Associate Director, Clinical Operations

The role

The Associate Director, Clinical Operations will lead cross-functional study teams and manage the delivery of global clinical trials. This role involves overseeing CROs, managing budgets and timelines, and ensuring compliance with ICH/GCP guidelines.

What you will do

• Lead the cross-functional study team and engage in day-to-day clinical trial management.
• Contribute to clinical trial operational strategy and updates to leadership.
• Provide input into baseline budget and timeline development and management.
• Identify outsourcing needs and lead the evaluation, selection and management of CROs and other vendors.
• Review, contribute to and/or author study Protocol, Informed Consent Forms, Investigator Brochures, Clinical Study Reports and Regulatory submission documents.
• Conduct ongoing trial risk identification and analysis and develop mitigation strategies.
• Oversee clinical trials to ensure execution in compliance with metrics, timelines, budget, and quality standards.
• Lead feasibility assessment to select relevant regions and countries for the study.
• Oversee site evaluation and selection and liaise with clinical site staff and Investigators.
• Lead development and implementation of patient recruitment and retention strategies.

Required qualifications

• Bachelor’s degree in a relevant scientific or healthcare discipline
• 8+ years of clinical operations experience
• 4+ years as a clinical trial manager
• Experience leading cross-functional teams and planning and executing global clinical trials
• Experience managing global clinical operations for first-in-human to Phase 3 Programs from start-up to close out
• Experience managing clinical CRO and other vendors, budgets and timelines
• In depth knowledge of ICH/GCP guidelines
• Working knowledge of regulatory guidelines/directives
• Proficiency in trial management systems, IVRS/IWRS, eTMF, EDC, SmartSheets and Microsoft applications including Project, PowerPoint, Word and Excel
• Effective project management skills
• Cross-functional team leadership and organizational skills
• Ability to thrive in a fast-paced environment and manage multiple competing tasks

Nice to have

• FDA and other regulatory inspection experience
• Current rare disease experience
• Gene therapy experience

Benefits

• Group medical, vision, and dental coverage
• Group life and disability insurance
• 401(k) plan with company contribution
• Tuition reimbursement
• Annual incentive bonus
• Equity grants

Before you apply

• Interested individuals must apply directly to be considered for the opening

About the company

Tessera Therapeutics is pioneering Gene Writing, a biotechnology designed to write therapeutic messages into the genome to cure diseases at their source.