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Stoke is seeking a highly motivated Research Associate to join a company pioneering genetic disease treatments. A successful candidate should have a strong interest and background in cellular and molecular biology research. This candidate will be a member of the In Vitro Pharmacology Group. Tasks will focus on evaluating oligonucleotides for therapeutic projects. The candidate will support implementing and executing biochemical or cellular biological assays. The candidate will be expected to perform the following activities:

• Evaluate oligonucleotide-based drug candidates in cell-based assays.
• Conduct in vitro disease model cellular assays to evaluate drug candidates.
• Perform cell and molecular biology techniques including RNA isolation, protein isolation, RT-PCR, qPCR, western blot, and other project-specific assays, as necessary.
• Troubleshoot experiments, analyze, interpret data, participate in development of new assays.
• Maintain accurate documentation of experiments in electronic lab notebook (ELN) and draft technical reports.
• Present research findings at group meetings and occasional company-wide and external meetings.
• Work independently as well as collaborate with peers in a result-oriented research environment.

Required Experience:

• B.S/M.S. with a minimum of 5 years post-graduate experience in molecular and cell biology research, preferably in industry, or M.S. with minimum of 2 years post-graduate experience in molecular and cell biology research, preferably in industry.
• Experienced in standard cell culture techniques.
• Experience in molecular biology, RNA isolation techniques, and cell-based assays are a must.
• A plus would be prior participation in phenotypic assays, iPSC disease model assays, or antisense-based target validation.
• Work experience in therapeutic areas involving CNS or ocular disease desirable.
• Strong organizational and recordkeeping skills, experience using ELN is highly desirable.

Travel:
Approximately 5% 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 is based in Bedford, MA. Stoke operates sites in Bedford, MA, and Cambridge, MA.

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This is an opportunity for a clinician at a fast-growing company focused on precision medicines for genetic diseases.  Join Stoke’s experienced and dedicated team to lead the development of transformative therapies for life threatening diseases. The Senior Medical Director will lead and drive strategy for the company’s global genetic epilepsy clinical development portfolio, including Dravet syndrome, taking into consideration medical, scientific, regulatory and commercial aspects. This position will also lead a multi-disciplinary, matrix team through highly complex decisions. This individual has the ultimate responsibility for development decisions assessing and integrating the input from various disciplines to create, maintain, and execute a global clinical development plan for each clinical program that will result in the regulatory approval of the compounds in multiple regions. This individual interacts with and influences senior leadership in decision-making for the projects by setting strategic direction.  This individual will have demonstrated a track record of success in his/her field, the capacity to lead with minimal supervision, plan strategically, achieve goals on time, and communicate effectively. This position also offers the opportunity to apply Stoke’s platform to other serious diseases (including other neurologic diseases and ophthalmic diseases) and will take on a major leadership role in a rapidly growing organization. This position reports to the Chief Medical Officer of the company.

Key Responsibilities Include:

Synopsis / Protocol Development, Study Execution, & Study Interpretation

• Lead and supervise a clinical team of at least one medical director, collaborating closely with the Clinical Operations team, and be accountable for all deliverables of clinical trials under his/her direct responsibility.
• Responsible for the clinical content of all clinical and regulatory documents, including protocols, INDs, CTAs, investigator brochures, CRF’s, CSRs and IND reports.
• Responsible for analysis of clinical data, including safety monitoring in collaboration with Safety team.
• Help ensure Clinical Study Team compliance with FDA, EMA, PMDA, ICH and GCP guidelines and internal SOPs.
• Hires, manages, mentors, motivates, empowers, develops, and retains staff to support assigned activities. Conducts performance reviews and drives goal setting and development planning.

Clinical Development team leadership

• Lead Global Development Team for Dravet Program.
• Establish and drive Development Team strategy and deliverables producing the Development Strategy and Clinical Development Plan. Provide continual critical evaluation of the development strategy to maintain a state-of-the-art development plan.
• Responsible for high impact global decisions: monitoring and interpreting data from ongoing internal and external studies, assessing the medical and scientific implications, and making recommendations that impact regional and global development such as go/no go decisions or modification of development plans or study designs that may have a significant impact on timelines or product labeling.
• Communicate program developments and clinical trial results to senior management and collaborate with senior management on key strategy and decision-making.

Portfolio development and Strategic Corporate planning

• Contribute in an active and ongoing manner to the scientific, clinical, and commercial development of current and future product candidates.
• Aid in developing the clinical strategy for our portfolio programs and work cross-functionally to evaluate, select, plan and execute R&D projects.

