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Tessera Therapeutics

Gene Writing platform enabling precise edits

Medical Monitor/Senior Medical Monitor - Hematology

Clinical Research OperationsConfirmed live in the last 24 hours
Full-timeSomerville, MA, USA

About the Job

Requirements

  • 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.
  • At least 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 publication record.
  • 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.

Responsibilities

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

Desired Qualifications

  • 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.

About the Company

Tessera Therapeutics

Gene Writing platform enabling precise edits

Tessera Therapeutics focuses on genetic medicine by developing Gene Writing, a platform that makes precise and permanent changes to the human genome in cells. Its technology can perform both small and large genetic alterations, enabling targeted edits at the source of genetic diseases. The product works through a gene writing system that researchers and clinicians can apply to modify DNA sequences, with the aim of correcting disease-causing mutations. What sets Tessera apart is its emphasis on permanent, in vivo genome edits and a platform-driven approach supported by partnerships and licensing, rather than selling a single product. Revenue comes from collaborations with research institutions and pharmaceutical companies, licensing the Gene Writing technology, and potentially transferring proprietary tools to other biotech and healthcare organizations. The overarching goal is to cure genetic diseases by rewriting the genetic code, bringing about lasting therapeutic changes.

Company size
51-200
Company stage
Late Stage VC
Total funding
$682.7M
Headquarters
Somerville, MA
Founded
2018

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