Director / Sr. Director, Medical Monitor
Artiva Biotherapeutics
July 02, 2026
Remote friendly (San Diego, CA)
United States
Clinical Research and Development
Job Summary:
The Senior Director/Sr. Director, Medical Monitor provides medical oversight and safety monitoring across clinical trials, ensuring participant safety, data integrity, and regulatory compliance.
Duties/Responsibilities:
- Provide ongoing medical monitoring and safety oversight (real-time review of safety data, adverse events, and lab findings).
- Serve as primary medical point of contact for investigators/sites on eligibility, protocol interpretation, and patient management.
- Engage investigators, advisors, and external experts to support trial execution and clinical oversight.
- Review and assess adverse events/serious adverse events, including causality, and support safety signal detection with Pharmacovigilance.
- Conduct ongoing review of medical/clinical data (data listings, protocol deviations, eligibility) to ensure data quality and participant safety.
- Provide clinical input into protocols, amendments, informed consent forms, and related study documents.
- Develop and maintain medical monitoring plans and safety review processes.
- Partner with Clinical Operations and CROs on trial conduct, site management, and medical monitoring activities.
- Partner with Biometrics and Regulatory Affairs to support statistical and regulatory requirements.
- Collaborate with Translational Medicine, Safety/Pharmacovigilance, Regulatory Affairs, Biometrics, Medical Affairs, and CMC.
- Provide clinical input into biomarker and safety strategies; contribute to DSURs and health authority responses; support audits/inspections.
Requirements:
- MD required.
- Hands-on medical monitoring experience in Phase 2–3 trials in rheumatology or immunology required.
- Background in immunology, autoimmune disease, rheumatology, or cell therapy required.
- Rheumatologist with Board certification preferred.
- 5+ years clinical development and/or medical monitoring experience in biopharma.
- Experience through clinical trial milestones (start-up, interim analyses, pivotal conduct).
- Ability to integrate clinical, safety, and scientific data into sound risk-benefit decisions.
- Solid understanding of global clinical development and GCP/patient safety.
- Clear communicator with investigators, cross-functional teams, senior management, and external experts.
- Familiarity with regulatory submissions (e.g., NDA/BLA/MAA) and health authority interactions.
- Comfortable operating as an individual contributor in a lean, fast-moving biotech environment.
Benefits:
- Medical, Dental, and Vision; Group Life Insurance; Long Term Disability; 401(k); EAP; FSA; Paid Time Off; company paid holidays; Bonus.ly recognition program.
Base Salary: $250,000–$350,000 (varies by skills/experience).
The Senior Director/Sr. Director, Medical Monitor provides medical oversight and safety monitoring across clinical trials, ensuring participant safety, data integrity, and regulatory compliance.
Duties/Responsibilities:
- Provide ongoing medical monitoring and safety oversight (real-time review of safety data, adverse events, and lab findings).
- Serve as primary medical point of contact for investigators/sites on eligibility, protocol interpretation, and patient management.
- Engage investigators, advisors, and external experts to support trial execution and clinical oversight.
- Review and assess adverse events/serious adverse events, including causality, and support safety signal detection with Pharmacovigilance.
- Conduct ongoing review of medical/clinical data (data listings, protocol deviations, eligibility) to ensure data quality and participant safety.
- Provide clinical input into protocols, amendments, informed consent forms, and related study documents.
- Develop and maintain medical monitoring plans and safety review processes.
- Partner with Clinical Operations and CROs on trial conduct, site management, and medical monitoring activities.
- Partner with Biometrics and Regulatory Affairs to support statistical and regulatory requirements.
- Collaborate with Translational Medicine, Safety/Pharmacovigilance, Regulatory Affairs, Biometrics, Medical Affairs, and CMC.
- Provide clinical input into biomarker and safety strategies; contribute to DSURs and health authority responses; support audits/inspections.
Requirements:
- MD required.
- Hands-on medical monitoring experience in Phase 2–3 trials in rheumatology or immunology required.
- Background in immunology, autoimmune disease, rheumatology, or cell therapy required.
- Rheumatologist with Board certification preferred.
- 5+ years clinical development and/or medical monitoring experience in biopharma.
- Experience through clinical trial milestones (start-up, interim analyses, pivotal conduct).
- Ability to integrate clinical, safety, and scientific data into sound risk-benefit decisions.
- Solid understanding of global clinical development and GCP/patient safety.
- Clear communicator with investigators, cross-functional teams, senior management, and external experts.
- Familiarity with regulatory submissions (e.g., NDA/BLA/MAA) and health authority interactions.
- Comfortable operating as an individual contributor in a lean, fast-moving biotech environment.
Benefits:
- Medical, Dental, and Vision; Group Life Insurance; Long Term Disability; 401(k); EAP; FSA; Paid Time Off; company paid holidays; Bonus.ly recognition program.
Base Salary: $250,000–$350,000 (varies by skills/experience).