Head of Clinical Operations

Your experience includes…  

• MS, MBA, MPH or PhD with 15+ years of industry experience, 10+ years of clinical operations line management experience.  
• overseeing Phase 1-3 global clinical trials, patient registries, and support of regulatory engagements including IND/CTA and NDA/BLA/MAA to meet corporate goals. 
• Excellent understanding and demonstrated application of FDA guidelines, Good Clinical Practice (GCP), ICH and applicable Standard Operating Procedures. 
• Selecting and managing CROs (and other vendors) to meet or exceed corporate goals. 
• Building clinical operations infrastructure including recruiting, managing, mentoring, and training operations team members and drafting SOPs. 

You are interested in…  

• Leading all operational aspects of clinical studies and patient registries to achieve corporate goals for timelines, budget and quality. 
• Selecting and overseeing vendors, including Contract Research Organizations (CROs), laboratory vendors, and other third parties, to ensure they meet timelines, budgets, quality, compliance, and goals. 
• Reaching patient recruitment goals by leading the operational strategy for identifying, recruiting, and retaining trial subjects. 
• Preparing clinical operations plans, timelines/costs/resources, documents/presentations for internal planning and study execution. 
• Leading efforts to identify and build relationships with key investigators and trial sites to ensure successful execution of clinical studies in compliance with GCP/ICH, global regulatory and patient safety requirements. 
• Supporting regulatory submissions including timeline planning, data preparation, document generation, inspection readiness, and query responses. 
• Representing the company as a senior clinical operations spokesperson before appropriate scientific, medical, regulatory, and business associates. 

About you:  

You are a dynamic clinical operations leader who has experience providing strategic hands-on oversight of global clinical studies to support a growing pipeline of novel genetic medicines. You have experience leading a team of internal and external clinical operations professionals to meet aggressive timelines, manage budgets and select/oversee vendors. You are interested in supporting the planning, execution, oversight, monitoring, auditing and reporting of all phases of clinical trials.  

At Tessera, you will find a highly collaborative, matrixed environment defined by rapid scientific innovation and a mission-driven culture dedicated to transforming the lives of patients with devastating genetic diseases. You will make our mission possible by implementing state-of-the-art approaches to achieve operational excellence, optimize clinical trial efficiency, and accelerate the development of our gene therapies. 

Tessera leaders are empathetic and transparent coaches with a strong sense of integrity. They are committed to the growth and development of their teams, the organization and themselves. 

Leadership Structure:  

All inquiries regarding the posted position should be directed to the Talent Partner (see below). Interested individuals must apply directly to be considered for the opening.   

This position reports to: Dave Davidson - Chief Medical Officer 

David joined Tessera in 2021 as Chief Medical and Development Officer. David brings ove