layiq

/la·yiq/adjective

worthy; deserving; fitting; suitable.

A role, opportunity, or path that merits attention, time, and pursuit.

Medical Director / Senior Medical Director, Clinical Development at Immunome | LAYIQ

Medical Monitoring and Patient Safety
Serve as the primary Medical Monitor for global clinical studies.
Provide ongoing medical review of safety, efficacy, and eligibility data.
Evaluate and assess serious adverse events (SAEs), adverse events of special interest (AESIs), and emerging safety signals.
Collaborate with Pharmacovigilance to ensure timely safety assessment, signal detection, and risk management activities.
Participate in Safety Review Committees, Data Monitoring Committees, and other governance forums as needed.
Ensure subject safety remains the primary consideration in study conduct and decision-making.
Clinical Trial Conduct
Provide medical oversight of study execution from initiation through database lock and study reporting.
Support protocol development, protocol amendments, informed consent forms, and study-related documents.
Review protocol deviations, eligibility questions, endpoint assessments, and other medically relevant study issues.
Partner with Clinical Operations to address site-level medical questions and enrollment challenges.
Assist with development and maintenance of study training materials.
Investigator and External Engagement
Serve as a primary medical contact for investigators and study sites.
Participate in investigator meetings, site initiation visits, and key study governance meetings.
Support interactions with key opinion leaders and external experts.
Contribute to advisory boards and scientific discussions relevant to the development program.
Data Review and Interpretation
Conduct ongoing review of accumulating safety and efficacy data.
Collaborate with Clinical Scientists and Biostatistics to identify trends, data quality issues, and emerging clinical insights.
Participate in blinded and unblinded data review activities as appropriate.
Contribute to interpretation of study results and preparation of clinical study reports, publications, and scientific presentations.
Regulatory and Cross-Functional Leadership
Support preparation of regulatory submissions and health authority interactions.
Contribute clinical input into briefing books, responses to regulatory questions, and inspection readiness activities.
Collaborate with Regulatory Affairs, Clinical Pharmacology, Translational Medicine, Biometrics, and Commercial colleagues to support integrated product development.
Present clinical updates and recommendations to internal governance committees and senior leadership.

Medical Director / Senior Medical Director, Clinical Development

Employer job description

Responsibilities

Qualifications

Equal opportunity and accommodations

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