Stoke is seeking a highly motivated Toxicologist to join a company pioneering genetic disease treatments. The position is responsible for providing expertise and leadership in the toxicology functional area and in building the preclinical safety data package for clinical development.
- Provide leadership, technical oversight, and strategic guidance for all nonclinical safety studies conducted to support Stoke Therapeutics discovery and development programs to ensure delivery of a high-quality safety package for development.
- Lead the design and direct management for nonclinical safety studies, including the evaluation and interpretation of safety pharmacology, toxicology and toxicokinetic information.
- Manage the preparation and presentation of nonclinical safety data for project teams, regulatory agencies, and management.
- Develop optimal CRO network to support non-clinical safety studies and identify, manage external CROs to conduct appropriate studies.
- Manage toxicology goals, priorities, resource requirements, budget, and timelines.
- Collaborate with discovery, DMPK, Chemistry/CMC functions as well as with key Clinical and Regulatory stakeholders.
- Regularly assess the oligonucleotide drug development field and use best practice for safety studies.
- Represent Stoke Therapeutics toxicology with key external stakeholders and partners.
Required Skills & Experience:
- Ph.D. in Pharmacology, Toxicology, or a relevant discipline with at least ten years of post-graduate drug development experience.
- Some experience with oligonucleotides or messenger RNA is required.
- Strong experience working with CROs is necessary.
- Experience with drug development in the CNS and/or eye is a plus.
- Strong organizational and recordkeeping skills.
- Strong presentational skills to be able to communicate to both internal and external audiences.
- Ability to work as a team player in a dynamic environment.
- Familiarity with GLP regulations and ICH/FDA guidelines.
Approximately 5% travel to CRO sites to monitor studies is required.
Benefits & Compensation:
Stoke Therapeutics offers comprehensive and competitive employee benefits, including medical, dental and vision insurance; life, long and short-term disability insurance; Paid Primary Caregiver Leave; a 401K program with company match, and an Employee Stock Purchase Program (ESPP). Compensation will be highly competitive for the industry and directly commensurate with experience.
Stoke operates sites in Bedford, MA, and Cambridge, MA. This position is based in Bedford, MA.
Since March 2020, Stoke’s office-based employees have been working from home and we have modified our business practices (including but not limited to curtailing or modifying employee travel, moving to partial remote work, and cancelling physical participation in meetings, events and conferences). We are continually assessing the impact of COVID-19 on our business and keeping in mind the best interests of our employees, patients, and business partners. For the foreseeable future, we anticipate the individual in this role will work from home and participate in meetings and company events virtually. At some point, we anticipate this role will return to working at one of our physical locations.