Senior Director, Development - ECD and MCED Products

📋 Description

• Define and own the multi-year assay development strategy and technical lifecycle for the ECD and
• Take accountability for the phase-gated execution of all ECD and MCED programs, overseeing the
• Set team priorities, allocate people, budget, and laboratory resources, and make or recommend
• Establish the analytical verification and validation strategy for the portfolio to ensure robust
• Partner with clinical, medical, and biostatistics leaders to support approvable pivotal and
• Define regulatory pathways and evidence requirements for PMA submissions for ECD and MCED in an

🎯 Requirements

• Advanced degree (PhD, MD, or equivalent) in Molecular Biology, Biomedical Engineering, Life
• 7+ years of experience in IVD or diagnostic device development under design controls
• 7+ years of experience directing scientific or technical organizations, with 5+ years managing
• Demonstrated experience managing multiple concurrent development programs, with full accountability
• Deep technical expertise with complex NGS-based diagnostic assays, including assay design
• Demonstrated leadership of the technical and performance evidence for at least one FDA premarket

🎁 Benefits

• Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and
• Natera employees and their immediate families receive free testing in addition to fertility care
• Pregnancy and baby bonding leave
• 401k benefits
• Commuter benefits
• Generous employee referral program