Medical Director, Clinical Development (Remote)

Glycomine is a small clinical stage bio tech company committed to developing therapeutics for congenital disorders of glycosylation (CDG), serious rare diseases for which the vast majority of which do not have any disease-modifying treatment options available. Many of these diseases are driven by a genetic mutation that disrupts the function of an important enzyme. Glycomine’s lead clinical program in PMM2-CDG aims to deliver a substrate to bypass the enzymatic problem. 

Our team has a special dedication to find solutions to the significant unmet medical need experienced by patients and families with rare diseases. We come from many disciplines and bring multiple viewpoints and broad expertise to our mission. We are driven by the imperative and the opportunity to develop therapies that can provide meaningful improvements in the quality of life for patients, caregivers, and families.

Overview:

The Medical Director will play a key role on cross-functional teams responsible for the design, implementation, monitoring, analysis, and reporting of studies conducted for the clinical development programs. The successful candidate will have direct medical responsibility for creating clinical development plans, designing clinical studies, writing protocols, providing CRO oversight and safety monitoring of clinical programs. The Medical Director will contribute collaboratively toward the clinical aspects of research and early-stage development programs, providing insight into treatment indications, patient populations, study designs and overall development strategies.

The Medical Director, Clinical Development will report to Chief Medical Officer and is responsible for supporting clinical development, functioning as the medical lead and medical monitor for clinical trials, and working with cross-functional multidisciplinary study teams on clinical trial strategy, design, and execution. The ideal candidate will have experience as a medical monitor in early- to late-stage clinical trials.

Ideal candidate would be based remote in eastern time zone.

Responsibilities:

• Contribute to the development and execution of comprehensive clinical development plans for Glycomines’s development programs. Offer expert clinical advice, drawing on extensive clinical knowledge. Will review clinical study data and prepare reports, protocols, and development plans. Collaborate with early development research teams on clinical aspects and disease indications
• Serve as a medical expert in the company, staying current with the latest research and medical advancements in the fields being studied
• Contribute to the design and oversight of clinical trials, develop study protocols, case report forms, and informed consent documents, ensuring they are conducted in compliance with regulatory standards and ethical guidelines
• Collaborate with the regulatory team to prepare and submit regulatory documents to health authorities, including INDs, NDAs, and BLAs. Collaborate with study team to prepare and complete clinical study reports, investigator’s brochures and Data Safety Update Reports.
• Contribute to the Board meeting preparation including the Board of Directors, Data Safety Monitoring Board and Clinical Advisory Board.
• Provide medical oversight for current and future clinical trials, including safety monitoring, data analysis, and interpretation of clinical trial results
• Build and maintain strong relationships with key opinion leaders (KOLs) and academic institutions to support the company's scientific and clinical objectives
• Collaborate closely with other departments such as clinical operations, technical operations/CMC, translational research and regulatory affairs to ensure alignment on program objectives
• Lead the development of scientific publications, presentations, and educational materials related to Glycomine’s programs
• Provide medical, disease-specific, and development perspective into specific research programs or broader research initiatives
• Support start-up activities (informed consent forms, eCRF design, etc.) related to the assigned clinical studies
• Serve as primary medical point of contact for sites and PIs for the assigned studies, as applicable
• Interface with international regulatory authorities, as appropriate, in support of the development objectives for the compound or program

• M.D./DO or equivalent with rare disease, pediatric, or neuroscience experience preferred.
• Board certification in a specialty is highly desired
• 5+ years’ experience as a medical monitor in the pharmaceutical industry experience, including time managing clinical trials and/or clinical development program(s)
• Experience working collaboratively within a multi-disciplinary team of colleagues and proven ability to interact with external experts and investigators
• Experience in early-stage development programs
• Demonstrated command working with FDA, MHRA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies
• Effective oral and written communication skills are required, as are excellent interpersonal skills with demonstrated ability to work with a small growing team. Marked proficiency in clinical/medical writing
• Experience designing mid- and late-phase clinical trials and comfortability with advanced clinical trial design and statistical methodologies
• Capable of analyzing research data and publications; working knowledge of biostatistics; working knowledge of GCP, scientific and clinical research methods and clinical study design

All your information will be kept confidential according to EEO guidelines.