The Director, Clinical Project Scientist will participate in investigator meetings, investigator engagement, managing sites to ensure study treatment discontinuation decisions are made per the protocol and align with stakeholders within the study team. Work with safety, data management teams, and Data Monitoring Committee to make timely decisions regarding study objectives. The CSC will assess external clinical research proposals involving Company products and manuscripts that are being prepared for publication. The CSC will also serve as a liaison between the Company and clinical research staff in many countries. The CSc will participate in the training of site and Company staff on the study protocol, ensure the clinical staff has the necessary guidance and tools for the performance of various projects.
- 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 LD 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 CSc should be capable of implementing translational medicine approaches for late clinical development.
- Reports directly to a Medical Leader/Clinical Leader for the product to which he/she is assigned.
Qualifications
- Minimum of an Advanced Degree in a Scientific discipline (i.e. M.S, Ph.D., or Pharm.D. or equivalent work experience) is required.
- A minimum of 8 years of experience in a related clinical research position is required. Spending at least part of the time within the pharmaceutical industry is preferred.
- Significant knowledge of clinical cancer research and its application to cancer drug development is required.
- Good oral and written communication skills are essential.
- Strong data analytics skills.
- Good presentation skills (including report development)
- Successful work experience in a matrix team environment with cross-functional teams is required
- This position may require up to 35% domestic and international travel depending on business needs.
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.
