The Position

We are looking for a highly motivated individual to be part of the preclinical pharmacology and toxicology team reporting to the Vice President of Toxicology. This is a dynamic role participating in the advancement of preclinical research into the clinic, with particular focus on the execution of exploratory, pilot, and pivotal (GLP) toxicology studies. The Toxicologist will partner with the Vice President of Toxicology to develop and carry out the overall toxicology strategy for programs in both Discovery and Development. The Toxicologist will collaborate with external vendors, the internal preclinical pharmacology and toxicology team, and other stakeholders across the company to ensure efficient processes that scale with Verve's continued growth.

Job Responsibilities

• Engage in scientifically based, defensible but innovative and non-traditional study designs and approaches for advancing new modalities through clinical development including:
  • Developing DART strategies
  • Ensure appropriate toxicological animal models are employed in discovery/development programs
  • Drive in vitro toxicology assays to address investigative toxicology questions, as needed
• Internal:
  • Partner with internal teams to oversee, manage, track, and coordinate key study deliverables, study plans/protocols, data, and reports
  • Keep proper archiving of all study related materials
  • Assist in the planning of study-related meetings with internal study teams
  • Partner with Finance and Legal groups to execute POs, NDAs, MSAs, CDAs, SOWs
  • Using PRISM/Excel, organize data into tabular/graphic forms to inform key messages
• External:
  • Design and direct nonclinical safety studies, including the evaluation and interpretation of safety pharmacology, toxicology and toxicokinetic information
  • Review, interpret, and provide feedback on study protocols and reports
  • Partner with Contract Research Organizations (CROs) to track and coordinate key study deliverables (protocols/study plans, data, reports)
  • Schedule, create, distribute and review study-related documents
  • Track key study milestones using current project management tools
  • Lead implementation and management of study data through file management and document control; ensure proper archiving of all study related materials
  • Assist in the planning of study-related meetings
  • Execute the generation and distribution of POs
  • Conduct study monitoring at external vendor sites (10% travel)
  • Be a thought partner providing scientific input for in vivo preclinical toxicology studies
• Other duties as assigned

Qualifications

• PhD 5 years' experience in toxicology or other closely related life sciences field, in the industrial or CRO setting, executing, or managing in vivo studies for the purpose of advancing a biological therapeutic candidate into the clinic (BS 11 years or Masters 9 years will also be considered)
• Experience in gene editing or gene or cell therapy (desirable)
• Familiarity with ICH guidance(s) pertaining to Cell and Gene Therapies (desirable)
• Experience in developing toxicology programs to carry out early and later stage drug development (desirable)
• GLP experience
• Ability to oversee CRO interfaces to enable high quality studies and reports
• Strong interpersonal skills to build relationships with key stakeholders
• Ability to work effectively with cross-functional teams and deliver against goals within a matrixed environment
• Ability to unite program and business goals
• Ability to foster and contribute to a culture of excellence grounded in problem solving and teamwork
• Excellent communication skills including strong writing
• Ability to prioritize and to manage complexity
• Willingness to be creative and adaptable to assist a growing organization
• Experience with program management tools such as MS Project, Smartsheet, OnePager or similar
• Excellent organizational skills and strong attention to detail
• Microsoft Office, PRISM, Graph Pad experience