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Director Clinical Research Physician Oncology Experimental Medicine Early Development

Raritan, NJ

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Janssen Research & Development, LLC is recruiting for a Director, Clinical Research Physician - Oncology - Experimental Medicine & Early Development to be in Spring House, PA or Raritan, NJ. Less than 10% travel is required for this position. At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit ****for more information. We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it. Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer. The Oncology Therapeutic Area physician-scientist will 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 and report to the Early Development Clinical Leader. 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:u2022Design 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.u2022tYou 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 within the Tumor Strongholds in disease areas such as prostate or lung cancer.This role requires:u2022tA high-performing physician-scientist familiar with clinical and translational research involving biomarkers and correlative laboratory clinical trial endpoints.u2022tYou 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.u2022tIn this capacity the you will work closely with research group leaders, drug discovery teams, and project clinical teams.u2022tThe ability to communicate effectively with basic laboratory scientists and clinical teams is important.u2022tThe Director is also expected to establish good working relationships and collaborations with external study investigators, key opinion leaders in drug development, and external alliance partners.Qualificationsu2022tAn M.D./Ph.D. with significant scientific research experience.u2022tFormal training in Oncology or Hematology with Board certification or eligibility is required.u2022tA minimum of 5 yearsu2019 experience in clinical research within the pharmaceutical industry or academia is preferred. u2022tSignificant knowledge of translational and clinical cancer research and its application to cancer drug development is of paramount importance.u2022tA working knowledge of the key areas of early drug development, including chemistry, biology, toxicology and early clinical development is required.u2022tKnowledge of clinical pharmacology and its relationship to decision making in early drug development is of value.u2022tAlternatively, you could have experience in clinical development, specifically experience in conducting phase II or III clinical trial and deep understanding of relevant regulatory health authority expectations and regulations.u2022tAbility to strategize and lead a goal oriented clinical development team will be very valuable. We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. IND8

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