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Director, clinical operations – oncology


This is a Full-time position in Cranbury, NJ posted November 29, 2019.

Exciting position has become available on a multi-disciplinary team of world class researchers and drug developers at a growing biopharma searching for a Director, Clinical Operations, who is motivated by science and excited to work on exciting oncology studies.

This company focuses on the development and commercialization of therapies that exploit the metabolic differences between normal cells and cancer cells Job Description Reporting to the VP of Clinical Operations, the Director of Clinical Operations will be a key member of the R&D Team.

He/she will lead the development of the organization to ensure world class clinical trial planning and execution in accordance with associated regulatory guidelines.

This includes being responsible for clinical study conduct including site selection, contract negotiations, study start-up, and real time data delivery, providing leadership and resolution of trial and/or program specific issues to deliver high-quality clinical trial results Contact Details: Full job description and company details are available upon application.

This position is being dealt with by Evan at Meet, call on +1 646-822-2175 or email directly at [email protected] to discuss further and in confidence.

You can find out more about Evan & Meet at Responsibilities: Build and lead clinical operations to support the scope of our clinical development programs including development of central and field-based clinical operations staff Develop the clinical operations strategy and business model to support high-touch, patient-centered clinical trials with a strong focus on adaptive and seamless designs with early generation of data to support registration Develop, propose and implement clinical trial strategy for each pipeline program and indication Provide clinical operations leadership and oversight for all study activities (site identification and selection, enrollment models, clinical supply planning, CRO selection and negotiations, budget planning and trial execution) Skills Required 10+ years of relevant experience in a Clinical Operations function, including 5+ years in a leadership role Previous experience overseeing and completing multiple complex, ONCOLOGY study life cycles.

Phase Ib/II / III experience preferred including IND and NDA/BLA filings Knowledge of the infrastructure and operational characteristics of CROs and centralized services as well as industry standards as applied to ICH guidelines, GCPs and the CFR