DIRECTOR, CLINICAL DEVELOPMENT - PEDIATRIC IMMUNOLOGY

Johnson and Johnson is recruiting for a Director, Clinical Development, Immunology to be located in Spring House, PA.
Candidates could also be based in our Cambridge or La Jolla facilities.
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 and 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.
anssenrnd.
om/ 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.
This position will serve as a Director for Clinical Immunology products in development with indications in pediatric Immunology, Rheumatology, Infectious Disease, Dermatology, or Gastroenterology.
The position will support overall strategy in their field of expertise, as well as 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.
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, Infectious Disease, 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) 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