Stoke Therapeutics (Nasdaq: STOK), is a biotechnology company dedicated to addressing the underlying cause of severe diseases by upregulating protein expression with RNA-based medicines. Using the company’s proprietary TANGO (Targeted Augmentation of Nuclear Gene Output) approach, Stoke is developing antisense oligonucleotides (ASOs) to selectively restore protein levels. Stoke’s first compound, STK-001 is in clinical testing for the treatment of Dravet syndrome, a severe and progressive genetic epilepsy. Dravet syndrome is one of many diseases caused by haploinsufficiency, in which a loss of ~50% of normal protein levels leads to disease. Stoke is pursuing the development of STK-002 for the treatment of autosomal dominant optic atrophy (ADOA), the most common inherited optic nerve disorder. Stoke’s initial focus is haploinsufficiencies and diseases of the central nervous system and the eye, although proof of concept has been demonstrated in other organs, tissues, and systems, supporting the company’s belief in the broad potential for its proprietary approach. Stoke is headquartered in Bedford, Massachusetts with offices in Cambridge, Massachusetts.
The Senior Medical Director of 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 to the Vice President, Neurology Clinical Development.
Key Responsibilities Include:
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 the 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:
MD or MD/PhD.
Board-certified or eligible in a medical or pediatric specialty preferred.
Expertise in Neurology or Pediatric Neurology preferred.
Strong record of basic and/or translational research productivity.
At least 6 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.
Ability to work independently and collaboratively, as required, in a fast-paced start-up 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.
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 needs and preferences with the needs of our business and our desire to foster a culture of collaboration and innovation.
Culture & Values:
Our values guide our work to deliver meaningful medicines to 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.
To protect the health and well-being of our team, company policy requires that all employees and all new hires be fully vaccinated against COVID-19. By applying, you are confirming that, if hired, you can satisfy this express condition of employment. We will make reasonable accommodations available as may be required by applicable law. We will continue to evaluate our practices as we move forward.
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.
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:
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.