Regional Medical Director – Southern US, Global Medical Affairs

About Stoke:

Stoke Therapeutics (Nasdaq: STOK), is a biotechnology company dedicated to addressing the underlying cause of severe diseases. The company is pursuing an entirely new approach to treating severe diseases. We are initially focused on diseases of the central nervous system and the eye, with an emphasis on haploinsufficiencies, which are diseases caused by a loss of about half of the normal protein levels. Rather than replace, repair or edit faulty genes, we aim to increase – or stoke – protein output from healthy genes to restore functional protein levels using our proprietary TANGO (Targeted Augmentation of Nuclear Gene Output) platform. In all, Stoke has identified ~6500 genes with a TANGO signature, representing broad potential for our approach to help people with severe diseases. 

We recently announced landmark data that support the potential for STK-001 to be the first disease-modifying medicine for Dravet syndrome, a severe and progressive genetic epilepsy that is characterized by frequent, prolonged and refractory seizures, beginning within the first year of life. The disease is classified as a developmental and epileptic encephalopathy due to the developmental delays and cognitive impairment associated with the disease.

Stoke is also advancing STK-002, a potential treatment for autosomal dominant optic atrophy (ADOA), the most common inherited optic nerve disorder. Currently there are no approved treatments for ADOA. Clinical studies of STK-002 are anticipated to start in 2024. The company is pursuing potential new medicines for three additional neurodevelopmental disorders, including Syngap1 and Rett syndrome, in collaboration with Acadia Pharmaceuticals. 

Position Purpose:

The Manager, Document Control will support the maintenance of Stoke’s electronic document management system to ensure compliance with US and international regulations, laws, and guidelines. This person will be accountable for maintaining Stoke’s Electronic Document Management System (Veeva Vault Quality) and related processes for document management and retention. This individual will contribute to maturing and shaping Stoke’s EDMS to meet the various phases of clinical development. In this role this candidate may be required to support GMP training, IT changes and computer systems validation, internal audits, and inspections. The candidate shall have a demonstrated ability to translate strategy into action with excellent analytical skills and an ability to communicate complex issues clearly to a broad group of people. This individual should have experience in orchestrating plans to resolve issues and mitigate risks in a timely manner. The candidate will influence Stoke’s culture of quality to help reach a sustained state of inspection readiness. This person will report to the Director of Quality Systems and will interface closely with other cross-functional groups such as CMC, Regulatory CMC, Regulatory Operations, Regulatory Development, Clinical Operations, Clinical Development, IT and other functions within Quality.

The ideal candidate will have a strong working knowledge of relevant FDA, EU, ICH GMP, guidelines, and GMP regulations and experience working in a virtual environment. It is preferred that this person have prior experience supporting regulatory inspections. A demonstrated ability to think outside of the box with a pragmatic risk-based approach for quality management is essential to this role. The candidate should be willing to directly contribute to the improvement of processes and resolution of issues as required.

Key Responsibilities:

• As the system owner, responsible for managing and administering Stokes EDMS.
• As the assigned QA document control representative, responsible for processing Stoke’s controlled documents.
• Responsible for maintaining compliance per Stoke document retention policies.
• Responsible for maintaining Stoke’s Document Control & Document Retention program including necessary procedures, records, manuals, and trend reports.
• Lead EDMS changes and process improvements to increase efficiency, effectiveness, continuous improvement, and maintain compliance with evolving GMP regulations and business needs.
• Collaborate with IT on system risk assessments for new system releases for Stoke’s EDMS and periodic system reviews.
• Contribute to Change Controls for configuration changes to support system enhancements for Stoke’s EDMS.
• Generate and monitor metrics, including tracking and trending document KPIs to identify gaps and propose corrective actions
• Represent quality on project teams, as needed and provide GMP compliance interpretation, consultation, and other supportive services necessary to maintain and improve compliance for document management and data integrity.
• Support GxP regulatory inspections and audits, as necessary and assist in training/preparing Stoke GxP employees for regulatory inspections.
• Support Stoke’s Quality / Regulatory intelligence process to ensure that regulations, standards, and industry best practices are implemented for document control, GxP computer system validation and lifecycle management, GDocP, data integrity, document retention and archival.
• Other duties as assigned.

Required Skills & Experience: 

• BS/BA, MS in life sciences or chemistry with a 5+ years of experience in document management.
• Strong working knowledge of relevant FDA, EU, ICH GMP regulations and guidelines with proficiency in interpreting requirements for computer system validation and maintaining an EDMS for GxP applications in a practical manner.
• Ability to identify areas of improvement and implement practical solutions as it relates to document management utilizing an EDMS.
• Experience supporting regulatory inspections (back-room document management).
• Possess a flexible approach to problem solving, be an adept negotiator and apply risk-based pragmatic decisions.
• Ability to work independently and collaboratively, as required, in a fast-paced start-up environment consisting of internal and external team members.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.

Location(s):

Stoke operates sites in Bedford, MA, and Cambridge, MA. This position is a hybrid position with an office setting based in our Bedford, MA location.

Travel:

This position may require approximately 5% travel.

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 Committee (DIB) underscores the importance of DIB to who we are and what we do. 

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.

Interested candidates: Please visit Stoke’s website to learn more and apply directly to the position listed on our Career Center:

For more information, visit https://www.stoketherapeutics.com/ or follow the company on Twitter at @StokeTx.

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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