Beschreibung
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. Remote work options may be considered on a case-by-case basis and if approved by the Company.
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.
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.
As Immunology Leaders, we know immunology is vital to human health. Driven by a relentless focus on patient unmet needs, we will redefine treatments for immune diseases by delivering transformational and accessible therapies and regimens to patients with immune-mediated disease. For more than two decades we have been a world leader in the development of transformational medicines, establishing one of the strongest, first-in-class portfolios and pipelines in the industry, including the first tumor necrosis factor (TNF) inhibitor, and first interleukin (IL)-12 and IL-23 inhibitors. We tirelessly push the boundaries of science and creativity, applying our deep disease insights, novel pathway science, new technologies, and treatment modalities to restore immune homeostasis.
Janssen Research & Development, LLC. discovers and develops innovative medical solutions to address important unmet medical needs in the following therapeutic areas: immunology, oncology, neuroscience, infectious diseases & vaccines, cardiovascular & metabolism, and pulmonary hypertension. 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. We are guided by our Credo .
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
Position Overview:
This position will serve as a Director Clinical Development for Rheumatology 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 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
Befähigungen
- MD or DO is required
- Board Certification or Eligibility in relevant specialties (Rheumatology, 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 required
- 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)
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.
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