Sr. Corporate Counsel, Clinical Research And Development

Stoke Therapeutics, Inc. Cambridge , MA 02138

Posted 7 days ago

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 Sr. Corporate Counsel, Clinical Research and Development, will be a key business partner for Stoke's clinical operations and clinical development teams in connection with our current and upcoming clinical trials. In addition to providing legal review of relevant clinical documents and agreements, the ideal candidate will be responsible for providing strategic advice on legal topics arising from US and ex-US clinical development. This position will report to the General Counsel.

Key Responsibilities:

  • Be the primary legal contact for the clinical development and clinical operations teams for global legal issues related to clinical trials and development.

  • Provide legal support for a variety of clinical agreements, including Clinical Trial Agreements (CTAs), confidentiality agreements, collaborations, general services or licensing agreements, and sponsored research.

  • Manage data privacy and data protection related matters related to clinical trials, including reviewing ICFs, data processing agreements, privacy notices and compliance.

  • Offer legal and strategic guidance on clinical-related legal issues, including regulatory compliance, inspections, publications, and alignment with ethical standards and laws.

  • Proactively identify and address legal issues through relationships with clinical development and clinical operations teams.

Required Skills & Experience:

  • JD required, licensed and currently in good standing to practice law in one or more jurisdictions.

  • Minimum 10+ years or more of legal experience advising on pharmaceutical and biotechnology clinical trials.

  • Expertise in clinical agreements, data privacy and clinical compliance, with preference given for EU and UK experience.

  • Strategic mindset with demonstrated ability to develop trusted relationships with internal teams.

  • Ability to manage complex legal issues and advance business goals.

  • Strong communication and interpersonal skills.

  • Ability to work independently, collaboratively and proactively.

  • 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 and is based in the Cambridge location. Occasional travel to Bedford as needed based on client needs.

Travel:

This position will require minimal 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:

https://www.stoketherapeutics.com/careers/

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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Sr. Corporate Counsel, Clinical Research And Development

Stoke Therapeutics, Inc.