Medical Director - Senior Medical Director, Clinical Development

February 5

🍂 Massachusetts – Remote

Although this job is listed in Massachusetts, this company may be open to hiring remote in other states.

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

Apply Now

Receive Emails with Similar Jobs

Glycomine Inc.

WebsiteLinkedInAll Job Openings

Glycomine Inc. is focused on developing replacement therapies for rare genetic diseases, with the aim of significantly improving the quality of life for patients and their families. The company's primary focus is on PMM2-CDG, a rare genetic disorder of glycosylation, through its lead drug candidate, GLM101. This mannose-1-phosphate replacement therapy is currently in clinical trials across the U. S. and Europe. Glycomine is committed to providing disease-modifying treatments that go beyond existing therapies that only address symptoms. By advancing their innovative platform, Glycomine aims to restore the missing function caused by genetic mutations in patients with serious rare diseases.

2 - 10 employees

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

💰 Series B on 2021-06

📋 Description

• The Medical/Senior 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.

🎯 Requirements

• M.D./DO or equivalent with deep Neuroscience experience • 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