Janssen Research and Development, L.L.C., a member of Johnson & Johnson's Family of Companies, is recruiting for a Medical Director/Senior Medical Director-Clinical Research-Bladder. The preferred locations for this position are Spring House, PA or Raritan, NJ; however, we will also consider remote work within the U.S.
The Director / Sr. Director, Clinical Development-Oncology will contribute to the development and oversee the execution of oncology clinical research studies (bladder), 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.
- 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.
- 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.
- 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.
- 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. o Work closely with Clinical Leader, Project Physician, Regulatory and GCO to address protocol questions from Health Authorities and Ethics Committees in a consistent fashion.
- Work closely with GCO to track study recruitment and implement action plans to address early impediments to study enrollment.
- Work closely with Quality Management & Quality Assurance to review audit findings and implement effective corrective action plans.
- Work closely with clinical scientists and data management to support medical review and data query resolution.
- Interact with clinical investigators and Key Opinion Leaders as appropriate.
- Work with GCO to provide oversight of CRO/study vendors’ performance as it relates to study start-up and conduct.
- 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.
- An MD is required; Advanced degree (PhD) is a plus.
- A minimum of 2 years of oncology clinical research experience in clinical development within pharmaceutical industry or equivalent experience in academic or large regional hospital is required.
- Knowledge of Good Clinical Practices and regulatory requirements for the conduct of high quality oncology clinical trials is required.
- Experience in protocol development, medical review, oversight of study conduct, running trials, data quality and safety are strongly preferred.
- Working knowledge of the use of Microsoft suite of software products including Excel and Word is required.
- Fluent in written and spoken English with excellent communication skills is required.
The anticipated base pay range for this position is $187,000 to $322,000.
Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.