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.
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 .
Janssen Immunology applies actionable scientific insights to unmet medical needs, to deliver transformational and accessible therapies that restore immune balance, health, and remission for patients with Immune-Mediated Inflammatory Disease (IMID).
This position will serve as a Director for Clinical Immunology products in development, including indications in Dermatology. The Director will collaborate with other members of the Late Development organization and key partner groups, including Translational Science & Medicine, Compound Development Teams, Clinical Operations, Regulatory, Global Medical Safety, and Disease Area Strongholds, to advance our portfolio.
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.
Responsibilities include :
- Clinical development strategies for assets in the portfolio
- Design, execution (including medical monitoring), analysis, and reporting of Phase 2 and 3 clinical trials in Immune-Mediated Inflammatory Diseases (IMID) including in dermatology
- Medical monitoring of clinical trials
- Providing clinical expertise and scientific leadership in the areas of responsibility
- Providing expert clinical input to strategic decisions regarding therapeutic indications
- Leading the development of integrated study plans, including concept sheets, project plans, protocols, CRFs, operational and analytic plans.
- Oversight of the preparation of clinical portions of Immunology project INDs, IBs, CTAs, NDAs, BLAs, and other regulatory interactions.
- Authorship of abstracts and manuscripts for publication based on clinical trial data
- Presentation of data and scientific information to the organization and externally at all levels
- Building relationships with opinion leaders and through external alliances for partnered products when relevant
- Potential for direct line management responsibility
- Approximately 10% annual travel may be required (domestic and international)
The successful candidate will have a passion to drive programs into diverse immune-mediated inflammatory disease indications, based on scientific rationale and unmet medical needs.
- High degree of curiosity, creativity, learning and change agility
- Looks beyond information to anticipate, develop, and convey implications, options, recommendations
- Strong communication and entrepreneurial skills
- Ability to build and foster collaborative relationships
- Strong capacity to work, lead, and influence in a matrix environment
- Can represent Janssen and the Immunology TA with professionalism and integrity both internally and externally
- MD or DO is required
- Experience (pharmaceutical industry or academic / clinical) in design, execution, analysis, reporting of phase 2 / 3 clinical trials, ideally for immune-mediated inflammatory diseases in dermatology or related disease areas
- Board Certification / Eligibility (or equivalent) in dermatology is desirable
United States-Pennsylvania-Spring House-Welsh & McKean Roads
North America-United States-California-La Jolla, North America-United States-Massachusetts-Boston
Janssen Research & Development, LLC (6084)