Senior Manager, Precision Medicine - Clinical Diagnostics

For our client, we are seeking a Senior Manager, Precision Medicine - Clinical Diagnostics to join the team of a leader in the Pharmaceuticals & Biotech space. This role will drive companion diagnostic strategy in close alignment with clinical development, helping ensure diagnostic milestones support broader therapeutic programs. You will lead cross-functional execution across internal teams and external diagnostic partners, while advancing assay strategy, validation, and regulatory readiness. The position is highly collaborative and focused on bringing innovative diagnostic solutions through development, submission, and labeling to support patient care. Location: Remote - US based candidates only, no visa sponsorship available Compensation: $150,500 – $245,500 annually Responsibilities Execute end-to-end companion diagnostic strategy, aligning diagnostic milestones with clinical development Lead cross-functional teams, integrating workstreams and providing status updates Manage IVD partners, negotiating scope, timelines, and budgets Define assay intent and contribute to target product profiles for diagnostic platforms Embed companion diagnostic assays in trials, covering sampling and lab operations Partner with Regulatory on global submissions and labeling Ensure compliance with quality and regulatory frameworks Qualifications PhD in molecular biology, pathology, biomedical engineering, or equivalent 4+ years in diagnostics development, including 2+ years leading CDx/IVD programs Proven delivery of companion diagnostics aligned to drug approvals with successful validation Expertise in NGS, PCR, IHC, and immunoassays Strong grasp of global regulatory pathways for companion diagnostic labeling Excellent communication and leadership skills Benefits Remote work opportunity Contribution to a fast-growing, science-driven organization Meaningful impact on patient outcomes Collaboration with cross-functional teams Opportunity to lead innovative diagnostics projects 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.