What are the responsibilities and job description for the Director, Clinical Development, Immunology position at Johnson & Johnson?
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.
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 .
This position will serve as a Director for Clinical Immunology products in development with indications in pediatric Immunology or Gastroenterology. The position will support overall strategy in their field of expertise, as well as carry accountability for protocol design, development and execution. In addition, the incumbent would be expected to have input in regulatory interactions and document writing.
The Director responsibilities will include:
- Provides significant strategic input to pediatric drug development group
- Provides scientific & clinical leadership to pediatric clinical trial teams.
- Responsible for design, execution, and reporting of Phase 1,2 and 3 pediatric clinical trials.
- Responsible for monitoring safety of clinical trials and providing scientific leadership in the area of responsibility.
- Leads 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.
- Serves as the Clinical Lead for pediatric studies, accountable for study deliverables
- Collaborates with early and late development clinical teams and Compound Development Teams to align pediatric strategy
- Oversees 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.
- Presents data and scientific information to the organization at all levels.
- Builds credible relationships with opinion leaders and External alliances for partnered products when relevant
- Potential for direct line management responsibility
Qualifications
Qualifications for the Director Clinical Development, Immunology include:
- MD or DO is required
- Board Certification or Eligibility in Pediatrics or Pediatric subspecialty (Immunology, Rheumatology, Dermatology, Gastroenterology) is highly desirable
- Experience in pharmaceutical drug development or clinical research (academic or industry setting) 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 10% annual travel may be required (domestic and international)
