Philadelphia, PA2 days ago
D.O.) required; neurology or cardiology background preferred; 10+ years of pharmaceutical industry experience with demonstrated progressive increase in management responsibilities; Prior experience in neurology and/or rare disease preferred; Experience with activities related to Medical Affairs a plus but not required; Track record of meaningful and substantial support of Phase 2 and Phase 3 studies, such as medical monitoring activities (data, coding, and protocol deviation review), contribution to and review of documents (protocols, informed consent forms, clinical study reports), and interactions with relevant external stakeholders (key opinion leaders, investigators, data monitoring committee); Proven excellent writing, presentation, communication, leadership, organization, and problem-solving skills; Established understanding of good clinical practices (GCP) and best practices related to evidence generation and scientific communications; Demonstrated appreciation of the needs and culture of a small company environment; Robust knowledge of clinical development, regulatory requirements, and healthcare compliance. Specific responsibilities include:
- Lead the medical guidance and support of clinical development programs, ensuring prompt, facilitative, and high value collaboration with Clinical Operations and the cross-functional study teams;
- In coordination with Statistics and Quantitative Sciences, review data and assist with interpretation of data from clinical studies;
- Partner with Safety and Pharmacovigilance to ensure provision of medical input as needed;
- Support Medical Affairs activities;
- Review and approve documents related to the clinical development program;
- Represent Medical at internal meetings and provide definitive guidance and direction;
- Supervise direct reports and external contractors;
- Ensure compliance with relevant regulatory law and guidance;
- Present medical and scientific information at study site visits and congresses;
- Represent Larimar Medical in engaging with external partners, regulatory bodies, and other external stakeholders;
- Perform other duties as appropriate at the direction of the Chief Medical Officer.