Johnson & Johnson is seeking a Director Clinical Research Oncology to join their Innovative Medicine team. This role involves leading the implementation of clinical research studies within a global compound development program, focusing on new oncology applications. The Director will provide scientific contributions, mentor clinical study teams, and ensure the flawless execution and reporting of clinical studies, ultimately contributing to the development of life-saving medicines.

Practice Info

• Member of a matrix team dedicated to the implementation of clinical research studies

• Supports the Clinical Leader and provides active scientific contributions to a cross-functional clinical team developing a compound currently being studied for new oncology applications

• Works closely with the clinical project scientists and Clinical Leader in Late Development, in collaboration with other functional disciplines, including GCO, Data Management, Statistics, Regulatory, QMMC, and GMS

• Reports directly to a Clinical Leader for the product to which he/she is assigned

Responsibilities

• Lead project scientists, ensuring appropriate training, mentoring, and supervision across assigned 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)

• Provide support for clinical study/studies within a development program, including medical monitoring, addressing site issues, and reviewing serious adverse events

• Ensure development of high quality study protocols and collaborate on key study design elements

• Participate in strategic study start-up planning, including early site assessment and feasibility

• Co-lead and oversee clinical development/authorship of informed consent forms, eCRFs, study manuals, clinical study reports, and regulatory submission documents

• Work 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

• Review/co-author medical publications emerging from clinical trial results and interact with medical consultants in conducting IDMC and Investigator meetings as well as Advisory Boards

Shift & Schedule

• Travel required may be up to 20-30% annually (international, as well as domestic)

Requirements

• Advanced Degree in Medicine (i.e. M.D or equivalent) is required

• 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 is required

• 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

• Ability to use influencing skills is required

• No visa sponsorship available