Medical Monitor/Senior Medical Monitor, Hematology

Medical Monitor/Senior Medical Monitor, Hematology

Somerville, Massachusetts, United States

Tessera is seeking an experienced physician with expertise in hematology to serve as the Medical Monitor for our innovative Gene Writing clinical programs. This individual will provide medical oversight across clinical studies, ensuring patient safety, protocol compliance, data integrity, and high-quality study execution while partnering closely with Clinical Operations, Safety, Regulatory, Biometrics, and Translational teams.

Reporting to the Chief Medical & Development Officer, the Medical Monitor will play a critical role in the design, conduct, and interpretation of early-stage clinical trials for novel genomic medicines targeting hematologic diseases, with indications that may include sickle cell disease and hematologic malignancies. The successful candidate will serve as the primary medical resource for investigators, CRO partners, and internal study teams while helping shape clinical development strategy through a deep understanding of hematologic disorders and emerging therapeutic approaches.

The position is based at Tessera's headquarters in Somerville, MA, with a flexible hybrid work environment. Approximately 1020% travel may be required.

Key Responsibilities

Medical Monitoring & Clinical Oversight

• Serve as the primary Medical Monitor for clinical studies, providing ongoing medical oversight throughout study conduct.
• Review eligibility criteria, protocol deviations, safety events, laboratory data, and emerging clinical findings to ensure patient safety and protocol compliance.
• Participate in investigator meetings, study start-up activities, site training, and ongoing investigator engagement.
• Collaborate with Clinical Operations and CRO partners to support efficient trial execution, enrollment, and study milestones.
• Provide timely medical review and adjudication of adverse events, serious adverse events, and other safety signals.

Safety Leadership

• Conduct regular review of accumulating safety data and contribute to benefit-risk assessments.
• Partner with Pharmacovigilance and Safety teams to identify, evaluate, and manage emerging safety concerns.
• Contribute to safety monitoring plans, Data Monitoring Committee materials, and regulatory safety reporting activities.
• Ensure studies are conducted in accordance with ICH-GCP, FDA, EMA, and other applicable regulatory requirements.

Clinical Development Contributions

• Provide medical input into clinical protocols, investigator brochures, informed consent forms, clinical study reports, and regulatory submissions.
• Support interpretation of clinical efficacy, pharmacodynamic, biomarker, and safety data.
• Collaborate with cross-functional teams to evaluate clinical findings and inform future development decisions.
• Contribute to study design discussions and clinical development strategy for hematology programs.

Scientific & External Engagement

• Develop and maintain expertise in hematologic diseases, emerging therapies, and competitive developments.
• Establish productive relationships with investigators, key opinion leaders, patient advocacy organizations, and academic collaborators.
• Represent Tessera at scientific meetings, advisory boards, and external forums.
• Support publication, abstract, and presentation development.

Cross-Functional Leadership

• Partner closely with Clinical Operations, Regulatory Affairs, Biometrics, Translational Medicine, Clinical Pharmacology, and Safety teams.
• Identify and proactively address operational, medical, and scientific risks.
• Foster a culture of scientific rigor, collaboration, patient focus, and operational excellence.

Qualifications

Required

• MD, MD/PhD, or equivalent medical degree with 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 academic expertise as a Principal Investigator of hematology/oncology clinical trials with a demonstrated track record of publications.
• 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.

Preferred

• 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.

What You'll Bring

• Passion for advancing transformative therapies for patients with serious hematologic diseases.
• Strong clinical judgment and commitment to patient safety.
• Ability to thrive in a fast-paced, innovative biotechnology environment.
• A collaborative mindset and dedication to scientific excellence.
• Commitment to the highest standards of ethics, compliance, and patient-centered clinical research.