Janssen BioPharma, Inc. is recruiting for a Clinical Research Manager, Early Development, 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/Responsible for operational aspects of Phase 0, 1 and 2a clinical studies. Depending on complexity supervision may be warranted.
- Ability to proactively identify operational challenges in a clinical study and act accordingly to address these.
- Provides limited input into study design and facilitated/supports development of the PED
- Responsible (under supervision) for protocol development of each clinically assigned study
- May be involved in Data Review under supervision of a more experienced clinical scientists
- May lead or support financial and contract negotiations/development with third party vendors.
- Provides input in budget forecasting for each assigned clinical study
- Manages the budget for each individually assigned study
- Sets and manages timelines for each individually assigned clinical study and ensures study execution according to these.
- Provides input into selection of and manages sites and external vendors (under limited supervision if warranted).
- May participate in cross departmental work streams to enhance processes.
- Overall Impact is more on a study specific level rather than on a compound/program level.
- BS or BA with minimum 6 years of relevant professional experience in a related 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)