- Oversee all clinical functions and own the clinical lifecycle end-to-end, with an immediate focus on Clinical Operations.
- Oversee and lead execution of multi-national industry-sponsored clinical trials in partnership with CROs, specialized vendors, and consultants.
- Manage study design, site strategy, patient recruitment, and data quality to ensure regulatory and product performance goals are met.
- Lead regulatory strategy and execution, including IDE and other submissions for future products.
- Represent Motif directly with FDA and other regulatory bodies, including pre-submission meetings.
- Directly manage clinical and regulatory personnel, including hiring, onboarding, training, and performance management.
- Partner with cross-functional teams to ensure study design supports product development and market access strategy.
GCP