Tessera Therapeutics
Medical Monitor/Senior Medical Monitor, Hematology
Somerville, Massachusetts, United States · Senior
Sponsorship not specified$10k-$20kDetected 1 day ago
GCPStakeholder ManagementRecruitingPerformance ManagementClinical TrialsPharmacologyClinical Laboratory TechniquesFDA RegulatoryCRISPRPharmacovigilanceExperimental DesignAnimal StudiesLeadershipCommunicationCollaborationRegulatory Affairs
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Lottery odds (Level I)39
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About the role
- Position Overview Tessera is seeking an experienced physician with expertise in hematology to serve as the Medical Monitor for our innovative Gene Writing™ clinical programs.
- The position is based at Tessera's headquarters in Somerville, MA, with a flexible hybrid work environment.
- Ben is focused on aligning exceptional people with bold science - creating the structure, clarity, and culture that empower teams to scale effectively and achieve meaningful impact.
Responsibilities
- Collaborate with Clinical Operations and CRO partners to support efficient trial execution, enrollment, and study milestones.
- Partner with Pharmacovigilance and Safety teams to identify, evaluate, and manage emerging safety concerns.
- 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.
- Support publication, abstract, and presentation development.
- Partner closely with Clinical Operations, Regulatory Affairs, Biometrics, Translational Medicine, Clinical Pharmacology, and Safety teams.
- Tessera Therapeutics is pioneering Gene Writing™- a new biotechnology designed to offer scientists and clinicians the ability to write small and large therapeutic messages into the genome, thereby curing diseases at their source.
- Gene Writing holds the potential to become a new category in genetic medicine, building upon recent breakthroughs in gene therapy and gene editing while eliminating important limitations in their reach, utilization, and efficacy.
Requirements
- 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.
- 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.
- Ability to thrive in a fast-paced, innovative biotechnology environment.
- 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 communication, collaboration, and stakeholder management skills.
- Preferred
- What You'll Bring
Nice to have
- 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.
- 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.
- Establish productive relationships with investigators, key opinion leaders, patient advocacy organizations, and academic collaborators.
- Represent Tessera at scientific meetings, advisory boards, and external forums.
- Foster a culture of scientific rigor, collaboration, patient focus, and operational excellence.
Compensation
- The stated base salary range represents Tessera's good-faith estimate for this role.
- Actual compensation will be determined based on a number of factors, including but not limited to individual qualifications, years of relevant experience, internal compensation alignment, and external market data.
- Tessera offers a competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness, and financial security of our employees and their families.
- This position is also eligible for an annual incentive bonus and equity grants as part of Tessera's total rewards program.
- $270,000 - $335,000 USD
- Per Year Salary Range:
Benefits
- currently include group medical, vision, and dental coverage; group life and disability insurance; a 401(k) plan with company contribution; tuition reimbursement; and more.
- This position is also eligible for an annual incentive bonus and equity grants as part of Tessera's total rewards program.
- Medical Monitoring & Clinical Oversight
- Serve as the primary Medical Monitor for clinical studies, providing ongoing medical oversight throughout study conduct.
- 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.
- Provide medical input into clinical protocols, investigator brochures, informed consent forms, clinical study reports, and regulatory submissions.
- Identify and proactively address operational, medical, and scientific risks.
Equal opportunity
- Tessera is proud to be an Equal Opportunity Employer.
- All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, marital status, genetics, protected veteran status, citizenship status, sexual orientation, gender identity or expression, or any other characteristic identified by federal, state, or local laws where we operate.
- Tessera provides reasonable accommodations to qualified applicants and employees with disabilities.
- To begin an interactive dialogue with Tessera regarding a reasonable accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied, please contact the recruiter or Accommodations@tesseratx.com
Visa & Work Authorization
- ace, color, religion, age, sex, national origin, disability status, marital status, genetics, protected veteran status, citizenship status, sexual orientation, gender identity or expression, or any other characteristic i
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