC and possibly initial registration. The SDTL must ensure appropriate governance is followed within the LCI (and relevant sectors within Johnson & Johnson) for projects and that activities are conducted to the appropriate GLP/GMP/GCP to guarantee the integrity of data. It is expected that new processes and procedures will be needed to operate most efficiently in this new paradigm, and this leader will work with the Pharm Science Leader and the LCI Leadership team to both develop and execute in this new paradigm. As part of the work with the external environment, this leader will work with key External Innovation personnel to identify novel solutions to ensure the execution of this strategy. ESSENTIAL FUNCTIONS: (CORE Responsibilities) 1. Develop a clear strategy with the LCI Pharm Science and Clinical Development Leaders and provide a clear vision and strategic direction to the Solution Development Project teams 2. Participate in the design of the development strategy and managing the governance process for clinical programs with the LCI Clinical Development Leader to meet stated objectives of the Program’s short- and long-term strategy 3. Lead cross-functional teams of experts to ensure the efficient execution of the Program, which includes setting up and running clinical studies for small and/or large molecules through the early clinical development phase (from FIH to end of Proof of concept) 4. Develop and maintain collaborative relationships with individuals and groups within the organization required for successful execution of Program. This includes primarily the Oncology, especially immuno-oncology, therapeutic area at Janssen and key functional groups from the Janssen R&D (eg, Non-Clinical Safety, Clinical Pharmacology, CMC, and DMPK) 5. Leverage existing capabilities and resources that exist within Johnson & Johnson where possible, but also look to the external landscape to access functional expertise when necessary 6. In partnership with regulatory leaders, drive the Program team’s preparation of regulatory documents including IDEs, INDs, briefing books, BLAs/PMAs and other regulatory submissions with Regulatory Leaders from GEI and Janssen 7. Provide oversight, set priorities, and coach individuals leading projects within the Program 8. Manage external alliances leading co-development or licensing partnerships 9. Participate in strategic direction setting for LCI by presentations at LCI Core Team meetings, pillar meetings, scientific forum and in evaluating new business opportunities. 10. Represent LCI at presentations to senior management including Development Committees, First in Human Committee as well as GOC, Executive Committee, corporate partners, Global regulatory agencies and the public at scientific meetings. This is not an exhaustive, comprehensive listing of job functions. May perform other duties as assigned. Location & Travel: location will be flexible based on the candidate. Ideally co-located with the LCI team in either: Spring House, PA; Boston, MA; Raritan, NJ, New Brunswick, NJ, or London, UK. The expectation for travel is approximately 20% of time (depending on location) including team meetings in locations listed above as well as travel to global regulatory agencies and National/International scientific congresses. Qualifications Required Minimum Education: Ph.D. in biological (Pharmacology, Immunology, or Oncology) or chemical sciences or MD required, but candidates with a relevant MS degree will be considered Required Years of Related Experience Minimum 10+ years relevant post-doctoral experience, 15+ years post-graduate, industry drug development experience for candidates with a MS Other qualifications: • Experience and a successful track record in a range of leadership roles in drug development in the oncology area required • Experience in immuno-oncology or lung cancer drug development preferred • Experience in leading cross-functional earl-y and late-stage clinical pharmaceutical development teams and driving compound early development strategy required • Ability to successfully work in a matrixed environment and experience developing collaborative relationships with KOLs and alliance stakeholders required • Comprehensive understanding of regulatory guidance documents required • Demonstrated ability to present scientific content to diverse audiences required • Successful track record of strategic alliance management highly desirable • Learning agility and ability to works across multiple sectors (pharm, medical device, and or consumer) highly desirable • Experience working in a virtual environment and/or with global teams highly desirable • Previous experience in people leadership preferred Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Primary Location United States-New Jersey-New Brunswick-One Johnson & Johnson Plaza Other Locations North America-United States-Massachusetts-Boston, North America-United States-New Jersey-Raritan, Europe/Middle East/Africa-United Kingdom-England-London, North America-United States-Pennsylvania-Spring House Organization Johnson & Johnson Enterprise Innovation Inc. (6268) Job Function R&D Requisition ID 2206039723W