Medical Monitor/Senior Medical Monitor, Hematology

The role

The Medical Monitor provides medical oversight for Gene Writing clinical programs. This person ensures patient safety, protocol compliance, and data integrity while partnering with cross-functional teams.

What you will do

• Provide ongoing medical oversight for clinical studies
• Review eligibility criteria, protocol deviations, safety events, and laboratory data
• Participate in investigator meetings, study start-up, and site training
• Collaborate with Clinical Operations and CRO partners
• Provide medical review and adjudication of adverse events and safety signals
• Conduct regular review of safety data and contribute to benefit-risk assessments
• Partner with Pharmacovigilance and Safety teams
• Contribute to safety monitoring plans and regulatory safety reporting
• Provide medical input into clinical protocols, investigator brochures, and regulatory submissions
• Represent Tessera at scientific meetings and advisory boards

Required qualifications

• MD, MD/PhD, or equivalent medical degree
• Board certification in Hematology, dual certification in Hematology/Oncology, or a related specialty with suitable expertise and extensive work experience in Heme/Onc
• Minimum 3 years of biotechnology or pharmaceutical industry experience in clinical development with direct experience serving as a Medical Monitor for interventional clinical studies, or extensive aca
• Strong understanding of hematologic diseases, clinical trial methodology, and safety monitoring
• Experience reviewing and interpreting clinical laboratory data, adverse events, and efficacy endpoints
• Working knowledge of global regulatory requirements and ICH-GCP guidelines
• Strong communication, collaboration, and stakeholder management skills

Nice to have

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

Benefits

• Group medical, vision, and dental coverage
• Group life and disability insurance
• 401(k) plan with company contribution
• Tuition reimbursement

About the company

Tessera Therapeutics is pioneering Gene Writing™ to write therapeutic messages into the genome to cure diseases at their source.