Job Function Discovery & Pre-Clinical/Clinical Development Job Sub Function Clinical Development & Research – Non-MD Location Raritan, New Jersey; Spring House, Pennsylvania. Job Description Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science‑based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Our Oncology team focuses on the elimination of cancer by discovering new pathways and modalities to find treatments and cures. We lead where medicine is going and need innovators with an unwavering commitment to results. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Johnson & Johnson Innovative Medicine is currently searching for a Director, Clinical Science / Sr. Clinical Science Group Leader. This is a hybrid‑based role (≥ three days onsite) at any of the listed locations. Remote options may be considered on a case‑by‑case basis and if approved by the company. Responsibilities Drive clinical development strategy, contribute to the development of other study‑related materials (e.g. ADP, SAP, CSR outputs, case report forms, operational plans) and provide clinical representation for study‑related review committees (e.g. first in human committee, protocol review committee). Lead the execution of clinical trial protocols within the clinical development program, ensuring compliance with scientific, organizational, and regulatory standards. Oversee end‑to‑end delivery of clinical trial protocols/programs, including study design, initiation, medical safety data monitoring, data dissemination, and closeout activities. Manage and coordinate activities with internal functional partners and external partners to ensure timely scientific and clinical execution of clinical studies. Maintain the quality and integrity of clinical data critical to the evaluation of study endpoints. Interact and collaborate with investigators and study teams during the conduct of the trial(s). Lead training on study protocol, disease evaluation criteria, and other essential components to enhance the understanding of clinical development processes. Review, interpret, and report clinical trial data, ensuring accuracy and integrity for health authority submissions. Draft documents for reporting clinical trial data (e.g., clinical study reports, patient narratives, investigator brochures, and periodic safety updates). Collaborate with Study Responsible Scientist and Study Responsible Physician to assess and evaluate clinical trial medical/safety data (i.e. adverse events, labs, medications, etc.). Establish and define medical data review plan in partnership with Study Responsible Physician. Lead and perform medical data monitoring/reporting and evaluate ongoing clinical trial data. In partnership with Study Responsible Physician, act as a liaison between the company and clinical investigators, fostering collaborations with key opinion leaders and external advisors. Develop and maintain credible relationships with internal and external stakeholders, including senior management, cross‑functional trial teams, and external partners/vendors (e.g. CRO, ARO). Provide mentorship and training to junior team members, fostering a collaborative work environment. Guide and support colleagues in clinical development processes and standards. Identify opportunities for process improvements and drive the implementation of best practices in clinical trial execution. Drive innovative research methods and operational strategies to enhance clinical development efficiency. Collaborate with cross‑functional partners to align clinical strategies with overall product development goals. Participate in governance meetings, as appropriate, and cross‑functional initiatives to promote business strategies and process improvements. Prepare and present findings and results of clinical research at internal and external meetings, including regulatory body interactions and academic partners. May act as an author for scientific publications, as applicable, to influence clinical development practices and advancements. Research and review medical literature and new technologies to support operational planning and scientific strategy implementation. Integrate scientific and technological innovations into clinical trial designs, including biomarkers and digital health initiatives. Education & Experience A minimum of a bachelor’s degree in a scientific or related discipline is required. An advanced degree (e.g., MS, PharmD, PhD) is preferred. Requires 10 years of relevant experience in clinical research and development within the pharmaceutical industry, biotech, CRO, or equivalent. Knowledge and experience in solid tumor cancers specifically prostate cancer is preferred. Strong understanding of clinical development processes, including trial design, protocol development, data analysis, regulatory guidelines, Good Clinical Practice (ICH/GCP), and study execution. Demonstrated experience in managing all aspects of clinical trials, from conception to closure, including data management and quality assurance practices. Proven ability to interpret scientific literature and apply findings strategically within clinical projects. Proficiency in Microsoft Office Suite, especially Excel, Word, and PowerPoint, and familiarity with generative artificial intelligence and clinical trial management software is advantageous. Excellent written and verbal communication skills in English; ability to effectively present information and negotiate with stakeholders. Excellent interpersonal skills with a collaborative approach to working within cross‑functional and global matrix teams. Exceptional organizational skills, ability to manage multiple tasks, prioritize effectively, and respond to changing business needs in a dynamic environment. Proven analytical and problem‑solving capabilities, with a detail‑oriented mindset. Ability to proactively identify program‑level discussions that require escalation. Ability to handle complex projects to overcome delays and obstacles to meet deadlines. Experience leading scientific teams, providing mentorship, and managing direct or indirect reports. Strong project and time management skills; ability to develop timelines and ensure deliverables are met within project scopes. Willingness to travel domestically and internationally, approximately 10%, as required by project needs. A commitment to maintaining high ethical standards and fostering a culture of inclusivity in the workplace. Required Skills Clinical Data Management Clinical Evaluations Consulting Developing Others Drug Discovery Development Entrepreneurship Good Clinical Practice (GCP) Inclusive Leadership Leadership Medicines and Device Development and Regulation Operational Excellence Regulatory Affairs Management Relationship Building Safety‑Oriented Scientific Research Strategic Change Study Management Team Management Preferred Skills Clinical Data Management Clinical Evaluations Consulting Developing Others Drug Discovery Development Entrepreneurship Good Clinical Practice (GCP) Inclusive Leadership Leadership Medicines and Device Development and Regulation Operational Excellence Regulatory Affairs Management Relationship Building Safety‑Oriented Scientific Research Strategic Change Study Management Team Management Equitable Employment Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Compensation & Benefits Base pay range: $164,000.00 – $282,900.00. Eligible for the company’s long‑term incentive program. Vacation – 120 hours per calendar year. Sick time – 40 hours per calendar year; 48 hours for Colorado; 56 hours for Washington. Holiday pay, including floating holidays – 13 days per calendar year. Work, Personal and Family Time – up to 40 hours per calendar year. Parental Leave – 480 hours within one year of birth/adoption/foster care. Bereavement Leave – 240 hours for an immediate family member; 40 hours for an extended family member per calendar year. Caregiver Leave – 80 hours in a 52‑week rolling period. Volunteer Leave – 32 hours per calendar year. Military Spouse Time‑Off – 80 hours per calendar year. For additional general information on company benefits, please visit #J-18808-Ljbffr