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Associate Director Precision Medicine - Clinical Diagnostics

$176.1k - $287.3k

Ladders

For our client, we are seeking a Associate Director Precision Medicine - Clinical Diagnostics to join the team of a leader in the Pharmaceuticals & Biotech space. This role will help shape how biomarker science is translated into clinically meaningful diagnostic strategies that support patient selection and drug development decisions. You will partner closely with translational, clinical, regulatory, and external development teams to advance companion diagnostic programs from strategy through validation. The position also plays a key role in aligning diagnostic milestones with clinical timelines while helping ensure global regulatory readiness and program execution. Location: Remote - US based candidates only, no visa sponsorship available Compensation: $176,100 – $287,300 annually Responsibilities Translate biomarker and mechanism-of-action data into diagnostic target product profiles. Collaborate with translational and clinical teams to design biomarker strategies for patient selection. Lead planning for analytical and clinical validation, linking assay performance to clinical endpoints. Establish global companion diagnostic strategy, aligning diagnostic milestones with clinical timelines. Select and manage in vitro diagnostic development partners, overseeing co-development scope and quality. Support global regulatory strategy and submissions in collaboration with regulatory teams. Ensure compliance with relevant standards and lead cross-functional working groups. Qualifications PhD or advanced degree in molecular biology, pathology, biomedical engineering, or a related field. 8+ years in diagnostics or translational research, including 4+ years leading companion diagnostic or IVD programs. Proven ability to translate biomarker science into validated assays for drug approvals. Familiarity with global companion diagnostic regulatory pathways, including FDA CDRH, EU IVDR, and PMDA. Strong communication skills for translating complex data to diverse audiences. Experience managing external partners and multi-workstream programs under QMS/GxP conditions. Benefits Remote work opportunity within the USA. Engagement in cutting-edge precision medicine initiatives. Collaboration with cross-functional teams and external partners. Opportunity to influence drug development decisions through diagnostics. Involvement in global regulatory strategy and submissions. Our client is an equal opportunity employer. We encourage you to apply even if you don’t meet every qualification—your background could be exactly what this team needs. #J-18808-Ljbffr Ladders

Vacancy posted 1 day ago
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