Senior Director, Clinical Operations Business & Excellence

The role

The Senior Director will set the strategy for and lead a centralized Clinical Operations Business Office. This role establishes the operating model, governance, and portfolio-level performance to embed inspection readiness into clinical trial execution.

What you will do

• Set the strategy and lead the Business Office operating model
• Own the Business Office roadmap, annual objectives, and performance measures
• Lead resource and capability planning
• Oversee business negotiations for master service agreements and statements of work
• Own the centralized site contracting and budgeting operating model
• Provide senior-level vendor governance and partnership leadership
• Own the electronic trial master file governance strategy and business process
• Lead a portfolio-wide approach to continuous inspection readiness
• Set the Business Office approach to consistent, portfolio-wide risk-based quality management
• Lead the development, harmonization, adoption, and evaluation of standard operating procedures

Required qualifications

• BSc in a scientific, business, healthcare, or related discipline
• 12 or more years of progressively responsible experience in clinical operations, clinical business operations, or related functions within biotechnology or pharmaceutical organizations
• Experience with Inspection Preparation for pivotal programs
• Expertise in clinical sourcing, CRO and vendor governance, contract negotiation, and investigator site budgeting
• Experience with eTMF governance, inspection readiness, and clinical quality processes
• Strong working knowledge of ICH-GCP
• Track record of defining functional strategy, building scalable operating models, and delivering measurable results across multiple programs
• Success leading and developing senior professionals and matrixed teams

Nice to have

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

Benefits

• Annual bonus
• Equity compensation
• Competitive benefits package

About the company

Generate:Biomedicines is a clinical-stage generative biology company pioneering the AI revolution in drug design and development. The company integrates machine learning with large-scale experimentation to design proteins with defined biological intent.