Associate Director, Clinical Scientist

The role

The Associate Director, Clinical Scientist will lead clinical trial execution, data review, and data analysis for a Phase 3 pivotal study. This role involves contributing to clinical strategy and driving the development of clinical and scientific processes.

What you will do

• Support Medical Directors for one or more Phase I–III clinical studies
• Lead studies across the full trial lifecycle from start-up through database lock and reporting
• Provide scientific input to efficacy and safety endpoint objectives
• Identify and provide solutions to data trends, inconsistencies, and potential issues
• Collaborate with cross-functional teams including Clinical Operations, Data Management, Biostatistics, Programming, Safety, and Regulatory
• Provide clinical oversight of study execution
• Author, review, and contribute to trial documents such as protocols, amendments, Investigator’s Brochures, and Clinical Study Reports
• Develop and deliver presentations to study teams
• Communicate the disease and treatment landscape to inform clinical trial development strategy
• Contribute to the development and standardization of templates, processes, infrastructure, and procedures

Required qualifications

• 5+ years of extensive hands-on experience supporting clinical trials in a clinical development role
• Experience working on study teams representing technical expertise
• Experience reviewing and interpreting clinical trial data listings
• Strong understanding of clinical trial conduct and cross-functional trial workflows
• Ability to work independently while navigating leadership demands
• Exceptional organizational, prioritization, leadership and execution skills
• Strong ability to communicate cross-functionally
• Ability to manage multiple studies and deadlines in a fast-paced environment
• Thorough understanding of the drug development process from IND/CTA through BLA/NDA submission
• Broad understanding of functional areas of drug development
• Ability to understand, interpret, and communicate clinical information
• RN, MS, PhD or PharmD, or equivalent with clinical research experience

Nice to have

• Advanced degree and/or professional certification/credentials

Benefits

• comprehensive health coverage
• flexible time off
• paid holidays
• year-end shutdown
• monthly wellness stipend
• generous 401(k) match
• tuition reimbursement
• commuter benefits
• disability and life insurance

Before you apply

• Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires

About the company

Kailera is working to advance novel therapies for obesity and related conditions. The company has an entrepreneurial spirit and a team-oriented culture.