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