Sr. Clinical Research Scientist /Associate Director, Clinical Research Scientist
United States
Clinical /
Remote /
Remote
Cullinan Therapeutics, Inc. (Nasdaq: CGEM) is a biopharmaceutical company dedicated to creating new standards of care for patients.
We have strategically built a diversified portfolio of clinical-stage assets that inhibit key drivers of disease or harness the immune system to eliminate diseased cells in both oncology and autoimmune disease. Our portfolio encompasses a wide range of modalities, each with the potential to be best and/or first in class.
Anchored in a deep understanding of oncology, immunology, and translational medicine, we create differentiated ideas, identify the most appropriate targets, and select the optimal modality to develop transformative therapeutics across a wide variety of cancer and autoimmune indications.
We push conventional boundaries from candidate selection to differentiated therapeutic, applying rigorous go/no go criteria at each stage of development to fast-track only the most promising molecules to the clinic and, ultimately, commercialization.
With deep scientific expertise, our teams exercise creativity and urgency to deliver on our promise to bring new therapeutic solutions to patients.
Summary:
The Clinical Research Scientist participates in the execution of clinical development programs in collaboration with other clinical development team members, including medical, clinical operations, translational sciences, and regulatory affairs. The Clinical Research Scientist will play an essential role in developing clinical and regulatory documents, reviewing scientific and clinical data, and communicating data both within the company and outside scientific and medical audiences.
Position Responsibilities:
- Clinical Study Planning and Execution
- Supports lead clinical research scientist and/or study-responsible physician (SRP) in formulating clinical development plans and study designs.
- Participates in protocol training for site initiation and investigator meetings in collaboration with clinical operations.
- Reviews and adjudicates study subject eligibility and protocol deviations and responds to specific site protocol questions, working closely with senior level clinical research scientist and/or SRP.
- Identifies scientific and/or clinical quality issues to discuss with investigator and study sites and escalates as appropriate to the quality team to ensure compliance with GCP.
- Collaborate effectively with internal cross-functional teams and external CRO partners to ensure the successful achievement of study goals, including meeting enrollment milestones and generating high-quality data
- Clinical Document Development
- Contribute to development of clinical study protocols, Informed Consents Forms, investigational brochure, DSUR, and Clinical Study Report, SRC charter and Medical Monitoring Plan
- Assists in the preparation of clinical content for regulatory submissions/documents (briefing document and NDA)
- Clinical Data Review and Analysis
- Collaborates with senior-level clinical scientists, SRP, biometrics, and data management teams to plan and execute the analysis of clinical data.
- Conducts ongoing clinical data review and performs critical analysis in partnership with senior-level clinical scientists, SRP, and data management, ensuring data integrity throughout the study.
- Provides clinical science-related contributions to developing case report forms (CRFs), CRF completion guidelines (CCGs), and statistical analysis plans.
- Quality Compliance
- Collaborate cross functionally to ensure that all clinical trial activities, data, and documentation adhere to regulatory guidelines, ethical standards, and internal processes
- Ensure that clinical trial sites, documents, and data are always audit-ready. This includes maintaining thorough, organized documentation and ensuring that any findings from internal or external audits are addressed promptly.
- Support regulatory inspections by providing clear, accurate, and comprehensive data and documents for review, demonstrating adherence to compliance standards.
Candidate Requirements:
- Advanced degree in life sciences and/or health-related field, with 5+ years of drug development experience or bachelor’s level education with equivalent working experience
- Basic knowledge of medical oncology and oncology clinical trials including RECIST Criteria
- Strong understanding of Good Clinical Practice, the drug development process, and the design and conduct of clinical trials. Experience in conducting trials in oncology will be preferred
- Excellent written and verbal communication skills
- Ability to interact with staff at all levels to coordinate and execute study activities in a fast-paced small biotech environment
- Passion and dedication to clinical research
