Medical Director/Senior Medical Director, Oncology Late Development

Johnson & Johnson

Director Clinical Research in Oncology at Johnson & Johnson leading clinical research studies. Collaborating with global teams for cancer drug development and ensuring successful execution of clinical trials.

Posted 6/12/2026full-timeLos Angeles • California, New Jersey, Pennsylvania • 🇺🇸 United StatesSeniorWebsite

About the role

Key responsibilities & impact

Leads the project scientists, ensuring appropriate training, mentoring, and supervision across the assigned study/studies within the clinical development program
Works 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 in close collaboration with key functional stakeholders
Provides support for clinical study/studies within a development program including: Working closely with clinical project scientists in collaboration with 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
Working in partnership with clinical project scientists to ensure development of high quality study protocols including use of consistent processes/standards across studies
Collaborating with the Clinical Leader, Clinical Project Scientists and Procurement on key study design elements including assessment of complexity and cost of protocol-required evaluations
Participating 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 rate of site activations
Co-leading and overseeing clinical development/authorship of informed consent forms, eCRFs, study manuals, clinical study reports, and regulatory submission documents
Working closely with Medical Writing to support protocol or protocol amendment completion
Working closely with Clinical Leader, Regulatory and GCO to address protocol questions from Health Authorities and Ethics Committees in a consistent fashion
Working closely with GCO to track study recruitment and implement action plans to address early impediments to study enrollment
Working closely with Quality Management & Quality Assurance to review audit findings and implement effective corrective action plans
Working closely with clinical scientists and data management to support medical review and data query resolution
Interacting with clinical investigators and Key Opinion Leaders as appropriate
Working with GCO to provide oversight of CRO/study vendors’ performance as it relates to study start-up and conduct
Working with the Clinical Leader, with Data Management and with Statistics on analysis of study results and completion of study reports
Works with the Clinical Leader to support the development and compilation of NDA/MAAs and to support responses to Health Agency 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, in conducting IDMC and Investigator meetings as well as Advisory Boards

Requirements

What you’ll need

A minimum of an Advanced Degree in Medicine (M.D or equivalent)
A trained (Board certified or Board eligible) Uro-Oncologist/Oncologist is strongly preferred
Applicable post-doctoral fellowship training is required
A minimum of 3 or more 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 is important
Strong oral, written communication and presentation skills is required
Successful work experience in a matrix team environment with cross functional teams is required
The ability to use influencing skills is required
Travel required may be up to 20-30% annually (international, as well as domestic)

Benefits

Comp & perks

Health insurance
Inclusive work environment
Professional development opportunities

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

clinical study designmedical monitoringdata query resolutionprotocol developmentregulatory submissionNDA/MAA compilationclinical trial analysisaudit reviewadverse event reportingstudy protocol execution

Soft Skills

communication skillspresentation skillsmentoringcollaborationinfluencing skillsleadershipteamworkproblem-solvingorganizational skillsstrategic planning

Certifications

M.D.Board certified Uro-OncologistBoard eligible Uro-Oncologistpost-doctoral fellowship