Director/Sr. Director, Clinical Research Scientist

Cullinan Oncology

Cullinan Oncology

United States
Posted on Wednesday, May 22, 2024
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, 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
  • Assists the 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 the 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.
  • Clinical Document Development
  • Leads development of clinical study protocols, investigational brochure, and informed consent form
  • Assists in the preparation of clinical content for regulatory submissions/documents.
  • Participates in publication planning
  • Participates and/or leads the development of internal and external presentations/publications (manuscripts, posters, etc.) of clinical study data
  • Clinical Data Review and Analysis
  • Works closely with biometrics and data team to plan analyses of clinical data
  • Performs ongoing clinical data review and critical analysis of study data, partnering with the SRP and data management
  • Provides clinical science-related contributions to developing case report forms (CRFs), CRF completion guidelines, and statistical analysis plans.

Candidate Requirements:

  • Advanced degree in life sciences and/or health-related field, with 10+ years of drug development experience or bachelor’s level education with equivalent working experience
  • Basic knowledge of autoimmune diseases and/ or medical oncology.
  • Strong understanding of Good Clinical Practice, the drug development process, and the design and conduct of clinical trials. Experience in conducting trials on autoimmune diseases will be a plus
  • 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
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.