Janssen BioPharma, Inc. is recruiting for an Associate Director, Early Clinical Science, located in South San Francisco, CA.
The Early Clinical Scientist (eCS) is a responsible member of the early development team, dedicated to the development and execution of the clinical and translational strategy (scientifically, clinically, and operationally) in Early Development. The eCS contributes to protocol development, data review and study reporting and oversees execution of early clinical studies in a timely and cost-effective manner. The eCS supports external collaboration, implements TA specific innovative projects and translational/reverse translational strategy, and explores newly defined disease area and technology development opportunity.
eCS is also an integral part of Discovery Project Team to enable seamless bridging, consistency and continuity throughout lead drug discovery and early clinical development.
- Accountable for the planning and execution process for early clinical studies including Phases 0, 1 and 2a
- Act as Therapeutic Area Point of Contact for internal and external partners for assigned clinical project
- Lead Clinical Working Groups as assigned to deliver trials on schedule and budget
- Provide input into study design and develop PED with minimal supervision. Responsible for full protocol development for assigned clinical project
- Drive the translation of development strategy into study concepts and execution under limited supervision of the clinical leader.
- Take part in review and analysis of study data with limited supervision; Organize and manage Data Review Committee meetings as applicable
- Contribute to the scientific and operational content of clinical development related documents such as status reports, IB, CSR, Briefing Book for management and project team
- Lead external research collaboration and innovation projects in support of the clinical leader.
- Accountable for vendor performance and relationship management.
- Provides input to budget forecasting for a compound/program; Responsible for the budget and timeline
- BS or BA with minimum 8 years of relevant professional experience in a relevant scientific discipline (advanced degree in scientific field a plus)
Experience and Skills:
- Knowledge of FDA regulations, ICH guidelines, and GCPs governing clinical trials
- Experience in clinical development and operations (early development a plus)
- Excellent partnership, communication, decision-making and organizational skills; Good project management skills
- Familiarity with key clinical research processes, including protocol development, trial execution, data management/data review and report writing
- Demonstrated ability to lead multiple tasks concurrently and to prioritize tasks effectively
- Ability to handle complex projects and to overcome delays and obstacles
- Ability to influence and negotiate with colleagues in a supportive and constructive fashion
- Be flexible and adaptable to the needs of the business
- Laboratory research experience a plus
- Willingness and ability to travel up to 10%
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-California-South San Francisco-
Janssen BioPharma, Inc. (6224)