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.

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.

This position will serve as a Director of Clinical Development for Immunology Therapeutic Area products, with a focus on Gastroenterology. 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 immunology/autoimmune 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 the 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, case report forms [CRFs], operational and analytic plans) and study summaries, Investigational New Drug (IND) submissions, and technical reports. Provides input to strategic decisions regarding therapeutic indications.
• Oversight of the preparation of clinical portions of Immunology project INDs, Investigator Brochures (IBs), Clinical Trial Applications (CTAs), Biologics License Applications (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

• In collaboration with Compound Development and Disease/Pathway Area Stronghold teams, development/execution of:
  • Disease/pathway area strategies including indication/target prioritization, future treatment paradigms incorporating treatment sequences and combinations, precision medicine/patient stratification
  • Novel outcome measures for inclusion in clinical trials/practice/labelling
• Medical/scientific responsibility in business development activities, including assessment/due diligence for external program/asset partnering opportunities
• Participate in cross-departmental/cross-functional projects with broad Janssen impact

Qualifications

Qualifications for the Director Clinical Development, Immunology include:

• MD or DO is required
• At least two (2+) 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
• Board certification or eligibility in relevant specialties (Gastroenterology or Allergy & Immunology) 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 10-20% annual travel may be required (domestic and international)

For US based candidates - The anticipated base pay range for this position is $186,000 to $322,000

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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