[Hiring] DSMB Member - Physician @Sitero LLC

Role Description

The Research Compliance Committee Member serves as a subject-matter contributor responsible for reviewing research protocols, monitoring regulatory compliance, and ensuring protection of research participants, animals, data integrity, and biosafety standards. The role supports ethical, scientific, and regulatory oversight across multiple institutional review and monitoring committees. Members are expected to apply regulatory knowledge, professional judgment, and independence to ensure institutional and federal compliance standards are met.

Core Responsibilities (Applicable to All Committees):

• Review research submissions for regulatory, ethical, and institutional compliance.
• Prepare for and actively participate in scheduled meetings.
• Evaluate risks, benefits, and safeguards within research protocols.
• Identify non-compliance, protocol deviations, or safety concerns.
• Maintain confidentiality of sensitive research information.
• Provide recommendations for approval, modification, suspension, or termination of studies.
• Document reviews and determinations in accordance with institutional policies.
• Remain current with applicable regulations, guidance, and best practices.
• Complete required training and conflict-of-interest disclosures.

Data Safety Monitoring Board / Data Monitoring Committee (DSMB/DMC):

• Review interim study data for participant safety and data integrity.
• Assess adverse events, trends, and stopping rules.
• Recommend continuation, modification, or termination of trials.
• Maintain independence from study sponsors and investigators.
• Evaluate statistical analyses and safety monitoring plans.
• Ensure confidentiality of interim data and deliberations.

Qualifications

• Advanced degree or equivalent experience in science, medicine, research ethics, regulatory affairs, biostatistics, veterinary medicine, biosafety, or related field (requirements vary by committee).

Requirements

• Physician with demonstrated experience in early-phase biologic product safety oversight, preferably involving first-in-human clinical trials.
• Experience evaluating safety data for allogeneic, cell-based, tissue-derived, extracellular vesicle (EV), or other advanced biologic therapies.
• Strong expertise in assessing immunogenicity, hypersensitivity reactions, and systemic safety signals during early clinical development.
• Prior experience serving on Data and Safety Monitoring Boards (DSMBs), Safety Review Committees (SRCs), or similar independent oversight committees.
• Experience chairing Phase I clinical trial safety reviews and leading multidisciplinary safety discussions.
• Background in immunology, clinical immunology, or a related specialty with expertise in immune-mediated adverse events.
• Ability to interpret emerging safety data from small patient cohorts and make 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.

Company Description

Sitero is an emerging leader in Clinical services and software solutions for the life sciences industry. We have experience and expertise in a diverse range of therapeutic areas and focus on innovative, technology-enabled solutions that allow our clients to focus on their core strengths. For early phase studies through Phase III clinical trials, our experienced team delivers high-touch services and technology to ensure the safety of all stakeholders across the clinical research community with an emphasis on ethics, compliance, and innovation.