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Freelance Medical Director - 1.0 FTE

Position Summary

An experienced physician consultant is sought to provide medical oversight for ongoing global late-stage clinical trials in a urologic oncology indication. The role involves close collaboration with Clinical Operations and contract research organization (CRO) medical monitoring teams to support participant safety, protocol compliance, and high-quality clinical data generation. A key area of focus is eligibility assessment and the consistent application of medical decision-making across international study sites.

The consultant will work under the guidance of the study’s medical leadership and contribute to the successful execution of pivotal clinical development programs.

Key Responsibilities

Clinical Trial Medical Oversight

• Provide sponsor-level medical oversight for one or more ongoing global pivotal clinical studies.
• Support medical accountability for study conduct, protocol adherence, and consistency of clinical decision-making across regions.
• Contribute to the resolution of complex medical and operational issues affecting trial execution.

Medical Monitoring Collaboration

• Partner closely with CRO medical monitors and study teams.
• Review and provide input on key medical monitoring activities and outputs.
• Escalate and assist in resolving protocol deviations, safety concerns, and site-level medical questions.

Eligibility Review and Adjudication

• Lead or support subject eligibility review processes.
• Evaluate complex inclusion/exclusion criterion questions, borderline cases, and protocol interpretation issues.
• Ensure consistent application of eligibility requirements and appropriate documentation of medical decisions.

Protocol and Study Documentation Support

• Provide medical input into protocol amendments, clarifications, and operational guidance documents.
• Assess the appropriateness of eligibility criteria, assessment schedules, and safety monitoring procedures.
• Support study teams in implementing protocol updates and clarifications.

Clinical Data Review

• Utilize electronic data capture (EDC) and electronic case report form (eCRF) systems to review clinical data.
• Identify trends, inconsistencies, outliers, and potential safety or efficacy signals.
• Collaborate with Clinical Operations and Data Management on medical review plans and query strategies.

Safety Oversight

• Contribute to ongoing benefit-risk assessments.
• Review serious adverse events (SAEs), adverse events of special interest (AESIs), narratives, and aggregate safety outputs.
• Partner with Pharmacovigilance and CRO teams to support safety governance activities.

Site and Study Team Support

• Provide medical guidance to study teams and investigative sites on disease assessments, standards of care, study procedures, and protocol-required evaluations.
• Support timely and consistent responses to medical inquiries.

External Scientific Engagement

• Engage with investigators and external experts to obtain scientific and operational insights.
• Support feasibility assessments, interpretation of clinical findings, and issue resolution within established governance frameworks.

Inspection Readiness and Documentation

• Ensure medical oversight activities are appropriately documented and inspection-ready.
• Maintain clear records of medical decisions, eligibility assessments, and safety-related actions.

Required Qualifications

• Medical degree (MD or equivalent) required.
• Specialized training and/or significant clinical experience in oncology, urology, or a related therapeutic area strongly preferred.
• Deep expertise in a relevant oncology disease area, including clinical management pathways, risk stratification, and key clinical endpoints and assessments.
• Demonstrated experience providing sponsor-side medical oversight for interventional clinical trials, preferably global late-stage or pivotal studies.
• Experience with patient eligibility review and adjudication processes.
• Strong understanding of ICH-GCP guidelines and clinical safety oversight practices.
• Experience reviewing clinical data within EDC/eCRF systems and participating in medical data review activities.
• Established relationships within relevant investigator and key opinion leader (KOL) communities are advantageous.

Key Competencies

• Strong clinical judgment and ability to make consistent, evidence-based medical decisions.
• Ability to evaluate eligibility, protocol compliance, and patient safety issues in complex clinical scenarios.
• Effective collaborator with CRO partners, investigators, and multidisciplinary study teams.
• Proficiency in interpreting patient-level clinical trial data and identifying meaningful trends.
• Excellent scientific communication and documentation skills.
• Strong organizational skills with attention to detail and inspection-readiness requirements.
• Ability to operate effectively as a consultant within a matrixed, global environment.

Key Stakeholder Interfaces

Internal Stakeholders

• Clinical Operations
• Data Management
• Biostatistics/Biometrics
• Pharmacovigilance/Drug Safety
• Regulatory Affairs
• Quality Assurance
• Clinical Supply
• Study Leadership Teams

External Stakeholders

• CRO medical monitors and operational teams
• Investigators and study sites
• Central laboratory, imaging, and pathology vendors
• External scientific advisors and key opinion leaders (KOLs)