Senior Clinical Scientist/Clinical Monitor

Position Summary:  The Senior Clinical Scientist serves as the lead clinical scientist on assigned clinical trials, providing scientific and medical oversight to ensure high-quality trial conduct and data integrity. This role leads medical monitoring activities, collaborates closely with the CMO and clinical ops team, and partners cross-functionally both internally and externally with CROs to support protocol development, study execution, and delivery of clinical milestones.

Key Responsibilities:

• Serve as the lead clinical scientist providing scientific and medical oversight throughout the trial lifecycle.
• Lead and conduct medical monitoring, including review and interpretation of clinical data and assessment of medical and protocol deviations, in collaboration with the internal CMO, clinical team and external parties (eg CRO)
• Collaborate cross-functionally in the development of clinical protocols and related study documents, including but not limited to investigator brochures (IBs), development safety update reports (DSURs), informed consent forms (ICFs), protocols, protocol amendments, and Clinical Study Reports (CSRs).
• Support study planning, execution, and delivery of key milestones and deliverables.
• Participate in meetings with external vendors including but not limited to CRO, specialty labs, consultants, etc.
• Provide guidance to CRO and site personnel on the application of trial eligibility criteria.
• Participate in reviews of CRF design to ensure protocol-aligned data collection in collaboration with Clinical Operations Lead and CRO Data Management and Programming.
• Collaborate cross-functionally with monitoring of clinical and safety data outputs, ensuring completeness, accuracy, and data integrity
• Support CMO with study required drug safety reviews, Sponsor approvals of SUSAR reports working in collaboration with Clinical Operations on safety reconciliation preparedness for database lock and other milestones
• Provide scientific and execution-focused guidance and input to colleagues
• Participate in cross-functional discussions and decision-making, applying scientific judgment to support study goals and timelines.
• Contribute to publications and presentations

Core Skills and Competencies

• Demonstrated ability to lead and manage scientific activities for development of clinical protocols (Phase 1 through Phase 3) and execution of clinical development program.
• Strong knowledge of clinical research regulations and guidelines, including GCP and ICH.
• Proven ability to manage multiple competing priorities with strong planning, time management, and organizational skills.
• Excellent analytical skills, with the ability to critically interpret clinical trial data and synthesize clear, data-driven conclusions.
• Ability to effectively interact with stakeholders across departments, divisions, and the broader organization.
• Proactive mindset with strategic thinking and leadership focused on achieving study objectives.
• Skilled at influencing decisions across functional areas and with internal and external partners or vendors.
• Demonstrated ability to act independently and decisively when appropriate and required and at effectively in a matrix environment.
• Strong problem-solving, prioritization, conflict resolution, and critical-thinking abilities.
• Excellent communication, technical writing, and presentation skills.

Education and Experience

• Advanced degree (eg MD, DO, PhD or PharmD)
• Minimum 5 years experience conducting global clinical trials, including activities from trial initiation through database lock and study report writing
• Preferred: Prior experience in Infectious Disease clinical development, including hepatitis and respiratory trials preferred
• Experience with data review tools and interpreting statistical output