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Medical Director, Clinical Development
@Glycomine
[Hiring] Medical Director, Clinical Development @Glycomine
Apr 05, 2025 - Glycomine is hiring a remote Medical Director, Clinical Development. 💸 Salary: unspecified. 📍Location: USA.
This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more.
Role Description
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.
- Direct medical responsibility for creating clinical development plans
- Designing clinical studies and writing protocols
- Providing CRO oversight and safety monitoring of clinical programs
- Contribute collaboratively toward the clinical aspects of research and early-stage development programs
- Provide insight into treatment indications, patient populations, study designs, and overall development strategies
- Support clinical development as the medical lead and medical monitor for clinical trials
- Work with cross-functional multidisciplinary study teams on clinical trial strategy, design, and execution
Responsibilities
- Contribute to the development and execution of comprehensive clinical development plans for Glycomine’s development programs
- Offer expert clinical advice, drawing on extensive clinical knowledge
- 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
- Contribute to the design and oversight of clinical trials, develop study protocols, case report forms, and informed consent documents
- Collaborate with the regulatory team to prepare and submit regulatory documents to health authorities
- 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
- Collaborate closely with other departments to ensure alignment on program objectives
- Lead the development of scientific publications, presentations, and educational materials
- Provide medical, disease-specific, and development perspective into specific research programs
- Support start-up activities related to the assigned clinical studies
- Serve as primary medical point of contact for sites and PIs for the assigned studies
- Interface with international regulatory authorities, as appropriate
Qualifications
- 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 working collaboratively within a multi-disciplinary team
- Experience in early-stage development programs
- Demonstrated command working with FDA, MHRA, and ICH GCP guidelines
- Effective oral and written communication skills
- Marked proficiency in clinical/medical writing
- Experience designing mid- and late-phase clinical trials
- Capable of analyzing research data and publications
- Working knowledge of biostatistics, GCP, scientific and clinical research methods
Additional Information
- All your information will be kept confidential according to EEO guidelines
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| 📍 | Be aware of the location restriction for this remote position: USA |
| ‼ | Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more. |
Back to Remote jobs >
All others
All others
|
Salary
💸
unspecified
|
Remote
Location
USA
|
|
Job Type
full-time
|
Posted
Apr 05, 2025
|
️
| 📍 | Be aware of the location restriction for this remote position: USA |
| ‼ | Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more. |