External Interactions

• Represent clinical development at FDA, CHMP, PMDA and other regulatory agencies.
• Develop and maintain relationships with key opinion leaders and Principal Investigators.
• Organize and present at relevant clinical advisory boards and medical meetings.
• Write manuscripts, publications, or other documents intended for external audiences.

Due Diligence, Business Development and Alliance Projects

• Participate in evaluation of potential business development opportunities, conduct due diligence evaluations, and development and negotiation of clinical development plans for potential alliances and or in-licensing opportunities.

Required Experience:

• MD or MD/PhD.
• Board certified or eligible in a medical or pediatric subspecialty preferred.
• Expertise in Neurology or Orphan diseases preferred.
• 8+ years of overall relevant experience within pharmaceutical/biotech industry or academic medicine.
• At least I2 years of early clinical development experience in an industry setting.
• Experience with oligonucleotide therapeutics is an advantage.
• Experience with design, execution, and analysis of Phase 1-2a clinical studies.
• Thorough understanding of Phase I-III drug development with proven ability to plan and conduct clinical trials, deliver high quality results within established timelines, interpret, analyze, and communicate clinical/scientific data.
• Excellent written and verbal communication skills to meet the needs of varied audiences.
• Strong interpersonal skills commensurate with the need to work closely with partners, investigators, contractors, consultants, and team members across functions.
• Knowledge of FDA/EMA requirements, good clinical practices, and pharmaceutical clinical development.
• Excellent analytical, problem-solving, and strategic planning skills.
• Well organized with strong management, leadership, mentoring and motivational skills.
• Ability to work independently and thrive in a fast-paced environment.
• Attention to detail, demand for high-quality work, and sense of passion and urgency to achieve goals and improve the lives of patients.

Travel:
Approximately 30% of this position will require travel (domestic and international).

Location(s):
This position will primarily be located in Cambridge, MA, and may also work occasionally from Bedford, 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.

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Stoke is seeking an enthusiastic and highly motivated Associate Director to join the Clinical Operations group. The successful candidate will be responsible for leading clinical trial(s) and a team to make key decisions related to the overall clinical trial execution strategy.

Key Responsibilities Include:

• Independently leads projects with focus on successful delivery of trials within time, quality, and budget expectations while adhering to strategy and performance against key metrics and corporate goals.
• Understands the broader industry and uses knowledge of competitive environment to drive efficiency and sense of urgency through trial(s) while maintaining high quality standards
• Sets the standard for trial management at Stoke by demonstrating a high level of knowledge of clinical operations’ methodologies, organizational, project management and leadership capabilities as well as increased strategic insight, decisiveness, and strong judgment
• Leads cross-functional Clinical Study Team meetings
• Makes certain that there is appropriate identification and ongoing assessment of risks and risk mitigation to ensure integrity of programs and to maintain trial progress
• Works closely with Clinical Development staff and peers to ensure that study plans are aligned and in support of broader goals and objectives and that there is consistency in approach to management of clinical trial programs
• Ensures that multiple, novel ideas on how to deliver on clinical trials are generated and considered
• Builds and implements resource planning and management skills, processes and standards while using an understanding and knowledge of different clinical phase requirements to ensure effective resource management across trials
• Oversees and manages CRO and multiple vendors including budgets and timelines
• Ensures outsourced resources, technology and procedures used by external partners, vendors or CROs align with resourcing needs within Clinical Operations
• Ensures the voice of the patient is represented in the planning, design and conduct of clinical trials
• Identifies opportunities and leads initiatives to streamline processes and enhance productivity, efficiency and quality of outputs for Clinical Operations

Required Experience:

• Minimum 5-7 years of industry experience.
• Bachelor’s Degree in a health related or scientific discipline is required.
• Minimum 4 years managing clinical studies.
• Proven track record in resource planning, forecasting, and budgeting.
• Expertise in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP.
• Rare Disease experience preferred but not required.
• Demonstrates extensive clinical trials experience.
• Demonstrates excellence in complex trial management, effective management of multiple projects/priorities, vendors and budgets.
• Demonstrates understanding of pharmaceutical regulatory requirements and strategic implications for clinical development operations.
• Demonstrates ability to lead multifunctional teams, mentor and coach junior staff.
• Excellent organizational, verbal, written and presentation skills.

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 be primarily located in Cambridge, MA, and may also work occasionally from Bedford, MA.

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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