Clinical Operations Director – Oncology Asset Lead
Poland
Full Time
4 hours ago
$472,500 - $787,500 PLN
H1B Sponsor
Key skills
RLeadership
About this role
Role Overview
Lead asset-level clinical operations planning to maintain inspection readiness and regulatory deliverables.
Contribute to the development of the Clinical Development Plan and Integrated Evidence Plan.
Represent Global Clinical Operations functions at the asset level.
Coordinate cross-functional partners (clinical, biostatistics, clinical supplies, safety, and vendors) to support timely data deliveries.
Oversee vendor selection, contracting input, and operational oversight for outsourced clinical activities.
Model scenarios for optimal asset/study delivery linked to value drivers and drive decisions presented to governance boards.
Maintain and drive implementation of asset-level operational risk and mitigation plans.
Drive innovative approaches to study execution through external-facing advances in technology and sciences, by identifying and embracing risks and opportunities.
Provide strategic guidance and leadership to Study Delivery Teams to ensure clinical project goals are met.
Prepare and respond to data requests and contribute to materials for regulatory submissions.
Requirements
Advanced degree in MD, PharmD, PhD or related field, or equivalent clinical experience.
8+ years of clinical development experience, with oncology exposure.
3+ years of experience leading R&D interventional studies (Phase I, II, III).
Experience in managing cross-functional, matrixed teams with defined deliverables and performance outcomes.
Experience in clinical trial design, safety governance and regulatory submission requirements.
Experience in managing clinical research projects or equivalent in at least 2 different TA.
Experience in project development, quality requirements and associated processes.
Experience in clinical development and matrix management.
Experience converting scientific, strategic, and stakeholder input into documented action plans, timelines, and execution frameworks for the Asset team.
Experience applying defined prioritization criteria (risk, impact, resources, dependencies) to rank activities and coordinate stakeholder needs while aligning therapeutic area (TA) objectives with asset‑specific goals.
Experience developing and presenting structured reports, analyses, and recommendations that distill complex scientific and operational data into clear decision-ready formats for senior leadership.
Benefits
Private healthcare
Additional paid days off
Life insurance
Private pension plan
Fully paid parental leave & care of family member leave