Director, Clinical Development - Spring House, United States - Johnson & Johnson

Johnson & Johnson

Verified Company

Spring House, United States

3 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

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.

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.

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