Medical Monitor/Senior Medical Monitor, Hematology

Location: Somerville, Massachusetts, United States; based at headquarters in a flexible hybrid work environment. Approximately 10–20% travel may be required.

Salary: $270,000–$335,000 USD per year, plus annual incentive bonus and equity grants.

Company

A biotechnology company developing Gene Writing™ medicines designed to write therapeutic messages into the genome and address diseases at their source.

What you will do

• Provide medical oversight throughout interventional clinical studies and serve as the primary medical resource for investigators, CRO partners, and internal study teams.
• Review eligibility criteria, protocol deviations, adverse events, serious adverse events, laboratory data, safety signals, and emerging clinical findings.
• Support investigator meetings, study start-up, site training, investigator engagement, enrollment, and study milestones.
• Contribute to safety monitoring plans, benefit–risk assessments, Data Monitoring Committee materials, and regulatory safety reporting.
• Provide medical input into protocols, investigator brochures, informed consent forms, clinical study reports, and regulatory submissions.
• Help shape clinical development strategy for hematology programs, including potential applications in sickle cell disease and hematologic malignancies.

Requirements

• MD, MD/PhD, or equivalent medical degree with board certification in Hematology, dual Hematology/Oncology certification, or a related specialty with extensive Heme/Onc expertise.
• At least 3 years of biotechnology or pharmaceutical industry experience in clinical development with direct Medical Monitor experience, or extensive academic experience as a Principal Investigator of hematology/oncology clinical trials.
• Strong understanding of hematologic diseases, clinical trial methodology, safety monitoring, and interpretation of laboratory data, adverse events, and efficacy endpoints.
• Working knowledge of global regulatory requirements and ICH-GCP guidelines, including FDA and EMA requirements.
• Strong communication, collaboration, stakeholder management, clinical judgment, and patient-safety skills.

Nice to have

• Experience with rare hematologic disorders, genetic diseases, cell and gene therapies, genome editing, or other advanced therapeutics.
• Experience supporting IND/CTA submissions and interactions with regulatory agencies.
• Early-phase clinical development experience in Phase 1 and Phase 2 studies.
• Experience with Data Monitoring Committees and Safety Review Committees.
• A track record of collaboration across multidisciplinary clinical development teams.

Culture & Benefits

• Collaborative, fast-paced biotechnology environment focused on scientific rigor, patient safety, and operational excellence.
• Opportunities to engage with investigators, key opinion leaders, patient advocacy organizations, academic collaborators, and scientific forums.
• Medical, vision, and dental coverage.
• Group life and disability insurance, a 401(k) plan with company contribution, and tuition reimbursement.
• Annual incentive bonus and equity grants.