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Clinical Scientist

Fate Therapeutics, Inc.

Fate Therapeutics, Inc.fatetherapeutics,inc..com

Clinical Scientist

Posted 1 week ago

About the job

Fate Therapeutics is a biotech company developing iPSC-derived cellular immunotherapies. The Clinical Scientist focuses on clinical trial design, data interpretation, and regulatory collaboration in a full-time role at our San Diego headquarters.

Requirements

  • 3+ years clinical research experience
  • Experience in biotech or pharma
  • Knowledge of regulatory submissions
  • Strong analytical skills
  • Excellent communication skills

Qualifications

  • MS, RN, PhD, or PharmD
  • Experience in oncology or autoimmunity
  • Regulatory authority knowledge
  • Team leadership ability
  • Experience with cell therapies

Full job description

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. 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.

    Equal Employment Opportunity

    Fate Therapeutics, Inc. is an equal opportunity employer. We value diversity and are committed to creating an inclusive environment for all employees.

    Privacy Notice

    To learn about how Fate collects and uses job application information, please visit Fate's online Privacy Notice.

    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. Using its proprietary iPSC product platform, the Company has established a leadership position in creating multiplexed-engineered master iPSC lines and in the manufacture and clinical development of off-the-shelf, iPSC-derived cell products. The Company’s pipeline includes iPSC-derived T-cell and natural killer (NK) cell product candidates, which are selectively designed, incorporate novel synthetic controls of cell function, and are intended to deliver multiple therapeutic mechanisms to patients. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com.

    ⚠️ Recruitment Fraud Alert

    Recently, we have been made aware of unauthorized individuals falsely presenting themselves as Fate Therapeutics employees or recruiters as part of online scams or phishing attempts. Impersonators may use the Fate Therapeutics name and logo, as well as employee names and job titles, to gain a job seeker’s personal or banking information or to request payment as a condition of being considered for a position at the company. Fate Therapeutics and its employees are not involved in these scams.

    Here are a few things to be aware of to help identify recruitment fraud:

    - Our Talent Acquisition team only corresponds from our @fatetherapeutics.com domain.

    - At no stage in our hiring process will we require payment or ask you to make deposits in your bank account.

    - We will only ask for personal information when applying for a position via our Careers page or thereafter.

    - At no stage during our hiring process will we ask you to click a link to begin a one-way video interview.

    - We do not use Google Hangouts, WhatsApp, or other third-party messaging platforms to recruit candidates or conduct interviews.

    Please exercise caution. If something feels off about your interactions, we encourage you to contact us at careers@fatetherapeutics.com to confirm the authenticity of the message. Your security is important to us, and we appreciate your vigilance.

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