Sr. Medical Director/Medical Director, Neurology

Senior Medical Director/ Medical Director, Neurology Clinical Development

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 Senior Medical Director/Medical Director, Neurology Clinical Development, will be a key contributor to the Neurology programs at Stoke. This individual will participate in clinical development activities for the Dravet Syndrome program and for future indications. This individual will monitor clinical studies, review, and interpret clinical trial data, and contribute to clinical study documents and communications. This position will report into the Vice President, Neurology Clinical Development.

Key Responsibilities:Develop clinical study protocols across Neurology indications. Contribute to the clinical content of clinical and regulatory documents for Neurology programs including INDs, CTAs, investigator brochures, CRFs, CSRs, NDAs, MAAs, and annual IND reports.Lead clinical trials in Neurology indications under supervision of the Vice President, Neurology Clinical Development, collaborating closely with the Clinical Operations team.Interact with senior management and serve as a standing member of project team meetings. Participate in analysis of clinical data, including safety monitoring in collaboration with Pharmacovigilance.Develop and maintain relationships with key opinion leaders and Principal Investigators.Organize and lead relevant clinical advisory boards.Draft and/or Review manuscripts, publications, or other documents intended for external audiences.Help to ensure Clinical Study Team compliance with FDA, EMA, PMDA, ICH and GCP guidelines and internal SOPs. Required Skills & Experience: M.D. or M.D./PhD.Board certified or eligble in a medical or pediatric specialty preferred.Expertise in Neurology or Pediatric Neurology preferred.Strong record of basic and/or translational research productivity.At least5 years of experience in an industry setting. Substantial experience working on industry-sponsored trials will be considered.Knowledge of FDA/EMA requirements, good clinical practice, and pharmaceutical clinical development.Experience with oligonucleotide therapeutics is an advantage.Experience leading global phase 3 studies is desirable.Ability to work independently and collaboratively, as required, in a fast-paced environment consisting of internal and external team members.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.Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.Attention to detail, demand for high-quality work, and sense of passion and urgency to achieve goals and improve the lives of patients.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.

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

Travel:This position will require approximately 10% travel.

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.