Stoke Therapeutics
Associate Director, Clinical Supply Chain Management
Bedford, Massachusetts, United States · Director
Sponsorship not specified$182k-$199kDetected 6 days ago
ForecastingExcelSupply ChainLogisticsProcurementInventory ManagementGMPExperimental DesignCommunicationCollaborationProblem SolvingMicrosoft OfficeDemand Planning
About the role
- The role plays a critical part in managing clinical supply activities from study startup through closeout, including labeling, logistics, ancillary supplies, temperature excursions, and shelf-life management.
- The ideal candidate possesses strong expertise in clinical supply management, forecasting, inventory planning, IRT systems, and cross-functional collaboration, with excellent communication, organizational, and problem-solving skills.
- This position will report to the Director of Supply Chain.
Responsibilities
- Partner with Clinical Operations to identify demand assumptions, such as enrollment rate, number of sites, number of countries, and internal milestone timelines to develop forecasts and associated supply/distribution plans based on clinical study protocols.
- Ensure regular interaction with cross-functional team members related to changes in supply configuration, trial design, enrollment timeline, manufacturing availability, and regulatory requirements.
- Coordinate import and export of materials to support clinical and non-clinical studies.
- Support the procurement, labeling, and distribution of ancillary supplies.
- Work with the clinical team to configure and set up Interactive Response Technology (IRT) Systems including automated randomization and drug supply management, including specification design, implementation, and user acceptance testing (UAT) for IRT systems, ensuring effective tracking, randomization, and inventory management.
- Support the process for label generation and approvals, including regulatory variations and translation activities.
- Manage study closeouts and drug reconciliation at study end
- Familiarity with various clinical trial designs (randomized, OLE, continued access) and Supply Chains role in supporting material demands.
- Our values guide our work to deliver meaningful medicines for people who need them.
Requirements
- Proven experience supporting clinical trial supply, with a strong understanding of clinical study design, execution, and impact of study drug supply.
- Required Skills & Experience:
Skills
- Bachelors in Life Sciences required, advanced degree preferred.
- 8+ years in Clinical Supply Management or a related field.
- Demonstrated knowledge of clinical trial process from study start up through trial completion.
- Demonstrated experience in inventory management and forecasting drug supply.
- Experience with IRT systems and managing the forecasting and planning of drug supply needs.
- Strong understanding of GMP and GDP.
- Proficient knowledge of Microsoft Excel, PowerPoint and Project software required.
- Excellent communication and influencing skills, strong collaboration skills.
- Strong attention to detail.
- Ability to multi-task and manage complexity.
- STOK), is a biotechnology company dedicated to restoring protein expression by harnessing the body's potential with RNA medicine.
Compensation
- The anticipated salary range for this role is $182,000 - $199,000.
- In addition to base salary, Stoke offers an annual bonus and equity participation.
Benefits
- At Stoke Therapeutics, we are committed to offering a comprehensive, competitive and thoughtfully designed total rewards program.
- In addition to base salary, Stoke offers an annual bonus and equity participation.
- The final offer will be determined based on a variety of factors, including role scope, experience and qualifications, education, market benchmarks, internal equity, and geographic location.
Company info
- At Stoke, 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, at least periodically.
- We 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.
- We are committed to being true to ourselves, to our colleagues, and to the people with severe diseases who are counting on us.
- We embrace diversity within a unique culture that is defined by our values.
- Our employee-led Diversity, Inclusion, and Belonging (DIB) Committee underscores the importance of DIB to who we are and what we do.
Equal opportunity
- https://www.stoketherapeutics.com/careers/
- For more information, visit https://www.stoketherapeutics.com/.
- All applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, physical or mental disability or protected veteran status.
- Stoke participates in E-Verify.
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