Job description
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 development, strategic planning, and execution of clinical development programs in collaboration with other clinical development team members, including medical, clinical operations, translational sciences, data management, 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 to both internal and external stakeholders.
Position Responsibilities
- Clinical Study Planning and Execution
- Supports study-responsible physician (SRP) and/or lead junior clinical research scientist in execution of clinical trials.
- Participates in and leads aspects of 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 the SRP and/or lead clinical research scientist.
- 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 Good Clinical Practice (GCP).
- Collaborates 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
- Actively participates in or leads the development of Clinical Study Protocols and Protocol Amendments, Informed Consent Forms, Investigator Brochures, Development Safety Update Reports, Clinical Study Reports, Safety Review Committee charters, study plans (e.g., Medical Data Review, Medical Monitoring, Cohort Management, Protocol Deviation Plans) and publications in collaboration with the SRP and/or lead clinical scientist.
- Assists in the development and finalization of clinical content for Health Authority and IRB/EC responses.
- Clinical Data Review and Analysis
- Collaborates with lead clinical scientists, SRP, biometrics, pharmacovigilance and data management to plan and execute the analysis of clinical data.
- Conducts ongoing review of clinical data and performs critical analysis in partnership with lead clinical scientist, SRP, and data management, ensuring data integrity throughout the study.
- Identifies emerging data trends, communicates and discusses trends with SRP and pharmacovigilance scientist, when appropriate.
- Provides clinical insight to develop or update electronic case report forms (eCRFs), eCRF completion guidelines, Interactive Response Technology (IRT) specifications, patient profiles, and statistical analysis plans.
- Quality Compliance
- Collaborates cross functionally to ensure that all clinical trial activities, data, and documentation adhere to regulatory guidelines, ethical standards, and internal processes.
- Ensures 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 or otherwise are addressed promptly.
- Supports regulatory interactions by providing clear, accurate, and comprehensive data and documents for review, demonstrating adherence to compliance standards.
Candidate Requirements:
- Minimum of a bachelor’s degree in a scientific discipline or health-related field required, with advanced degree (i.e., MSc, MPH, Ph.D., or Pharm D) preferred.
- At least 5 years of drug development experience in a related clinical research position and at least part of the time within the pharmaceutical/biotech industry is required.
- Experience conducting trials in hematologic oncology is required with strong preference for experience with clinical trials for leukemia.
- Strong understanding of Good Clinical Practices (ICH/GCP), the drug development process, and the design and conduct of clinical trials.
- Fluent in written and spoken English with excellent oral and written communication skills
- Ability to critically review, synthesize and present data.
- Ability to interact with associates at all levels to coordinate and execute study activities in a fast-paced small biotech environment.
- High performing and energetic individual with a passion for and dedication to clinical research and advancement of potential new treatments for patients.
Location
- This position may be remote (East Coast) or based at our corporate office in Cambridge, MA.
Cullinan Therapeutics is proud to be an Equal Opportunity Employer. We are committed to creating an inclusive and diverse environment for all employees and applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.
