5 часов назад
Senior Medical Director - Medical Monitoring
200 000 - 28 500$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Medical Director - Medical Monitoring (Clinical Development): Ensuring subject safety and scientific integrity across clinical studies for therapies targeting rare and serious diseases, with an accent on medical monitoring, safety review, and clinical data interpretation. Focus on independently making study medical decisions, detecting emerging safety signals, supporting data monitoring committees, and shaping clinical development for transplant medicine.
Location: Remote within the continental US or hybrid at the Durham, NC office with 3 days onsite per week
Salary: $200,000.00–$285,00.00 annually
Company
develops pharmaceutical therapies for rare and serious diseases and technologies to expand the availability of transplantable organs.
What you will do
- Ensure subject safety and scientific integrity across allocated clinical studies in accordance with ICH GCP, regulatory guidance, and company SOPs.
- Provide medical expertise and timely guidance to clinical development teams, study sites, and internal and external partners.
- Review and approve protocols, informed consent materials, medical monitoring plans, statistical analysis plans, and final study reports.
- Evaluate serious adverse events, adverse events, laboratory data, and safety signal detection outputs.
- Support Data Monitoring Committees and participate in the review and interpretation of clinical study data.
- Document medical monitoring activities and provide clinical training to study teams and site personnel.
Requirements
- MD, DO, or foreign equivalent such as MBBS.
- 7+ years of relevant experience, including medical monitoring in pharmaceutical, biotechnology, or clinical research settings, or relevant physician experience combined with 2+ years of medical monitoring experience.
- Ability to make independent medical decisions and serve as the primary medical monitor.
- Clinical or medical monitoring experience in critical care, pulmonology, respiratory medicine, nephrology, internal medicine, hospital medicine, cardiology, or transplant medicine.
- Proficiency with Microsoft Office and excellent communication skills with strong scientific vocabulary.
Culture & Benefits
- Work environment focused on flexibility, balance, well-being, and advancing therapies for patients with rare diseases.
- Eligible employees may receive medical, dental, vision, and prescription coverage.
- Benefits may include wellness resources, 401(k), ESPP, paid time off, paid parental leave, and disability benefits.
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