Director – Medical Monitor

This is a fully remote position, open to applicants in California.

📋 Description

• Oversee ongoing medical monitoring and safety management for designated clinical trials, including real-time evaluation of safety data, adverse events, and laboratory results.

• Act as the main medical liaison for investigators and sites regarding eligibility, protocol interpretation, and patient management inquiries.

• Collaborate with investigators, advisors, and external experts to facilitate trial execution and clinical supervision.

• Review and evaluate adverse events and serious adverse events, including causality assessment, while assisting in safety signal detection in collaboration with Pharmacovigilance.

• Conduct continuous medical and clinical data reviews, encompassing data listings, protocol deviations, and eligibility checks, to ensure data integrity and participant safety.

• Provide clinical insights for protocols, amendments, informed consent documents, and other study-related materials.

• Analyze and interpret clinical and safety data to guide protocol modifications and trial-level decisions.

• Create and maintain medical monitoring plans and safety review procedures for assigned studies.

• Collaborate closely with Clinical Operations and CROs on trial execution, site management, and medical monitoring efforts.

• Work in partnership with Biometrics and Regulatory Affairs to confirm that clinical data meets statistical and regulatory standards.

• Engage closely with Translational Medicine, Safety/Pharmacovigilance, Regulatory Affairs, Biometrics, Medical Affairs, and CMC teams.

• Provide clinical insights into biomarker and safety strategies.

• Contribute to safety reports, DSURs, and responses to inquiries from health authorities.

• Offer clinical input for briefing documents, responses to regulatory queries, and clinical aspects of submissions.

• Assist in preparing for audits, inspections, and regulatory reviews.

⛳️ Requirements

• MD degree required.

• Proven medical monitoring experience in Phase 2-3 clinical trials within rheumatology or immunology fields is essential.

• A background in immunology, autoimmune diseases, rheumatology, or cell therapy is mandatory.

• Board certification as a rheumatologist is preferred.

• Over 5 years of clinical development and/or medical monitoring experience in biotechnology and/or pharmaceutical companies is required.

• Experience in supporting programs through critical clinical trial phases (e.g., study initiation, interim analyses, pivotal study execution).

• Strong capability to integrate clinical, safety, and scientific data into well-founded clinical and risk-benefit decisions.

• Comprehensive understanding of global clinical development, GCP, and patient safety regulations.

• Effective and credible communicator with investigators, cross-functional teams, senior management, and external experts.

• Familiarity with regulatory submissions (e.g., NDA, BLA, MAA) and support for health authority interactions.

• Ability to function independently as an individual contributor in a dynamic, fast-paced biotech setting.

🏝️ Benefits

• Medical, Dental, and Vision coverage.

• Group Life Insurance.

• Long Term Disability (LTD) benefits.

• 401(k) Retirement Plan.

• Employee Assistance Program (EAP).

• Flexible Spending Account (FSA).

• Paid Time Off (PTO).

• Company-paid holidays, including a week off during the year-end holiday period.

• Recognition program, Bonus.ly.