Director, Clinical Science - Immunology

Johnson and Johnson is recruiting for an 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 Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/ .

Position Overview:

The focus of the Director Clinical Scientist is to support various clinical research tasks associated with assigned Immunology Development clinical trials, providing leadership in program execution, innovation, and optimization of execution. Scope of work will include responsibilities associated with the conduct, monitoring, and reporting results of clinical trials evaluating therapeutics in immuno-inflammatory disorders. The range of responsibilities may vary to some degree depending on the disease area and trial-specific requirements.

The Director Clinical Scientist is a key member of a clinical team dedicated to the development and execution of clinical strategies and the clinical and operational implementation of a complex compound program. The Director Clinical Scientist provides active scientific contribution to a cross-functional clinical team developing a molecular entity. Director Clinical Scientist will collaborate with Project Physician(s) in monitoring/leading of one or more clinical trial conduct and additionally may perform other duties. Director Clinical Scientist provides input to the clinical development plan, works on the development of the clinical trial protocol, clinical trial materials, and takes responsibility for coordinating completion of clinical study reports and supports preparation of relevant documents for regulatory filings. This role involves extensive team matrix interactions with colleagues from different disciplines. Director Clinical Scientist may be asked to contribute to the evaluation of scientific opportunities in the therapeutic area.

Responsibilities include:

• Provides clinical development expertise through the entire clinical trial process

• Performs activities which support the design, execution, monitoring, and reporting of clinical trials.

• Leads preparation of clinical development plans, trial protocols, case report forms, study operational plans

• Performs medical monitoring and reporting in partnership with Study Responsible Physician, evaluates clinical trial adverse events, reviews clinical laboratory results, drafts adverse event narratives.

• Builds credible relationships with clinical investigators, medical/scientific experts

• Partners with Clinical Operations in trial set up, conduct, recruitment activities, closeout, and reporting

• Assists Data Management with the review of clinical data and query resolution

• Works closely with Quality Management & Assurance to ensure flawless execution of clinical trials

• Drafts and coordinates completion of clinical study reports

• Drafts responses to questions from Ethics Committees and Health Authorities

• Supports integrated document development for marketing authorization filing

• Interprets, reports and prepares oral and written results of product research, in concert with senior clinical personnel, in preparation for health authority submissions

• Supports preparation for the FDA Advisory Committee and EU Oral Explanation

• Reviews medical literature and related new technologies