Director, Clinical Development

Johnson & Johnson•Titusville, NJ

54d

About The Position

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.

Requirements

MD degree or international equivalent
Active medical license
Specialty training in Psychiatry
Minimum 1 -3 year clinical/research experience in the pharmaceutical industry, relevant governmental organizations, or academic research setting required.
Ability to travel at least 30%
Ability to work in a team setting as well as function as an individual contributor
Ability to work efficiently and under tight timelines
Ability to communicate effectively
Ability to be flexible in an ever-changing environment
Ability to think strategically and be able to anticipate problems before they occur
Ability to be proactive in finding solutions to issues
Proficient in Microsoft Office (Word, Excel, PowerPoint)
Must be able to perform all essential functions of the position, with or without reasonable accommodation

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-related training as assigned within the required timelines.

Benefits

The Company maintains highly competitive, performance-based compensation programs.
Under current guidelines, this position is eligible for an annual performance bonus. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year.
Bonuses are awarded at the Company's discretion on an individual basis.
Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans.

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