HireDiversity

Raritan, NJ, US

Director, Clinical Project Scientist-1002130206

Description

Janssen Research & Development, LLC. is recruiting for a Director, Clinical Project Scientist, to be located in Raritan, NJ, or Spring House, PA.

Janssen Research & Development, Inc. develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, oncology, infectious disease, diabetes, hematology, metabolic disorders, and immunologic disorders.

Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.

The Director, Clinical Project Scientist develops and drives the goals and activities of the Clinical Research department such as designing, planning, developing and monitoring of clinical evaluation projects. This person is Responsible for the compliance of department, company and regulatory standards and procedures. The Director, Clinical Project Scientist Executes clinical research strategies and contributes to the development and execution of clinical research programs for company products; Directs study design, protocol development and implementation of clinical studies including late-phase development. Ensures that all activities are in compliance; Defines clinical study parameters, deliverables, policy compliance and resource needs; Evaluates the company clinical work to determine marketability of products; Helps explore and evaluate new product ideas to assist in identifying new marketing opportunities; Serves as a medical liaison and consultant for marketing efforts; Interfaces with key members of drug discovery team to contribute to success of portfolio; Reviews and evaluates results of phase 1-4 investigations in preparation for new drug application to the regulatory agencies; Acts as a liaison between company and clinical investigators; Develops credible relationships with opinion leaders, medical directors, and key regulatory officials; Performs medical monitoring/reporting and company safety officer activities; Evaluates adverse events (pre and post-marketing) and Approves and monitors the annual operating and capital budgets.

J2W:LI

Qualifications


A minimum of a Bachelor's degree is required. An Advanced degree is preferred. A minimum of 8 or more years of clinical research and development within the industry (pharmaceutical, biotech, CRO, etc) is required. Experience in oncology therapeutic area is required. Significant experience with clinical development programs, from design to execution, including development of protocols through to close out and submission, is highly desired. Excellent written communication, oral communication, and presentation skills are required. The individual must have demonstrated ability to work in a team environment. Ability to travel up to 10% required.

BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

Primary Location:North America-United States-New Jersey-Raritan
Other Locations:North America-United States-Pennsylvania-Spring House
Organization: Janssen Research & Development, LLC. (6084)
Job Function: Clinical Research MD