DSMB Member, Physician

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

📋 Description

• Evaluate research submissions to ensure adherence to regulatory, ethical, and institutional standards.

• Prepare for and engage actively in scheduled meetings.

• Assess risks, benefits, and protective measures within research protocols.

• Detect instances of non-compliance, protocol deviations, or safety issues.

• Safeguard the confidentiality of sensitive research data.

• Offer recommendations regarding approval, modification, suspension, or termination of studies.

• Record reviews and decisions in line with institutional policies.

• Stay informed about relevant regulations, guidelines, and best practices.

• Analyze interim study data to ensure participant safety and data integrity.

• Evaluate adverse events, trends, and stopping rules.

• Advise on the continuation, modification, or termination of clinical trials.

• Review statistical analyses and safety monitoring strategies.

• Ensure confidentiality of interim data and discussions.

• Attend scheduled meetings, allocate time for independent reviews before meetings, and participate in ad hoc reviews or urgent issues as necessary.

⛳️ Requirements

• An advanced degree or equivalent experience in science, medicine, research ethics, regulatory affairs, biostatistics, veterinary medicine, biosafety, or a related field (requirements may differ by committee).

• A physician with proven experience in early-phase biologic product safety oversight, ideally involving first-in-human clinical trials.

• Experience in assessing safety data for allogeneic, cell-based, tissue-derived, extracellular vesicle (EV), or other advanced biologic therapies.

• Strong proficiency in evaluating immunogenicity, hypersensitivity reactions, and systemic safety signals during early clinical development.

• Previous experience serving on Data and Safety Monitoring Boards (DSMBs), Safety Review Committees (SRCs), or similar independent oversight bodies.

• Experience chairing safety reviews for Phase I clinical trials and leading multidisciplinary safety discussions.

• A background in immunology, clinical immunology, or a related specialty with expertise in immune-mediated adverse events.

• Capability to interpret emerging safety data from small patient cohorts and provide risk-based recommendations regarding study continuation and participant safety.

• Familiarity with regulatory considerations for first-in-human Investigational New Drug (IND) studies and advanced biologic products.

• Completion of required training and conflict-of-interest disclosures.

• Ability to maintain independence from study sponsors and investigators.

🏝️ Benefits

• Opportunity to contribute to cutting-edge research and clinical trials.

• Collaborative work environment with leading experts in the field.

• Professional development opportunities through training and workshops.

• Competitive compensation and benefits package.