Job Description

Janssen Research and Development, L.L.C., a member of Johnson & Johnson's Family of Companies, with a specific focus on the field of Oncology, has a position for a Director, Clinical Project Scientist in the Oncology Therapeutic Area. The preferred location for this position is Boston, Massachusetts, but consideration will be given to other locations (Raritan, NJ, Spring House, PA, or remote). Up to 15% domestic and international travel is required.

The current position is in Late Development (LD) and requires supporting a Late-Development Compound program, specifically running phase 2-3 cancer studies, supporting the Study Responsible Physician (SRP). As part of the role, collaborating with the SRP and the Molecule Responsible Physician (MRP), the Clinical Project Scientist assists in the preparation of protocol writing for and operational execution of clinical studies. The Clinical Project Scientist participates in the start-up of global clinical studies, ensuring on schedule site activation and subject enrollment, monitoring, compliance with department safety practices, policies, procedures as well as the day to day management of a clinical trial. Furthermore, the Clinical Project Scientist will implement clinical study parameters, deliverables, policy compliance and resource needs, apply scientific discipline to minimize risk and increase performance, play a key role in the medical review of study data and timely and high-quality data entry and assist in coding, analysis and documentation of Company clinical work.

The Director, Clinical Project Scientist will participate in investigator meetings, investigator engagement, managing sites to ensure study treatment discontinuation decisions are made per protocol and align with stakeholders within the study team. Work with safety, data management teams and Data Monitoring Committee to make timely decision regarding study objectives. The Clinical Project Scientist will assess external clinical research proposals involving Company products and manuscripts that are being prepared for publication. The Clinical Project Scientist will also serve as a liaison between the Company and clinical research staff in many countries. The Clinical Project Scientist will participate in the training of site and Company staff on the study protocol, ensure the clinical staff have the necessary guidance and tools for performance of various projects.

Essential Responsibilities:

High-performing and energetic individual who demonstrates outstanding scientific knowledge applicable to oncology clinical research and the highest personal and ethical standards.
Must be equally comfortable among the team to which he/she is assigned and in the global environment in which the Company operates. The program is in an accelerated development mode and experience with registrations studies will be highly valued.
Require capabilities to work on additional Late Development studies moving into operation in later years. This will involve close interaction and working closely with the discovery, biomarkers, clinical pharmacology, companion diagnostic development team, regulatory, statistics and operations.
Understanding how these various functions work, the Clinical Project Scientist should be capable of implementing translational medicine approaches for late clinical development.

Qualifications
* Advanced Degree in a Scientific discipline (i.e. M.S, Ph.D. or Pharm.D. or equivalent work experience) is required
* A minimum of 6 years of clinical research and development, or related experience within the industry (pharmaceutical, biotech, CRO, etc.) is required.
* Experience in oncology therapeutic area is preferred.
* Significant experience with clinical evaluation projects including development of protocols, case report forms, informed consent and study initiation and monitoring preferred.
* 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 15% 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.

Primary Location
United States-Pennsylvania-Spring House-Welsh & McKean Roads
Other Locations
United States, United States-Massachusetts-Lexington, United States-New Jersey-Raritan
Organization
Janssen Research & Development, LLC (6084)
Job Function
R&D;
Requisition ID
2105895846W