Medical Director/Medical Monitor

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.