Clinical DMPK Study Manager

Stoke is seeking an enthusiastic, motivated Scientist to join Drug Metabolism and Pharmacokinetics (DMPK) team. Drug Metabolism and Pharmacokinetics (DMPK) is a scientific discipline that assists discovery teams in selecting optimal drug candidates to enter clinical trials.  In addition, this team helps in evaluation of safety and adequate potency of the drug during discovery and development. The candidate will be a liaison between DMPK and clinical operations team. This position will report into the VP, DMPK.

Key Responsibilities:

  • Collaborate with DMPK scientists and clinical operations team to lead DMPK operations aspects of assigned clinical trial(s) (Phase 1-3).
  • Participate in clinical study team meetings and provide updates on vendor and study operations.
  • Coordinate the relevant and timely exchange of DMPK related information with clinical team to support clinical trials.
  • Coordinate all set-up, planning and maintenance of project with CRO Project manager to operationalize supplies to the sites and troubleshooting with study sites.
  • Responsible for preparing documents for sample collection and sample processing for bioanalytical and biomarker testing.
  • Responsible for tracking the samples e.g. shipment delays, temperature excursions and deviations.
  • Establish relationship with central lab and manage the timelines and budgets for central labs and bioanalytical lab vendors.
  • Participate in vendor calls and communicate with study vendors (CRO) to ensure that Stoke’s clinical trials are getting the necessary resources and attention the vendor has committed to.
  • Contributes to trial oversight plans.
  • Oversee the development of lab manuals, adherence to clinical trial project timelines and ensures line function heads are kept informed.
  • Provide input into clinical study protocols, informed consent forms (ICFs) and other clinical trial documents.
  • Participating in data review / reconciliation efforts.

Required Skills & Experience:

  • BSc., MSc. Or PhD. in a scientific or healthcare discipline.
  • Minimum of 2+ years of progressive experience working within drug development and/or clinical trial operational teams.
  • Technical experience, attention to detail and good organizational skills to support bioanalytical sections of clinical studies.
  • Experience working with contract research organizations and central laboratories.
  • Experience with project management and timeline management.
  • Knowledge of GLP/GCP Bioanalysis is desired.
  • Rare Disease and Neurology trial experience is desirable.
  • Proficiency in Microsoft Word, Excel, and Outlook, PowerPoint, and MS Project
  • Strong written and verbal communication skills

Location(s):

Stoke operates sites in Bedford, MA, and Cambridge, MA. This position is based in Bedford, MA.

Travel:

This position will require 10-15% 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.

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