13 часов назад
Medical Director, GDS&RM (Oncology Pharmacovigilance)
257 500 - 333 500$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Medical Director, GDS&RM (Oncology Pharmacovigilance): Leading medical safety reviews, signal detection, benefit-risk assessments, and regulatory safety documentation for clinical and post-approval oncology products with an accent on pharmacovigilance, clinical trial safety, and cross-functional medical oversight. Focus on evaluating adverse event data, guiding safety teams, supporting regulatory submissions, and interpreting risks for immunotherapy development programs.
Location: Woburn, Massachusetts, United States; hybrid work with a minimum of 2 on-site days per week for local candidates
Salary: $257,500–$333,500 base pay per year, plus potential performance bonus, equity, and benefits.
Company
is a biotechnology company developing oncolytic immunotherapies designed to activate durable systemic anti-tumor responses.
What you will do
- Perform medical reviews of individual case safety reports from clinical trials and post-marketing sources.
- Lead or support safety signal detection, evaluation, interpretation, management, and communication for assigned products.
- Provide medical safety expertise to cross-functional clinical study and program teams.
- Conduct benefit-risk assessments and author safety assessment reports, regulatory responses, and periodic safety reports.
- Contribute medical input to protocols, statistical analysis plans, investigator materials, informed consent documents, clinical study reports, and IDMC charters.
- Guide safety teams, audits, inspections, risk management activities, SOP development, and collaboration with Medical Affairs and external partners.
Requirements
- MD, DO, MBBS, or equivalent non-US medical degree.
- At least 5 years of experience in drug safety, pharmacovigilance, or medical monitoring.
- Strong knowledge of general medicine, clinical practice, disease pathophysiology, and medical therapies.
- Working knowledge of GCP, ICH guidelines, and global regulatory requirements.
- Experience evaluating and interpreting safety data, including AEs and SAEs, and reviewing protocols, Investigator’s Brochures, Clinical Study Reports, and informed consent documents.
- Ability to work from the Woburn office at least 2 days per week for local candidates.
Nice to have
- Experience in oncology and immunotherapy.
- Prior NDA/BLA submission experience.
Culture & Benefits
- Mission-driven environment focused on transforming cancer treatment and improving patient outcomes.
- Collaborative culture built around unity, boldness, dedication, and candid communication.
- Medical, dental, and vision insurance.
- 401(k) match, flexible time off, and paid holidays including a year-end shutdown.
- Annual performance incentive bonus, new-hire equity, and ongoing performance-based equity opportunities.
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