Stoke is seeking an enthusiastic, collaborative, and experienced DMPK specialist to join the Bioanalytical, DMPK and Biomarker Development group to support non-clinical and clinical DPMK activities. As a Principal Scientist/Associate Director in DMPK team, you will play a critical role in preparing and implementing strategies that will impact non-clinical and clinical development.
Key Responsibilities Include:
- Responsible for bioanalytical data and report review to ensure a high quality and timely delivery of data and study reports.
- Work with VP, DMPK in defining the technical parameters and milestones for outsourced clinical and nonclinical bioanalytical projects including method development, validation, and sample analysis.
- Provide operational support in collaboration with the clinical team, clinical sites and CROs (including, but not limited to, sample collection/processing procedures, sample shipping and handling instructions, sample reconciliation, etc.).
- Contribute to relevant module in regulatory submission documents as needed.
- Serve as the DMPK representative at research, program core team and operational team meetings.
- Identify and manage external CROs for the design and execution of in vitro/in vivo ADME, PK and bioanalytical studies.
- Provide scientific leadership and mentorship for less experienced scientists.
- Manage the successful implementation of validated bioanalytical methods at CROs in support of clinical studies.
- Participate in budgeting activities.
Required Skills & Experience:
- PhD with minimum 9 years of post-Ph.D. experience, including a minimum of 5 years industry experience in relevant field.
- Solid understanding of drug metabolism, bioanalysis, pharmacokinetics, preclinical pharmacology and clinical study designs.
- Experience in writing bioanalytical package to be included in regulatory submissions
- Industrial experience in the bioanalytical method development (LC-MS/MS, Ligand binding assays etc.) validation and sample analysis under GLP and GCP regulations.
- Strong knowledge in GLP regulations that pertain to Bioanalytical Development
- Experience in nucleic acids-based therapeutics and nonclinical toxicology is highly desired.
- Excellent communication and interpersonal skills, and proven success working in a matrix environment.
Approximately 5% of this position may require travel.
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.
Location(s): 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.