Medical Director

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:

We are recruiting a Medical Director, to join our growing clinical development organization. The ideal candidate is a strong clinical scientist who will help contribute to our clinical development strategy and its execution. In collaboration with clinical and project teams, the successful candidate will plan, design, and execute clinical development research studies to evaluate the efficacy, safety, clinical pharmacology, and pharmacodynamics of GPH101 and other therapies.

What You Will Do:

• Function as a medical expert on Graphite Bio’s clinical development programs
• Design and execute clinical trials, including the development of clinical protocols and amendments, investigator brochures, annual reports, abstracts, manuscripts, and clinical study reports in collaboration with the clinical development team
• Serve as a medical monitor, including evaluation and ongoing review of the safety, pharmacology, and efficacy in ongoing and studies in close collaboration with the safety and clinical operations teams
• Provide consulting for clinical perspective for various internal functions
• Interface and lead interactions with investigators, academicians, and thought leaders via a variety of interaction settings including academic society meetings, advisory boards, and investigator meetings
• As the medical lead of a study, responsible for ensuring data quality, summary, and writing of clinical study report. Participate as a member in teams relevant to the assigned project (e.g., study execution team) in close collaboration with the clinical operations, biometrics, and oversight of the CRO
• Work on regulatory submission documents
• Establish and implement exploratory pharmacodynamic, and translational biomarker plans in conjunction with pre-clinical scientists, consultants, and collaborators
• Attend scientific meetings pertinent to clinical science activities
• Maintain clinical and scientific awareness in the area of expertise
  
  

What You Will Bring:

• M.D. with relevant medical training in hematology or oncology required; PhD is a plus
• Two years of industry experience ideally in pharma or biotech, designing, leading, and managing clinical studies preferred, includes involvement with clinical development planning; clinical trials design, execution, and analysis; and regulatory filings
• Understanding of the drug development process evidenced by the ability to execute and deploy drug development strategic plans, to develop contingency plans, to provide technical and strategic advice, to prioritize multiple tasks and goals and to meet milestones
• Knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines; familiarity with other international regulatory requirements is a plus.
• Ability to effectively evaluate outside expert advice
• Ability to communicate and provide clinical context to clinical, regulatory, biomarker, biostatistics, data management and manufacturing colleagues who may not have a medical background
• Ability to represent the program and engage external business partners /academics /regulatory bodies
• Ability to work independently as well as work effectively leading and participating in teams
• A strong sense of urgency; ability to proactively identify challenges and problems and propose solutions
• Excellent communications skills
• Ability to present clearly using scientific and clinical terminology
• Skilled at motivating team members within and collaborators externally; fosters and nurtures teamwork
• Willingness to travel (when safe post COVID)
• Flexibility to be onsite- in office, as needed to effectively support the development team

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.