- Create, review, and update clinical supply and demand plans, and as appropriate use simulation tools to drive optimal clinical supply efficiency
- Communicate and update clinical supply requirements on study and program levels to project teams as required
- Monitor inventory levels at depots and clinical sites through the life of a trial; recommend and coordinate preventative actions to avoid potential supply issues
- Review clinical trial protocols and understand impact on supply
- Ensure regular interaction with cross-functional team members related to changes in supply configuration, trial design, enrollment timeline, manufacturing availability and regulatory requirements are considered
- Assist with label management for clinical product which includes creation of master label text, translations, and label proofs
- Manages the packaging Batch Record review and approval process with Quality Assurance
- Works closely with Quality Assurance and CMC to resolve temperature excursion
- Coordinate shipping oversight of clinical product to both US and ex-US locations
- Manage drug returns process and site close-out activities. Prepare drug reconciliation reports and see the process through to completion of destruction
- Communicate with external service providers/ partners on project requirements.
- Author or updates internal SOPs as required.
Required Skills & Experience:
- Bachelors in Life Sciences required.
- Minimum 3-5 years in Clinical Supply Management or a related field.
- At least 1-year direct experience in clinical supplies environment.
- Proficient knowledge of Microsoft Excel, PowerPoint and Project software required.
- Good understanding of clinical study design, execution, and impact of study drug supply.
- Demonstrated knowledge of clinical trial process from study start up through trial completion.
- Familiarity with various clinical trial designs (randomized, OLE, continued access).
- Demonstrated experience in inventory management and forecasting drug supply.
- Experience with IRT systems and managing the forecasting and planning of drug supply needs.
- General knowledge of GMP.
- Excellent communication and influencing skills, strong collaboration skills.
- Strong attention to detail.
- Ability to multi-task and manage complexity.
We believe that innovation, the ability to successfully advance our ground-breaking science and having fun as a team are enhanced by being together, in person. As we emerge from the COVID-19 pandemic with a high rate of vaccination among our employees, we have begun a return to our physical work environments and resumed some business travel to engage with stakeholders when appropriate. We have established guidelines to allow for flexibility in work arrangements that balance individual’s needs and preferences with the needs of our business and our desire to foster a culture of collaboration and innovation. For some roles, the necessity of being physically present every day has and continues to be a priority to ensure continued progress with our important work for patients. We will continue to evaluate our practices as we move through this unique period.
Stoke operates sites in Bedford, MA, and Cambridge, MA. This position will be based in Bedford.
This position will require approximately 20% travel.
Benefits & Compensation:
At Stoke Therapeutics we are proud to offer comprehensive and competitive employee benefits, including medical, dental and vision insurance; life, long and short-term disability insurance; Paid Parental Leave; a 401K program with company match, unlimited vacation time, and an Employee Stock Purchase Program (ESPP).
Compensation is market competitive for the industry and directly commensurate with experience. All positions are bonus and stock eligible.