Job Information
J&J Family of Companies Director, Clinical Research - Immunology in Belgium
Director, Clinical Research - Immunology - 2406193099W
Description
Johnson and Johnson is recruiting for a Director Clinical Development; Immunology Therapeutic Area, to be located in Spring House, PA. Remote work options may be considered on a case-by-case basis and if approved by the Company.
At 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.
Johnson & Johnson 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 Johnson and Johnson. 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.
Johnson and Johnson Immunology has a history of bringing life-changing therapies to patients with immune-mediated diseases.
Position Overview:
This position will serve as a Director Clinical Development for Rheumatology, Rare, Maternal Fetal 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 Rheumatology, Rare, Maternal Fetal Immunology Therapeutic Area disease portfolio
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
Qualifications
Qualifications - External
MD or DO is required
Board Certification or Eligibility in relevant specialties (internal medicine, neonatology, maternal fetal medicine, OB/GYN, hematology) is highly desirable
At least two 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 is required
Experience in rare disease drug development is highly desirable
In-depth understanding of and proven success in how to conceptualize, design, and conduct complex, global clinical trials
Proven ability to lead, manage, and motivate others in a complex, multi-functional matrix environment is essential
Understanding of regulatory agency organization, guidelines, and practices and ability to negotiate with these groups
Knowledge of Good Clinical Practices, FDA regulations and guidelines, and applicable international regulatory requirements
Strong leadership skills and the ability to mentor and influence is necessary
Approximately 15% annual travel may be required (domestic and international)
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
#ImpactIMM
Primary Location NA-US-Pennsylvania-Spring House
Other Locations Europe/Middle East/Africa-United Kingdom, Europe/Middle East/Africa-Netherlands, Europe/Middle East/Africa-Belgium
Organization Janssen Research & Development, LLC (6084)
Relocation Eligible: Yes - Within Country
Job Function Clinical Development & Research & MD
Req ID: 2406193099W