Vice President, Medical

Larimar Therapeutics•Philadelphia, PA

About The Position

The Vice President, Medical will serve as a key leader in shaping and executing all aspects of clinical development within the organization. This executive role is responsible for guiding and supporting clinical research activities, optimizing the safety of study participants and the integrity of clinical data, and representing the Medical leadership in all internal and external interactions. The individual in this role must be able to exercise superior intellectual prowess, judgement, creativity, and flexibility, moving fluidly from providing definitive leadership and direction to cross-functional collaboration with colleagues to performance of everyday tasks. This role will include participation as a member of the company’s management team and will require occasional domestic and international travel.

Requirements

Medical degree (M.D., 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

Nice To Haves

neurology or cardiology background preferred
Prior experience in neurology and/or rare disease preferred
Experience with activities related to Medical Affairs a plus but not required

Responsibilities

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