Stoke is seeking an enthusiastic, motivated Sr Manager, Clinical Operations. The candidate will lead study operational strategy and planning and oversee execution of clinical studies for an assigned clinical trial(s), supporting clinical strategy defined in Clinical Development Plan. In close collaboration with Clinical Operations Program Lead(s), you will oversee the execution of studies in assigned clinical program(s) in compliance with quality standards (including ICH GCP, local regulations and Stoke SOPs), within approved timelines and budgets. This position will report into the Senior VP, Development Operations.
- Leads all aspects of assigned clinical trial(s) (Natural History, Phase 1-3) and demonstrates a high level of knowledge of clinical operations’ methodologies, organizational, project management and study team leadership capabilities.
- Actively participates in the development of department initiatives, including acting as lead on the development /definition of SOPs and processes.
- Utilizes project management skills to ensure consistency in processes and drive Clinical Operations performance.
- Responsible for the management and oversight of all study vendors (CRO) to ensure that Stoke’s clinical trials are getting the necessary resources and attention the vendor has committed to, ensures trial oversight plans are in place and updated as appropriate, ensures trial deliverables and performance goals are met and quality is maintained.
- Oversees the development of and adherence to clinical trial project timelines and ensures line function heads are informed of and understand risks / challenges, which includes putting risk mitigation plans in place, monitoring risk metrics, and communicating those risks.
- Provides input into clinical study protocols, informed consent forms (ICFs) and other clinical trial documents.
- Coordinates the relevant and timely exchange of information / materials (e.g., subject enrollment, site selection/feasibility, and data collection) with other Stoke functions to support clinical trials delivery within the drug development process.
- Coordinates with CMC regarding drug forecasting and supply of drug products to sites.
- Supports timely and efficient database lock by ensuring monitoring plans are in place and by participating in data review / reconciliation efforts.
- Adheres to clinical trial budgeting process and provides input to finance on budget accruals and forecasts.
- Participates in clinical trial scenario planning (estimates time and cost).
Required Skills & Experience:
- Bachelor’s degree or higher in a scientific or healthcare discipline preferred.
- Minimum of 6-8 years of progressive experience in clinical operations within biotech, pharmaceutical, CRO industry.
- Experience monitoring clinical studies and conducting and/or overseeing PSVs, SIVs, IMVs, and COVs are required.
- Rare Disease and Neurology trial experience are highly desirable.
- Proficiency in Microsoft Word, Excel, and Outlook, PowerPoint, and MS Project
- Strong written and verbal communication skills
Stoke operates sites in Bedford, MA, and Cambridge, 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.
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.