Fate Therapeutics, Inc.
Clinical Scientist
San Diego, CA · Full-time
Sponsorship not specified$130k-$150kDetected 11 days ago
GCPStatisticsForecastingRecruitingICD-10Clinical TrialsFDA RegulatoryExperimental DesignLeadershipCommunicationProblem SolvingPublic SpeakingRegulatory Affairs
About the role
- Fate Therapeutics is seeking a scientifically rigorous and highly motivated Clinical Scientist to join our Clinical Development team.
- The Clinical Scientist will play a key role in advancing our pipeline of highly innovative cell therapies from early clinical development through regulatory approval.
- 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.
- Stay current on standards of practice within relevant therapeutic areas to support strategic discussion and decision-making for the program.
- 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.
- 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.
Requirements
- 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.
- 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.
- 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.
- Travel may be required (up to 10%).
- Additional and incidental duties related to the primary duties may be required from time to time.
- 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.
- 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
- 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.
Benefits
- 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.
Equal opportunity
- Fate Therapeutics, Inc. is an equal opportunity employer.
- We value diversity and are committed to creating an inclusive environment for all employees.
- About Fate Therapeutics, Inc.
- Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to bringing a pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients.
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