2025-04-15

Job Description:

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.

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Job Responsibilities:

• Work closely with GCO to track study recruitment and implement action plans to address early impediments to study enrollment.
• 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 Quality Management & Quality Assurance to review audit findings and implement effective corrective action plans.
• Co-lead and oversee clinical development/authorship of informed consent forms, eCRFs, study manuals, clinical study reports, and regulatory submission documents.
• Work closely with clinical scientists and data management to support medical review and data query resolution.
• 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.
• Work closely with Medical Writing to support protocol or protocol amendment completion.
• 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.
• 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:
• 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.
• Lead the project scientists, ensuring appropriate training, mentoring, and supervision across the assigned study/studies within the clinical development program.
• 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.

Job Requirements:

• Knowledge of Good Clinical Practices and regulatory requirements for the conduct of high-quality oncology clinical trials is required.
• Fluent in written and spoken English with excellent communication skills is required.
• An MD is required; Advanced degree (PhD) is a plus.
• A minimum of 2 years of clinical research experience in clinical development within pharmaceutical industry or equivalent experience in academic or large regional hospital is required.
• Oncology experience is preferred, but not required.
• Working knowledge of the use of Microsoft suite of software products including Excel and Word is required.
• Experience in protocol development, medical review, oversight of study conduct, running trials, key stakeholder engagement, data quality, and safety are strongly preferred.

Job Details:

Company: Johnson & Johnson

Vacancy Type: Full Time

Job Location: Bridgewater, NJ, US

Application Deadline: N/A

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