Senior Clinical Research Scientist II

This is a fully remote position, open to applicants in California.

📋 Description

• Oversee the execution of clinical studies, including planning, conducting, data evaluation, and reporting for Phase I and II trials focused on hematologic malignancies.

• Take responsibility for ongoing clinical data assessments, ensuring patient safety and data integrity; identify trends and promote decisions based on data insights.

• Lead activities related to safety monitoring, including the review of adverse events and CAR-T related toxicities (e.g., CRS, ICANS) and assist in making dose escalation decisions.

• Foster cross-functional collaboration with Clinical Operations, Translational Sciences, Data Management, Biostatistics, Regulatory, and CMC teams to guarantee high-quality execution of studies.

• Author key study documents, such as protocols, Investigator’s Brochures, clinical study reports, regulatory submissions, and safety narratives.

• Combine clinical and translational data (e.g., cell expansion, persistence, biomarker data) to derive insights and guide program strategy.

• Contribute to the regulatory strategy and submissions, including documents related to IND and responses to health authorities.

• Act as the scientific lead at the study level, collaborating with investigators, CROs, and key opinion leaders.

• Assist in the creation of publications, abstracts, and presentations intended for scientific conferences.

• Ensure adherence to GCP, internal SOPs, and regulatory standards.

⛳️ Requirements

• PhD/PharmD with over 5 years of experience in clinical development; MA/MS/MSN with more than 8 years of experience; or BA/BS/BSN with at least 10 years of experience.

• Background in drug development for hematology-oncology.

• Experience in CAR-T or cell therapy development.

• Proven track record of managing clinical studies, preferably in early phase trials.

• Excellent scientific writing and communication abilities.

• Familiarity with GCP and regulatory requirements.

• Experience in clinical data review and interpretation (including data listings).

• Capability to analyze and synthesize complex clinical and biomarker data.

• Willingness to travel 30% of the time based on business requirements.

🏝️ Benefits

• Comprehensive compensation package that includes a competitive salary, bonuses, and equity for all employees.

• Generous paid vacation time, in addition to holidays recognized by the company.

• Excellent medical, dental, and vision insurance coverage.

• 401(k) retirement savings plan with employer matching contributions.

• Employee stock purchase plan (ESPP).

• Tuition reimbursement program.