Director, Clinical Development

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

Job Function:

Discovery & Pre-Clinical/Clinical Development

Job Sub Function:

Clinical Development & Research – MD

Job Category:

Scientific/Technology

All Job Posting Locations:

Titusville, New Jersey, United States of America

Job Description:

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/.

Johnson & Johnson has entered into an agreement to acquire Intra-Cellular Therapies, Inc, a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders.  With a differentiated commercialized therapy and promising clinical-stage pipeline that complements our current areas of focus, this acquisition brings us one step closer to achieving our ambition of becoming the #1 neuroscience company worldwide.

Intra-Cellular Therapies, a Johnson & Johnson company, is on the path to be the #1 leader in neuroscience. With an exceptional suite of products and a commitment to transforming patient lives, we are expanding our CAPLYTA® Marketing team to support our growing impact in the marketplace.

Director, Clinical Development, will be responsible for the leadership, oversight, and medical integrity of psychiatry studies/programs. This individual will monitor clinical studies, review and interpret clinical trial data,

provide input into clinical study and regulatory communications and reports, and contribute to clinical development plans and strategy. A candidate for consideration has been pre-identified. However, all qualified applications will be reviewed.

Job Responsibilities

• Provide cross functional Clinical Development leadership for internal and external team members in the delivery of clinical studies:

  • Provide a role in the strategic planning of clinical studies and programs, including the development of study design, milestones, key deliverables.

  • Provide support and oversight to all other functional areas of the study teams throughout the lifecycle of the study (startup, maintenance, closeout) in order to ensure data integrity, resolve and/or escalate issues, achieve alignment, and adhere to study goals and timelines.

  • Act as primary contact for medical communication to ensure medical safety within studies. Develop and maintain relationships with sites and Investigators.

  • Provide medical monitoring, which includes reviewing study participant eligibility, protocol interpretation, coding support, protocol deviation review, and data cleaning in collaboration with Clinical Operations and Data Management.

  • Work with Biometrics to contribute to the analysis and interpretation of clinical results.

• Author, review, and/or provide strategic input into:

• Clinical sections of regulatory documents including, IND submissions, annual updates, DSUR, investigator brochures, and briefing documents.

• Study specific documents such as study protocols/amendments, informed consent documents, case report forms, placebo justifications, and clinical study reports.

• Scientific publications, manuscripts, posters, or other documents intended for external audiences.

• Represent Clinical Development at Regulatory Authority Meetings.

• Present the clinical development aspects of a project and clinical trial results at internal or external meetings.

• Communicate to Senior Management and relevant functions any potential issues, risks or changes to the Clinical Development Plan.

• Complete all company and job-