Join Our Team
At Stoke, we are building a team of talented scientists, experienced drug developers and insightful leaders to address severe genetic diseases.
We are excited about breaking new scientific ground. This work is challenging, but we know we have the team to do it. We’re united around a common goal: to improve the lives of people living with severe genetic diseases.
Current openings
Stoke is always looking for individuals with a passion for developing precision medicines to tackle severe genetic diseases.
Vice President, Chemical Development and CMC
This position will oversee all chemical development & CMC activities from IND to commercialization. This position is responsible for creating and executing a chemical development strategy to support all drug development activities, including the identification of key areas for investment, building appropriate internal and external capabilities, and communicating the company’s chemical development strategy both internally and to the external scientific community.
Key Responsibilities Include:
Specific duties and responsibilities include, but are not limited to:
- Create and execute overall development chemistry plan to ensure robust, cost-effective support of company drug development programs
- Oversee drug substance and drug product GMP manufacture and distribution
- Evaluate, select & audit CROs and CMOs to support drug development activities
- Oversee both internal chemical development team and external CROs and CMOs
- Oversee CMC activities for all programs
- Serve as SME author of CMC sections of regulatory submissions
- Regularly assess developments in the manufacture, formulation & delivery of oligonucleotide therapeutics and identify areas for future investment
- Communicate chemical development & CMC strategy and activities to senior management and Board of Directors on regular basis
- Serve as primary liaison with corporate partners on all issues related to chemical development & CMC
- Present updates of Stoke development chemistry at key scientific conferences
- Willingness to live and work in Boston area
- Travel for oversight of external CROs and CMOs is expected
Required Experience:
- A Ph.D. in organic chemistry or analytical chemistry or related discipline
- At least 15 years of industry experience, including at least 10 years in oligonucleotide therapeutics
- Extensive experience developing novel technologies, implementing technology transfer, and development of drug substance and drug product from early clinical phases through product registration
- Deep experience in the GMP manufacture, formulation and distribution of oligonucleotide therapeutics
- Prior experience in commercial supply of oligonucleotide therapeutics is a plus
- Proven ability as SME author of CMC sections of regulatory submissions for oligonucleotide therapeutics
- Positive experience managing multiple direct reports
- Strong presentation skills to facilitate communication with both internal and external audiences
- Strong decision-making skills to facilitate execution of timelines
- Ability to work as a team player
Travel:
Approximately 15% of this position will require 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.
Location(s):
This position will primarily be located in Bedford, Mass., and will also work occasionally from Cambridge, Mass.
Apply Here
Office Assistant/Site Services Associate
Stoke is seeking an enthusiastic and highly motivated Site Services Associate to join the Facilities and Engineering Department. This is an opportunity to learn what it takes to support a busy biotechnology research lab from the standpoint of lab materials, including inventory management, purchasing and receiving.
Key Responsibilities Include:
- Provide reception support. Greet visitors, vendors and delivery personnel and direct them accordingly.
- Answer phone calls coming into the company’s main line. Triage callers as needed.
- Manage purchasing process of all lab consumables.
- May assist with new hire onboarding including ordering business cards, desk setup, badges, etc.
- Sort and distribute mail and packages.
- Manage scheduling of conference rooms.
- Assume responsibility for the maintenance of office equipment, including computers, copy machines and fax machines.
- Maintain office supplies and other inventories.
- Additional projects as assigned.
Required Experience:
- High school diploma required.
- 3+ years experience in an administrative role.
- Strong technical skills in MS Office required. Must be proficient in MS Excel.
- Demonstrated capability using financial concepts.
- Strong planning skills and follow through, strong interpersonal skills.
- Detail oriented and comfortable working in a fast-paced environment.
- Exceptional communication skills a must.
- Superior organizational skills and dedication to completing projects in a timely manner.
- Ability to maintain confidentiality.
Location(s):
This position will be primarily located in Bedford, MA and will also work occasionally from Cambridge, MA.
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.
APPLY HERE
Director/Senior Director Quality Assurance
Stoke is seeking an enthusiastic and highly motivated Director/Senior Director, Quality Assurance to join the Quality group. The successful candidate will be responsible for: helping to define, communicate and implement the company’s quality strategy and vision. This role will develop strong relationships, collaborate, and interact with various departments and levels of management at Stoke Therapeutics to accomplish the company’s objectives. This individual will also collaborate and develop strong relationships and partner with external collaborators to ensure the appropriate processes, systems, and activities are in place to protect the rights, safety, and welfare of study subjects.
