Graphite Bio is a clinical-stage, next-generation gene editing company harnessing high efficiency targeted gene integration to develop a new class of therapies to potentially cure a wide range of serious and life-threatening diseases. Graphite Bio is pioneering a precision gene editing approach that could enable a variety of applications to transform human health through its potential to achieve one of medicine’s most elusive goals: to precisely “find & replace” any gene in the genome. Graphite Bio’s platform allows it to precisely correct mutations, replace entire disease-causing genes with normal genes or insert new genes into predetermined, safe locations. The company was co-founded by academic pioneers in the fields of gene editing and gene therapy, including Maria Grazia Roncarolo, M.D., and Matthew Porteus, M.D., Ph.D.
Graphite Bio is seeking a highly motivated Clinical Scientist to be responsible for bringing together clinical, scientific, and technical disciplines to ensure high-quality protocol development, study execution, and data interpretation. Our Clinical Scientist is a key member of our clinical team and partners closely with other clinical team members, applying technical and scientific excellence to support the development and execution of clinical trials to meet the needs of internal and external customers. Our Clinical Scientist responsibilities impact key elements of the study lifecycle including protocol development, safety monitoring, data quality review, patient narratives, and preparation of Clinical Study Reports. This position will be based in our South San Francisco Office.
What You Will Do:
- Drives protocol and ICF development, content, and quality review with minimal guidance
- Assists in writing protocol synopsis, clinical sections of the protocol, and protocol amendments in collaboration with other clinical team members
- Contribute to the clinical investigation plan for INDs and Investigator Brochures
- Ensures study plans and related documentation are accurate and complete
- Partners with data management to develop data review plan.
- Reviews patient level, and cumulative data per the data review plan, and coordinates with others for study level review; escalates questions to Medical Monitor
- Reviews and adjudicates protocol deviations
- Answers specific site protocol questions as needed and may provide issue resolution if medically qualified
- Participates in protocol training for Site Initiation Visits and Investigator Meetings, including training of study vendors and CRO staff
- Identifies scientific quality issues to discuss with investigators and study sites so that corrective actions may be instituted
- Assists in the preparation of clinical content for regulatory submissions/documents
- Support and contribute to requests for information from health authorities
- Assists Clinical Operations in assuring adherence to Good Clinical Practice, investigator integrity, and compliance with all study procedures
- Participates in interpretation and presentation of study results, including authoring of Clinical Study Reports
- Support the preparation, review, and submission of clinical publications
- May support clinical development planning and study designs in collaboration with the Clinical Development Lead
- Other duties as assigned
What You Will Bring:
- Degree in Life Sciences or health-related field (MD, PharmD, PhD, MS, RN)
- 3+ years of drug development experience or equivalent clinical research experience at CRO or academic institution
- Cell or gene therapy experience is a plus
- Proficient at clinical data review including query generation and management
- Strong understanding of Good Clinical Practice
- Ability to work independently
- Strong knowledge of clinical research process, including working knowledge of all functional areas of clinical trials and medical terminology
- Experience in monitoring and/or coordinating clinical trials required
- Excellent written and verbal communication skills to express complex ideas to study personnel at research and clinical institutions.
- Ability to interact with all levels of staff to coordinate/execute study activities.
- Ability to handle several priorities within multiple, complex trials
- Ability to travel as needed
What Graphite Will Bring:
At Graphite Bio, we are intentionally building a community that is inspired, diverse, and curious. For this role, and all roles, we seek someone who is:
- Determined. You share our mission to bring curative gene editing to patients. And you know the need is urgent.
- People-focused. You prioritize relationships. You value differences and are an excellent listener.
- Adaptable. You seek solutions, even when things change. You prefer to find your way to “yes!”
Graphite Bio is an equal opportunity employer. We believe that our strength is in our differences. Our goal to build a diverse and inclusive team began on day one, and it will never end.
All company employees, regardless of work location, must be fully vaccinated for COVID-19. Fully vaccinated means a person has received all recommended doses in their primary series COVID-19 vaccine. Requests for an accommodation/exemption for medical or religious reasons, as well as under applicable state law, will be considered on a case-by-case basis consistent with applicable law.To all recruitment agencies: Graphite Bio does not accept agency resumes or applications. Please do not forward resumes to our jobs alias, or Graphite Bio employees. Graphite Bio is not responsible for any fees related to unsolicited resumes or applications.