Medical Director/Medical Monitor
Location: Boston, MA (Hybrid)
We are seeking an experienced Medical Director (Medical Monitor) to provide strategic and hands-on medical leadership to help drive the clinical development.
Some of the responsibilities include:
- Supervise clinical trials, ensuring SOPs, GCPs and following regulatory requirements.
- Design, implement clinical trials in the oncology space based on ICH-GCP and research guidelines.
- Serve as Medical Monitor for oncology clinical trials, providing medical oversight and ensuring patient safety.
- Review and assess SAEs, AESIs, and safety trends, partnering with Pharmacovigilance on signal detection and benefit–risk evaluation.
- Provide medical input into protocol design, dose escalation decisions, and safety monitoring plans.
- Contribute to clinical and regulatory documents (protocols, IBs, ICFs, CSRs) and support health authority interactions.
- Collaborate cross-functionally with Clinical Operations, Regulatory Affairs, Biometrics, and Translational Medicine.
- Engage with investigators, KOLs, and study sites to ensure high-quality trial execution and scientific alignment.
Requirements:
- MD or DO (or international equivalent) with board certification or eligibility.
- 4+ years of clinical trial experience in oncology/hematology, including medical monitoring responsibilities.
- Strong understanding of oncology drug development, safety assessment, and global regulatory requirements.
- Experience reviewing and managing SAEs, DLTs, and safety narratives.
- Excellent communication skills with the ability to engage internal teams, investigators, and regulators.
- Prior experience in biotech or emerging pharmaceutical companies.
- Good communication with internal and external partners/stakeholders.
Offer:
- Competitive salary ($200-300k)
- Professional development and potential for upward career growth.
- Impact in shaping regulatory strategy.