This is an opportunity for a clinician to join 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. We are seeking a talented, independent, and motivated clinician to help design, implement and communicate clinical trials for our Ocular Disease programs. This position reports to the Chief Medical Officer.
Key Responsibilities Include:
- Lead clinical development activities for Stoke’s Autosomal Dominant Optic Atrophy program under supervision of the Chief Medical Officer. Establish and implement the Clinical Development Plan for the program.
- Collaborate closely with the Clinical Development Operations team and be accountable for all deliverables of clinical trials under his/her direct responsibility.
- Contribute to the clinical content of all clinical and regulatory documents for the Autosomal Dominant Optic Atrophy program, including study design, writing protocols, INDs, CTAs, investigator brochures, CRF’s, CSRs, annual IND reports, and clinical expert reports.
- Represents the clinical function at health authority interactions
- Contributes to disease area strategy planning to influence the future portfolio
- Participate in analysis of clinical data, including safety monitoring in collaboration with Pharmacovigilance.
- Develop and maintain relationships with key global opinion leaders and Principal Investigators.
- Organize and present at relevant clinical advisory boards and SMCs.
- Author manuscripts, publications, or other documents intended for external audiences.
- Help ensure Clinical Study Team compliance with FDA, EMA, PMDA, ICH and GCP guidelines and internal SOPs.
- M.D. or M.D./Ph.D.
- Board certified or eligible in a medical or pediatric subspecialty preferred.
- Expertise in Ophthalmology is required.
- Strong record of basic and/or translational research productivity.
- At least 2 years of experience in clinical research in an industry setting.
- Experience with orphan diseases or oligonucleotide therapeutics is an advantage.
- 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.
- 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.
This position will require approximately 25% travel, both domestic and international.
This position will be primarily located in Cambridge, MA, and may also work occasionally from Bedford, MA.
Since March 2020, Stoke’s office-based employees have been working from home and we have modified our business practices (including but not limited to curtailing or modifying employee travel, moving to partial remote work, and cancelling physical participation in meetings, events and conferences). We are continually assessing the impact of COVID-19 on our business and keeping in mind the best interests of our employees, patients, and business partners. For the foreseeable future, we anticipate the individual in this role will work from home and participate in meetings and company events virtually. At some point, we anticipate this role will return to working at one of our physical locations.
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.