Janssen R&D, L.L.C. is recruiting for a Director, Clinical Research Physician - Oncology - Experimental Medicine & Early Development to be located in Spring House, PA or Raritan, NJ.
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The Oncology Therapeutic Area is recruiting for physician-scientist to serve as a Director, Clinical Research working on novel anti-cancer compounds in early stages of development, from First-in-Human/Phase 1 until Proof of Concept. This position will reside within the Experimental Medicine and Early Development group . This position will be responsible for the development and execution of early stage clinical projects as a member of the cross-functional Compound Development Team and as the co-leader of the Clinical Study Team.
The Director, Clinical Research will be responsible for the following:
• Design and conduct early clinical Phase 1 and Proof-Of-Concept development trials, assess clinical safety and efficacy data, and write clinical study reports, clinical sections of INDs, Investigator Brochures, etc.
• This individual will also work closely with biomarker, discovery and translational research scientists. He or she will interpret reports, prepare oral and written results of product research, and participate in the discussion of strategies formulated across the disease area strongholds in Oncology.
This role requires:
• A high-performing physician-scientist familiar with clinical and translational research involving biomarkers and correlative laboratory clinical trial endpoints.
• This individual will be required to collaborate closely with relevant functions within Janssen Pharmaceuticals including discovery, translational, and biomarker research scientists, toxicologists, clinical pharmacologists, drug safety specialists, as well as personnel from Global Clinical Operations, Global Strategic Marketing, and other support functions.
• In this capacity the successful candidate will works closely with research group leaders, drug discovery teams, and project clinical teams.
• The ability to communicate effectively with basic laboratory scientists and clinical teams is essential.
• The Director is also expected to establish strong working relationships and collaborations with external study investigators, key opinion leaders in drug development, and external alliance partners.
• An MD/Ph.D. or an MD with significant scientific research experience is required.
• Formal training in Oncology or Hematology with Board certification or eligibility is required.
• A minimum of 5 or more years’ experience in clinical research within the pharmaceutical industry or academia is preferred.
• Significant knowledge of translational and clinical cancer research and its application to cancer drug development is of paramount importance is required.
• A working knowledge of the key areas of early drug development, including chemistry, biology, toxicology and early clinical development is required.
• Knowledge of clinical pharmacology and its relationship to decision making in early drug development is of value.
• Alternatively the candidate could have experience in clinical development, specifically experience in conducting phase II or III clinical trial and strong understanding of relevant regulatory health authority expectations and regulations.
• Ability to strategize and lead a goal oriented clinical development team will be very valuable.