Medical Director, Study Responsibly Physician - Oncology Late Development

Job Description At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. ESSENTIAL FUNCTIONS Lead the project scientists, ensuring appropriate training, mentoring, and supervision across the assigned study/studies within the clinical development program. Work closely with functional partners (Data Management, Biostatistics, Regulatory, GCO, QMMC, GMS) to ensure an integrated and strategic approach to flawless execution and systematic oversight of study protocol(s) in late development. Provide support for clinical study/studies within a development program, including collaboration with clinical project scientists in GCO and GMS to ensure comprehensive medical monitoring, thorough and timely responses to address site issues and eligibility questions, and detailed, real‑time review of serious adverse events and deaths. Ensure development of high‑quality study protocols with consistent processes and standards across studies. Collaborate with the Clinical Leader, Clinical Project Scientists, and Procurement on key study design elements, including assessment of complexity and cost of protocol‑required evaluations. Participate in strategic study start‑up planning in collaboration with GCO and C&G, including early site assessment, feasibility, and use of simplified contract and budget templates to accelerate site activations. Co‑lead and oversee clinical development/authorship of informed consent forms, eCRFs, study manuals, clinical study reports, and regulatory submission documents. Work closely with Medical Writing to support protocol or protocol amendment completion. Address protocol questions from Health Authorities and Ethics Committees in collaboration with Regulatory and GCO. Track study recruitment and implement action plans to address early impediments to study enrollment with GCO. Work with Quality Management & Quality Assurance to review audit findings and implement effective corrective action plans. Support medical review and data query resolution with clinical scientists and data management. Interact with clinical investigators and Key Opinion Leaders as appropriate. Provide oversight of CRO/study vendors’ performance related to study start‑up and conduct. Assist with analysis of study results and completion of study reports with Data Management and Statistics. Support the development and compilation of NDA/MAAs and respond to Health Authority questions and HA presentations post‑filing. May review/co‑author medical publications emerging from clinical trial results. May interact with medical consultants in concert with senior clinical staff, conducting IDMC and Investigator meetings as well as Advisory Boards. QUALIFICATIONS Advanced Degree in Medicine (M.D. or equivalent). Board‑certified or board‑eligible Uro‑Oncologist/Oncologist (strongly preferred). Post‑doctoral fellowship training required. Minimum of 3 years of experience in a relevant urology/oncology clinical research position. Significant knowledge of basic and clinical cancer research and its application to cancer drug development. Strong oral, written, and presentation communication skills. Successful work experience in a matrix team environment with cross‑functional teams. Ability to use influencing skills. Travel required may be up to 20–30% annually (international and domestic). Required Skills Business Savvy Clinical Research and Regulations Clinical Trials Collaborating Consulting Data Management and Informatics Design Mindset Drug Discovery Development Industry Analysis Innovation Market Research Regulatory Affairs Management Research Ethics Scientific Evaluation Scientific Research Stakeholder Management Strategic Analysis Preferred Skills Business Savvy Clinical Research and Regulations Clinical Trials Collaborating Consulting Data Management and Informatics Design Mindset Drug Discovery Development Industry Analysis Innovation Market Research Regulatory Affairs Management Research Ethics Scientific Evaluation Scientific Research Stakeholder Management Strategic Analysis The anticipated base pay range for this position is $199,000.00 - $343,850.00. #J-18808-Ljbffr