layiq

/la·yiq/adjective

worthy; deserving; fitting; suitable.

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

Associate Director / Director, Clinical Science at Immunome | LAYIQ

Strategic Leadership
Partner with Clinical Development leadership to define clinical strategy and contribute to integrated clinical development plans for assigned programs.
Provide scientific leadership for clinical study design (Phase 1–3), including endpoints, eligibility criteria, dose and regimen rationale, and biomarker strategy.
Serve as a key clinical development voice in program governance, enabling timely
, data-driven decisions that balance patient safety, scientific value, and development timelines.
Program Oversight and Execution
Lead the scientific execution of clinical studies, collaborating with Clinical Operations, Data Management, Biostatistics, Clinical Pharmacology, Translational Medicine, and Safety to ensure high-quality conduct.
Support medical monitoring activities, including review of safety data, protocol deviations, and emerging risk/benefit considerations, in partnership with Medical Directors and Pharmacovigilance.
Review and interpret clinical data (safety, efficacy, PK/PD, biomarkers), generate insights, and communicate results to internal teams and external stakeholders.
Vendor and Partner Management
Provide clinical development oversight of CROs and vendors (e.g., central labs, imaging, biomarkers) to ensure alignment with protocol requirements and data quality expectations.
Collaborate with external investigators, steering committees, and key opinion leaders to support study execution, recruitment, and scientific communication.
Regulatory and Documentation Support
Author, review, and contribute to clinical protocols, amendments, investigator brochures, informed consent forms, statistical analysis plans (in partnership), clinical study reports, and regulatory submissions (IND/CTA, annual reports, briefing packages).
Contribute to responses to health authority questions and support regulatory interactions by providing clear clinical development rationale and data interpretation.
Ensure all clinical development activities comply with GCP, applicable regulations, and internal quality standards.
Leadership and Collaboration
Lead, mentor, and develop clinical scientists and/or contractors, fostering a culture of scientific excellence, accountability, and collaboration.
Drive alignment across cross-functional teams, proactively identifying risks, proposing mitigation plans, and ensuring clear communication of priorities and decisions.
Support scientific dissemination through abstracts, manuscripts, presentations, and investigator meeting materials.

Associate Director / Director, Clinical Science

Employer job description

Responsibilities

Qualifications

Equal opportunity and accommodations

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