Inozyme Pharma is seeking a Medical Director to join our growing team. We are looking for someone who will report directly to our Chief Medical Officer, and who will oversee medical aspects of our programs and become an integral part of the team for the development of enzyme replacement therapies for rare diseases.
We are seeking a talented, independent, and motivated clinician with an interest in clinical research to help design, implement, and drive global clinical development for the company’s product candidate, which has the potential to drastically improve the lives of patients with ultra-rare, life-threatening, and devastating genetic disorders. This role is a unique and exciting opportunity to join a company at a key inflection point in its history. The selected candidate will be at the forefront of changing the standard of care and improving the treatment paradigm for patients with significant unmet needs
Essential Duties and Responsibilities:
- Aid in developing the clinical strategy and integrated development plan for our programs and future programs in rare diseases, lead the execution of clinical trials, and work cross-functionally to implement, manage, interpret, and communicate the results of clinical trials
- Be responsible for the medical content of assigned clinical and regulatory documents, including clinical protocols, INDs, CTAs, investigator brochures, CRFs and development safety update reports
- Active lead in the development of study protocols, investigator brochures, clinical development plans and other key study documents in conjunction with other line functions
- Lead and supervise assigned clinical trials, collaborating closely with the Clinical Operations team, and with accountability for all deliverables of clinical trials under his/her direct responsibility
- Responsible for analysis of clinical data, including safety monitoring in collaboration with pharmacovigilance
- Develop and maintain relationships with key opinion leaders and PIs
- Organize and present at relevant clinical advisory boards, data monitoring committees and medical/scientific meetings
- Help ensure clinical study team compliance with FDA, EMEA, ICH and GCP guidelines and regulations, and internal SOPs
- Maintain a high level of clinical and scientific expertise in assigned disease area(s) by reviewing the literature, attending medical/scientific meetings, and through personal interchanges with consultants, thought leaders, investigators and internal stakeholders
- Support Medical Affairs to help identify and effectively interact with thought leaders to engage in scientific and medical exchange as well as understand unmet medical needs and data gaps
- Effectively interact with the company’s Board and management team to communicate and develop strategy
- Able to back up the Chief Medical Officer and serve as medical spokesperson for the company to external stakeholders including analysts and investors when necessary
- Travel, as needed, nationally and internationally
Desired Skills & Experience:
- MD, DO, or equivalent with completed residency and board certification in pediatrics and experience in rare diseases
- Fellowship training in cardiology, neurology, or endocrinology is a plus.
- At least two years clinical research experience in an industry setting, with experience in analysis of research data; working knowledge of biostatistics and pharmacokinetics; working knowledge of GCP, scientific and clinical research methods and clinical study design; and regulatory requirements for clinical studies
- Pharmaceutical/biotech industry experience, including time managing clinical trials and/or clinical development program(s)
- Excellent oral and written communication skills
- Ability to work collaboratively in a fast-paced, team-based matrix environment and to function independently as appropriate
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