Clinical Scientist

About the role

The role of Clinical Scientist at Fate Therapeutics involves driving the strategic scientific direction of early cell therapy programs. You will own the design and execution of clinical development plans, ensuring they are both scientifically sound and operationally feasible. This position requires you to act as a primary scientific authority within the clinical team, making critical decisions that impact trial integrity and patient safety. You will translate complex cellular therapy concepts into actionable and compliant study frameworks. The successful candidate will serve as a key liaison between scientific objectives and regulatory requirements. This role demands a high level of autonomy and judgment in navigating clinical development challenges. Ultimately, you will be responsible for advancing the clinical program toward successful regulatory authorization.

Key facts

What you'll do

• Lead the strategic planning and scientific design of early-phase clinical studies from initial protocol drafting through final database lock.
• Serve as the primary scientific expert within the clinical development team, making final determinations on study feasibility and participant safety considerations.
• Design and implement robust study frameworks that precisely align therapeutic objectives with operational capacity and regulatory expectations.
• Construct detailed clinical execution timelines and coordinate cross-functional resource allocation to ensure timely study initiation and milestones.
• Analyze complex safety data and pharmacodynamic readouts, interpreting multifaceted information to recommend protocol adjustments and study optimizations.
• Champion the protection of participant welfare by proactively identifying and escalating safety signals and adverse events to ensure vigilant oversight.
• Draft comprehensive study reports and regulatory submission documents, ensuring clarity, accuracy, and alignment with evolving compliance standards.
• Collaborate with Clinical Operations to synchronize study timelines, deliverables, and operational workflows across the development team.
• Partner with Regulatory Affairs to ensure all submissions and protocols adhere to current guidelines and evolving regulatory landscapes.
• Work with Medical Writing to develop precise, scientifically rigorous protocols that clearly articulate study methodologies and objectives.
• Liaise with Biometrics teams to validate statistical analysis plans, ensuring models are appropriate for the cellular therapy data and patient populations.
• Provide expert guidance on regulatory submissions, verifying that all materials meet Good Clinical Practice (GCP) and authority requirements.
• Assess emerging clinical data trends and translate findings into actionable insights that inform future patient care strategies and development plans.
• Monitor program health across all active studies, ensuring consistent adherence to ethical standards and GCP principles.

Requirements

• Hold a doctoral degree in Life Sciences, Medicine, or a closely related scientific field.
• Possess a minimum of three to five years of progressive experience in clinical science, with preference for cellular therapy backgrounds.
• Demonstrate a thorough understanding of cellular therapy development pathways, including IND-enabling studies and regulatory frameworks.
• Exhibit a strong commitment to adhering to Good Clinical Practice (GCP) guidelines and ensuring the highest level of participant protection.
• Show proven ability to operate effectively in a fast-paced, dynamic biotechnology environment.
• Have extensive experience interpreting complex clinical data to inform scientific decision-making and protocol modifications.
• Display exceptional written and verbal communication skills for engaging with cross-functional stakeholders at all organizational levels.
• Proficient in the use of Microsoft Office Suite and common data management platforms to analyze and present scientific information.
• Possess strong project management abilities to coordinate timelines, dependencies, and cross-team dependencies independently.
• Maintain a meticulous attention to detail to ensure accuracy in documentation, data analysis, and regulatory submissions.
• Demonstrated understanding of ethical principles and regulatory compliance specific to clinical research involving human subjects.
• Ability to manage multiple priorities simultaneously while maintaining a high standard of quality and organization.
• Willingness to travel domestically for meetings, conferences, or operational needs as required by the role.
• Must be authorized to work in the United States without sponsorship for this position.

Nice to have

• Experience with IND applications and interactions with regulatory authorities such as the FDA.
• Familiarity with immuno-oncology or cellular therapy trial designs and methodologies.
• Knowledge of statistical programming tools commonly used in clinical data analysis.

Practical notes

• Work

Location: On-site at the San Diego, California headquarters is required for this role.

-

Employment Type: This is an Exempt, full-time position.

• Travel: Domestic travel may be required for meetings, conferences, or operational duties.
• Visa Sponsorship: This role does not offer visa sponsorship. Candidates must have current authorization to work in the United States.