Associate Director, Clinical Supply Chain Management
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AI Summary
About Stoke:
Stoke Therapeutics (Nasdaq: STOK), is a biotechnology company dedicated to restoring protein expression by harnessing the body’s potential with RNA medicine. Using Stoke’s proprietary TANGO (Targeted Augmentation of Nuclear Gene Output) approach, Stoke is developing antisense oligonucleotides (ASOs) to selectively restore naturally-occurring protein levels. Stoke’s first medicine in development, zorevunersen, has demonstrated the potential for disease modification in patients with Dravet syndrome and is currently being evaluated in a Phase 3 study. Stoke’s initial focus are diseases of the central nervous system and the eye that are caused by a loss of ~50% of normal protein levels (haploinsufficiency). Proof of concept has been demonstrated in other organs, tissues, and systems, supporting broad potential for Stoke’s proprietary approach. Stoke is headquartered in Bedford, Massachusetts. For more information, visit https://www.stoketherapeutics.com/
Position Summary
The Stoke Therapeutics team is seeking an experienced and driven Associate Director, Clinical Supply Chain to lead the planning, forecasting, and execution of clinical supply strategies that ensure uninterrupted drug availability throughout global clinical trials. This individual partners cross-functionally with Clinical Operations, Quality, Regulatory, Manufacturing, and external vendors to manage demand forecasting, inventory, FG production, distribution, and IRT strategy while ensuring regulatory compliance. 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.
Key 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.
- Monitor inventory levels at depots and clinical sites through the life of a clinical trial.
- Ensure regular interaction with cross-functional team members related to changes in supply configuration, trial design, enrollment timeline, manufacturing availability, and regulatory requirements.
- Generate manufacturing requests, review pre-production and post-production documentation with Quality Assurance to coordinate the timely release of IMP.
- Coordinate import and export of materials to support clinical and non-clinical studies.
- Support the procurement, labeling, and distribution of ancillary supplies.
- Facilitate the development of pharmacy manuals and any related updates
- 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.
- Responsible for management, compliance, and oversight of relevant eTMF sections.
- Support the process for label generation and approvals, including regulatory variations and translation activities.
- Manage study closeouts and drug reconciliation at study end
- Work closely with Quality Assurance to resolve temperature excursions.
- Monitor shelf-life and expiry dating of IMP and coordinate retest extension to ensure continuous supply.
Required Skills & Experience:
- Bachelors in Life Sciences required, advanced degree preferred.
- 8+ years in Clinical Supply Management or a related field.
- Proven experience supporting clinical trial supply, with a strong 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) and Supply Chains role in supporting material demands.
- 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.
Location(s):
Stoke is located in Bedford, MA, and will be moving to a new location in Waltham, MA by the end of 2026. This position is eligible for either remote or hybrid work arrangements.
Travel:
This position will require approximately 10% travel.
Compensation & Benefits:
At Stoke Therapeutics, we are committed to offering a comprehensive, competitive and thoughtfully designed total rewards program.
The anticipated salary range for this role is $182,000 - $199,000. 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. In addition to base salary, Stoke offers an annual bonus and equity participation.
Our benefits package includes medical, dental and vision insurance; life, long- and short-term disability insurance; paid parental leave; a 401K plan with company match, unlimited vacation time, tuition assistance and participation in our Employee Stock Purchase Program (ESPP).
Culture & Values:
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.
Our values guide our work to deliver meaningful medicines for people who need them. 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.
Interested candidates: Please visit Stoke’s website to learn more and apply directly to the position listed on our Career Center:
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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