Vacancy expired!
Janssen Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies, is recruiting for a Director, Clinical Development, Immunology to be located in Spring House, PA.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 http://www.janssenrnd.com/ 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.This position will serve as a Director Clinical Development for Immunology Therapeutic Area products. The position will support clinical development strategy, and clinical trial protocol design, development and execution. The position will also have a leadership role in the conduct of clinical trials, investigator meetings, regulatory interactions, and study and submission document writing.In collaboration with other members of the Immunology Therapeutic Area organization, the Director responsibilities will include:Clinical development strategies for assets in the immunology/autoimmune disease portfolio, with focus on rheumatology and related disorders
Design, execution, and reporting of Phase 2 and 3 clinical trials
Collaboration with the Janssen Translational Medicine, and Medical Affairs teams to progress Immunology portfolio
Monitoring safety of ongoing clinical trials
Providing clinical expertise and scientific leadership in the areas of responsibility
Leading the development of the Integrated Study Plans (concept sheets, project plans, protocols, CRFs, operational and analytic plans) and study summaries, IND submissions, and technical reports. Provides input to strategic decisions regarding therapeutic indications.
Oversight of the preparation of clinical portions of Immunology project INDs, IBs, CTAs, BLAs and other regulatory submissions
Authorship of abstracts and manuscripts for publication based on clinical trial data
Presentation of data and scientific information to the organization at all levels
Building relationships with opinion leaders and External alliances for partnered products when relevant
Potential for direct line management responsibility
QualificationsQualifications for the Director Clinical Development, Immunology include:MD or DO is required
Board Certification or Eligibility in relevant specialties (rheumatology or nephrology) is highly desirable
Two to five years of experience in pharmaceutical industry drug development, with a proven record of successful design, execution, close out and reporting of phase 2 and/or 3 clinical trials in immunology/inflammation area is highly desirable
Ability to work in a matrix environment with cross functional teams is essential
Strong leadership skills and the ability to influence is necessary
Approximately 15% annual travel may be required (domestic and international)
ImpactImmImmDevelopmentPrimary LocationUnited States-Pennsylvania-Spring House-Other LocationsUnited States-Massachusetts-Boston, United States-California-La JollaOrganizationJanssen Research & Development, LLC (6084)Job FunctionR&DRequisition ID2693200914
