Janssen Pharmaceutical, a member of Johnson & Johnson's Family of Companies, is recruiting for multiple Director, Clinical Project Scientists, Solid Tumors- Clinical Development, Oncology. These position(s) will be located in Spring House, PA, Raritan, NJ or La Jolla, CA.
At the Janssen Pharmaceutical Companies of 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 Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
The Director, Clinical Project Scientist develops and drives the goals and activities of Clinical Research department such as designing, planning, developing and monitoring of clinical evaluation projects. Interprets research results and evaluates the safety, marketability and medical usefulness of drug and product candidates. Responsible for the compliance of department, company and regulatory standards and procedures.
Primary Responsibilities Include:
Executes clinical research strategies and contributes to the development and execution of clinical research programs
Directs study design, protocol development and implementation of clinical studies
Defines clinical study parameters, supports deliverables, policy compliance and resource needs
Serves as a clinical representative for cross functional workstreams
Reviews and evaluates results of clinical trial data 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, evaluates ongoing clinical trial data
Manages and provides oversight on trial results
Assists with development of clinical research protocols, study case report forms, informed consent and drug projections
Organizes documentation needed for data collection, analysis
Reviews and maintains correct standard operations, procedures and protocol
Can interpret results of clinical trial data in preparing new drug applications to the appropriate governmental body
Guides and mentors less experienced team members in adherence to clinical research guidelines and safety procedures
Maintains expertise on clinical trial documentation, requirements, regulations, operational procedures, study file requirements, regulatory requirements, policies
Crafts essential conditions that are necessary to determine the safety, efficacy, medical usefulness, and marketability of drug and product candidates
Communicates detailed outcomes and results of research findings to relevant partners;
Provides input in managing project budgets and projections
Completes relevant registration, submissions and reports
Serves as liaison to clinical sites and other vendors, as well as internal/external customers;
Presents research status at internal/external meetings, including investigator meetings and company sponsored events
Assists with interactions with health authorities
Bachelor's degree required. An advanced degree (MS, MSN, RN, PharmD, PhD) preferred.
A minimum of 8 years of progressively responsible experience in clinical research and development, or related experience within the industry (pharmaceutical, biotech, CRO, etc.) is required.
Experience in oncology therapeutic area is required.
Significant experience with clinical trials including development of protocols, case report forms, informed consent, study initiation, protocol training, and clinical data monitoring required.
Excellent written communication, oral communication, and presentation skills are required.
The individual must have demonstrated ability to work and lead in a cross-functional team environment and be flexible and adaptable.
Ability to travel up to 10% required.
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.
United States-Pennsylvania-Spring House-Welsh & McKean Roads
North America-United States, United States-New Jersey-Raritan, North America-United States-California-La Jolla
Janssen Research & Development, LLC (6084)
Johnson & Johnson