Medical Director/ Sr. Medical Director, Clinical Development

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. Learn more at https://www.jnj.com/.

Janssen Research & Development, L.L.C, a member of the Johnson & Johnson Family of Companies, is recruiting for a Director/Senior Director, Clinical Rseearch Physician for Late Development Oncology. The preferred location for this position is Raritan, NJ but consideration could be given to other locations. Up to 25% travel may be required.

The Director / Sr. Director, Clinical Development-Oncology will contribute to the development and oversee the execution of oncology clinical research studies, ensuring consistency and quality, across the assigned development program. The successful person in this role will provide mentoring and support to the clinical project scientists on the team and will work with PMO, Finance, and the Clinical Leader to assure appropriate resourcing of clinical studies.

He/She will work closely with the clinical project scientist team and Clinical Leader in Late Development, in collaboration with other functional disciplines, including GCO, Data Management, Statistics, Regulatory, QMMC, and GMS to ensure flawless and integrated execution of study start-up planning, oversight, and reporting of clinical studies in Oncology. Together with the Clinical Leader, the Study Responsible Physician will represent the clinical team in governance and committee meetings relating to the overall strategy and operational implementation of the clinical studies in the development plan.

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 in close collaboration with key functional stakeholders.
• Provide support for clinical study/studies within a development program including:

o Working closely with the colleague study responsible physicians and 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.

o Working in partnership with colleague study responsible physicians and clinical project scientists to ensure development of high quality study protocols including use of consistent processes/standards across studies.

o 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.

o Participate in strategic study start-up planning in collaboration with GCO, C&G, and RTAEs including early site assessment, feasibility, and use of simplified contract and budget templates to accelerate rate of site activations.

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

o Work closely with Medical Writing to support protocol or protocol amendment completion.

o Work closely with Quality Management & Quality Assurance to review audit findings and implement effective corrective action plans.

o Work closely with clinical scientists and data management to support medical review and data query resolution.

o Interact with clinical investigators and Key Opinion Leaders as appropriate.

o Work with the Clinical Leader, with Data Management and with Statistics on analysis of study results and completion of study reports.

• 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.
• May review/co-author medical publications emerging from clinical trial results.
• May act as a liaison between company and clinical investigators, vendor managers, and CROs.
• May be asked to assess and plan for external clinical research opportunities in collaboration with Clinical Leader and BD.
• May interact with medical consultants in concert with senior clinical staff, in conducting IDMC and Investigator meetings as well as Advisory Boards.