Clinical Trial Manager

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.

Learn more about Graphite Bio by visiting www.graphitebio.com and following the company on LinkedIn.

The Role:

As a Clinical Trial Manager, you will play an integral role at Graphite both within the Clinical team as well as the wider organization. You will apply your existing operational and leadership skills, and play a key role in clinical trial planning and execution and help grow the company and guide its direction.

This role requires an individual who will be responsible for the operational management, including documentation and reporting requirements of a clinical development program. They will work directly with internal and external collaborators to ensure successful implementation of clinical activities/project deliverables within the required time frame and budget.

What You Will Do:

• Support the Study Lead in clinical trial execution
• Support investigator recruitment and selection, study start-up, enrollment, data collection, drug projections, and reports
• Vendor management including CROs, IRT, central labs, imaging, COAs
• Leading creation of study plans and manuals, coordinating study reports, sections for Investigator's Brochures, and Regulatory documents (e.g., IND, NDA or BLA)
• Planning resources and tasks to meet program objectives for timely initiation and completion of clinical studies
• Develop and review SOPs and guidelines in compliance with global regulatory guidelines and requirements
• Establish systems for tracking of various activities during clinical trials, e.g., tracking metrics, reviewing monitoring reports, data reviews and query resolution, etc.

What You Will Bring:

• Bachelor’s degree (or higher) in science or health-related discipline
• 5+ years of relevant clinical development experience in a sponsor (Pharmaceutical or Biotech) or CRO role and at least 2+ years in a clinical study management role; experience in cell or gene therapy highly preferred
• Demonstrated experience in the development, implementation, management, and completion of more than one major clinical trial
• Ability to assist in preparation of a clinical development plan, clinical trial design, protocol writing, and essential documents
• Strong understanding of GCPs, ICH, and knowledge of regulatory requirements
• Excellent written and verbal communication skills demonstrated by an ability to present clear instruction/direction to teams at the same level in the organization and influence at higher levels in the organization
• Ability to lead cross-functional teams as necessary to problem-solve arising issues
• Ability and willingness to travel 10%-15% of the time

 

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!”

EEO Statement

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. 

COVID-19 Policy

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.