Key Responsibilities Include:
- Provide strategic and proactive QA leadership in alignment with Global Head of Regulatory Affairs & QA
- Responsible for the operational management of local Quality Management System (QMS) covering GCP and/or GMP activities of a biotech company in alignment with corporate QMS.
- Manage and oversee the local QMS e.g.
- SOP system
- Training system
- Audit system covering GCP & GMP audits
- Batch disposition, recall, and field alert system
- Risk Management system
- Provide guidance, interpretation, support, training, and key input to relevant stakeholders in the company for consultation and interpretation of regulations, guidelines, corporate standards, and SOPs
- Development of employees (as the role grows)
- Provide input to budget planning and oversee budget for your area of responsibility
- Ensure inspection readiness
Required Experience:
- Bachelor’s Degree or above in a Science/Engineering or related field.
- 10 year’s experience preferred in the pharmaceutical/biotech industry and in QA, including direct experience in a GxP environment
- At least 5 years of demonstrated leadership experience in leading QA professionals
- Experience in performing audits of GMP and/or GCP areas highly desirable
- Experience in setting up quality system in GMP and/or GCP area
- Detailed knowledge of cGMP and GCP regulations (such as 21CFR part 210, 211, 312, 314 etc.) and guidelines (e.g. ICH GCP)
- Independent self-starter is a must
Travel:
Approximately 10-20% of this position will require 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.
Location(s):
This position will primarily be located in Bedford, Mass or Cambridge, Mass.
APPLY HERE
Sr Director, Head of Intellectual Property
Stoke Therapeutics is seeking a Senior Director/Head of Intellectual Property to help build and manage Stoke’s internal patent preparation and prosecution capabilities to support the development of life-changing therapies using Stoke’s proprietary TANGO technology. In addition, this individual will have responsibility for managing intellectual property matters critical to Stoke’s success, counseling senior Stoke business leaders, managing IP disputes, patent portfolio strategy and management, outside counsel budgets and performance, IP competitive intelligence, and due diligence in support of business development transactions. The successful candidate will have significant depth of experience in diverse aspects of patent law practice, high technical competency in the life sciences, and will be adept at serving as a trusted business advisor. This position is based in Bedford or Cambridge, Massachusetts and will report directly to the Senior Vice President, Chief Legal Officer.
Primary Responsibilities:
- Lead the growth and management of Stoke’s internal patent preparation and prosecution capabilities, including developing procedures and best practices.
- Develop strategies to develop and protect Stoke’s intellectual property assets (including its portfolio of in-licensed foundational IP for TANGO, as well as new IP directed to therapeutic applications of TANGO, development candidates, research findings and other related subject matter).
- Analyze relevant third-party IP and advise on potential pathways for managing against risks.
- Implement and lead IP strategy for R&D project teams and establish positive working relationships with the R&D project teams by acting as their advisor on a variety of IP related issues.
- Oversee outside counsel in prosecuting worldwide patent applications, conduct patentability and freedom to operate assessments, and manage IP disputes.
- Lead IP due diligence, IP review and IP agreement negotiation support for Stoke’s business development activities working collaboratively with Business Development, CMC & Manufacturing, and external counsel.
- Develop and continually expand a thorough understanding of Stoke’s current and planned business activities, programs, competitors, and markets and keep abreast of developing legal trends, laws and regulations.
- Provide patentability and FTO opinions in support of R&D project teams and Business Development transactions.
- Assist in the negotiation and drafting of collaboration, licensing and other agreements.
- Educate and advise colleagues on global intellectual property issues.
Required Skills and Qualifications:
- JD or equivalent, registered patent attorney, and at least 10+ years post-law school experience.
- Ph.D. or scientific degree in a relevant biological science (e.g., Biochemistry, Molecular Biology).
- IP practice experience in both a law firm and a bio/pharmaceutical corporate setting.
- IP experience with antisense, oligonucleotides, gene therapies and/or DNA/RNA-based therapeutics a plus.
- Ability to work collaboratively with other Legal department members and with the R&D organization, and successfully manage outside counsel.
- Must have excellent interpersonal, decision making and communication skills.
- Must have ability to manage multiple competing demands and prioritize effectively.
- Must have exceptional intellectual capacity and agility; business counseling gravitas; and demonstrated capabilities in establishing business practices to manage legal and other risks.
Compensation: Compensation will be highly competitive for the industry and commensurate with experience.
Locations: Cambridge, MA / Bedford, MA