The Clinical Scientist will play a key role in advancing our pipeline of highly innovative cell therapies from early clinical development through regulatory approval. As a key scientific partner to the clinical study team, the Clinical Scientist will support the design, execution, and interpretation of clinical studies while ensuring the highest standards of ethical conduct, patient safety, and adherence to GCP compliance. This key member of the clinical team will collaborate closely with cross-functional teams, including Clinical Operations, Regulatory Affairs, Medical Writing, and Biometrics, to advance clinical programs. This is a full-time, exempt position located at our corporate headquarters in San Diego, CA.
Responsibilities- Collaborate in the review, analysis, and interpretation of emerging study data from clinical trials across the program, ensuring data integrity and study conduct is performed with the highest level of ethical and safety standards and in compliance with all regulatory requirements.
- Partner with the study team to develop key strategic documents, including eCRFs, clinical study plans, protocols and reports.
- Contribute to the review and presentation of clinical sections of regulatory documents including Investigators' Brochures, briefing books, safety updates, IND/NDA submission documents, study protocols, informed consents, statistical analysis plans, regulatory approval submissions, serious and non-serious adverse event evaluation, and responses to Health Authorities inquiries.
- Stay current on standards of practice within relevant therapeutic areas to support strategic discussion and decision-making for the program.
- Support data review activities including ongoing data cleaning through database lock, ensuring safety and response data reconciliation, review of medical coding of adverse events, laboratory data and concomitant medications for accuracy, coherence, consistency, and trends, and review of data tables, listings, and figures; and clinical study reports.
- Develop effective working relationships with key investigators and coordinators to optimize scientific quality and innovation of clinical study design, execution, reporting and publications.
- Support the contributions to meetings for trial-related advisory boards, investigators, safety monitoring, and study team training.
- Coordinate with internal and external study teams the real time availability of quality clinical trial data, including safety, efficacy, pharmacokinetic and biomarker data, to provide consolidated information for Senior Management.
- Assist in forecasting trial resource needs (internal and external).
Qualifications- MS, RN, PhD, or PharmD with a minimum of 3 years technical and/or operational experience in planning, executing, reporting, and publishing clinical studies in a biotech, pharmaceutical, or CRO environment.
- Experience in the design and conduct of oncology or autoimmune clinical trials is desirable.
- Experience in novel combinations and innovative designs for early phase studies.
- Proven experience writing and presenting scientific communications with clarity, accuracy, and rigor.
- Experience with U.S. and European regulatory authorities and submissions is desirable.
- Experience or exposure to the development of cell therapies is desirable.
- Self-motivation, good judgment, strong follow up, organizational, analytical, and problem-solving skills; capable of identifying risks; creative and innovative thinker.
- Ability to work with, lead, and motivate a cross-functional matrix team.
- Excellent written and oral communication skills. Ability to communicate effectively with cross-functional teams and through formal presentation and scientific discussion ensuring credibility, accuracy, and confidence with internal and external stakeholders and experts.
Working conditions & physical requirements- Travel may be required (up to 10%).
- Subject to extended periods of sitting and standing, vision to monitors, and moderate noise levels.
Compensation- The salary offer will be based on a variety of factors, including level, experience, qualifications, internal equity, and location.
- Fate offers a competitive employment package that includes an annual bonus, equity, and a generous benefits package.
- The anticipated salary range for this role is $130,000 - $150,000.
The preceding job description indicates the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required from time to time.
