Senior Manager, Precision Medicine – Clinical Diagnostics

This is a fully remote position, open to applicants in United States.

📋 Description

• Implement a comprehensive companion diagnostics strategy, ensuring alignment of diagnostic milestones with therapeutic clinical development and regulatory timelines.

• Lead interdisciplinary teams, integrate various workstreams, remove barriers, and provide status updates to governance bodies and senior leadership.

• Manage relationships with IVD partners, negotiating scope, timelines, budgets, and quality standards.

• Oversee co-development initiatives and manage Joint Steering Committees.

• Define the intent of assays and contribute to target product profiles for CDx platforms, including NGS, PCR, IHC, and immunoassays.

• Drive the processes of analytical and clinical validation.

• Incorporate CDx assays within clinical trials, addressing screening/stratification, sampling, site readiness, and laboratory operations.

• Collaborate with IVD Regulatory on global submissions, assisting with pre-submissions, labeling, and responses.

• Ensure adherence to ISO 13485/14971, CLSI, IVDR, and GCP standards.

• Maintain comprehensive documentation and readiness for audits.

• Work collaboratively across biomarker, clinical, regulatory, commercial, and IVD functions.

⛳️ Requirements

• PhD in molecular biology, pathology, biomedical engineering, or a related field.

• Over 4 years of experience in diagnostics development.

• At least 2 years of experience leading CDx/IVD programs within pharmaceutical or diagnostics organizations.

• Proven track record of delivering CDx aligned with drug approvals, including successful validation and regulatory submissions.

• Proficient in NGS, PCR, IHC, and immunoassays.

• Knowledgeable in validation standards and quality management systems.

• Strong understanding of global regulatory pathways, including FDA CDRH, EU IVDR, and PMDA, regarding CDx labeling.

• Exceptional communication, leadership, and stakeholder management abilities.

• Capable of delivering clear updates to executive-level audiences.

🏝️ Benefits

• Annual bonuses or alternative incentive plans.

• Equity awards.

• Pension or retirement benefits.

• Company match for 401(k) plans.

• Health and wellness programs.

• Access to fitness centers.

• Comprehensive medical, dental, vision, life, and disability insurance benefits.

• Paid time off.

• Family support benefits.

• Reasonable accommodations during the recruitment process, where necessary.