8 часов назад
Senior Medical Director, Clinical Development Leader- GI (Remote)
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Medical Director, Clinical Development Leader- GI (Remote) (Clinical Development/GI): Providing strategic medical leadership for gastrointestinal clinical development programs, from protocol design through regulatory submission and post-approval activities, with an accent on patient safety, scientific rigor, and regulatory compliance. Focus on leading Phase I–III trials, interpreting efficacy and safety data, engaging regulatory authorities, and integrating emerging technologies such as AI in trial design.
Location: Remote in the United States
Company
is a privately held global healthcare company headquartered in Bologna and Milan, operating across more than 100 markets with a leading focus on gastrointestinal health.
What you will do
- Provide strategic clinical leadership and medical oversight for assigned gastrointestinal therapeutic-area programs.
- Lead medical input into clinical trial protocols, including eligibility criteria, treatment plans, and dosing strategies.
- Oversee clinical trials from concept through completion and evaluate efficacy, safety, and risk-mitigation data.
- Collaborate with Pharmacovigilance to monitor patient safety throughout clinical development.
- Engage regulatory authorities and ethics committees during submissions and address scientific or medical questions.
- Support Medical Affairs, Commercial, Product Management, and Business Development activities with medical expertise and asset validation.
Requirements
- MD required; PhD or comparable education is a plus.
- 10–15 years of clinical development experience in the pharmaceutical or biotechnology industry, including at least 5 years in a leadership role.
- Proven experience leading Phase I–III clinical trials and a solid understanding of drug development.
- Experience with IND, NDA, BLA, or MAA submissions and approvals, as well as clinical protocols, study reports, and IND, IB, and NDA/CTD documents.
- Experience working with Medical Affairs and Commercial groups and interacting with regulatory authorities and external stakeholders.
- Strong project management, communication, negotiation, analytical, collaboration, and cross-functional leadership skills.
Nice to have
- Experience in gastrointestinal clinical development.
- Experience with emerging technologies, including AI in trial design and real-world evidence.
Culture & Benefits
- Competitive salary and comprehensive benefits.
- Opportunities for professional growth and development.
- Culture focused on innovation, collaboration, diversity, and patient impact.
- Remote work arrangement for the United States-based role.
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