Senior Director, Clinical Operations Business & Excellence

Responsibilities

• Set strategy and lead the centralized Clinical Business Office operating model
• Oversee clinical sourcing, CRO and vendor governance, and complex contract negotiations
• Own site contracting and investigator budgeting operating model
• Own eTMF governance strategy and portfolio-wide continuous inspection readiness
• Lead Business Office support for audits, inspections and CAPA delivery with Quality
• Establish risk-based quality management and monitoring oversight standards
• Own SOP framework and digital enablement roadmap for the Business Office
• Build and develop a high-performing cross-functional leadership team

Requirements

• BSc in a scientific, business, healthcare or related discipline
• 12+ years progressive experience in clinical operations within biotech or pharma
• Inspection preparation experience for pivotal programs
• Expertise in CRO governance, contract negotiation and site budgeting
• Experience with eTMF governance and ICH-GCP practice
• Track record of building scalable operating models across multiple programs
• Experience leading and developing senior professionals and matrixed teams

Preferred Qualifications

• Advanced degree such as MBA, MS, PhD or PharmD

About the Company

• Clinical-stage generative biology company applying machine learning to protein-based drug design.
• Founded in 2018 with a multi-disease clinical and preclinical pipeline.