Clinical Trial Leader

Summary

We are seeking a Clinical Trial Leader (CTL) to lead cross-functional clinical trial teams (CTTs) in the execution of clinical trials of Tango’s portfolio. This role will chair the CTT and represent the cross-functional team to internal governance bodies. The CTL will be an internal escalation point for other CTT members.

Your Role

• Lead cross-functional Clinical Trial Team (CTT) in the planning, execution, and reporting of outsourced clinical trial.
• Provide regular updates to internal governance bodies.
• Serve as the primary liaison between the sponsor and CRO to ensure alignment of trial objectives, timelines, and deliverables.
• Oversee CRO performance, ensuring adherence to scope, budget, and timelines.
• Contribute to protocol development and review of key study documents (e.g., ICFs, CRFs, monitoring plans).
• Lead the development of trial-specific plans including risk management, communication, and oversight plans.
• Support site selection and feasibility assessments in collaboration with CRO and internal stakeholders.
• Maintain trial progress through metrics and KPIs.
• In collaboration with Operational Excellence and Compliance, define an optimal RBQM framework to efficiently control quality throughout the trial.
• Proactively identify risks and issues and support the development and implementation of mitigation strategies and action plans.
• Ensure timely delivery of trial milestones including patient recruitment, data collection, and interim analyses.
• Manage trial budgets, change orders, and invoice reconciliation in collaboration with vendor management and finance.
• Ensure study conduct in compliance with ICH GCP, ISO standards, regulatory requirements, and internal standards.
• Participate in audits and inspections. Ensure timely resolution of findings.
• Review and approve essential documents and study deliverables.
• Oversee database lock, clinical study report (CSR) development, and study close-out activities.
• Contribute to regulatory submissions and responses as needed.

What You Bring

• 8+ years of trial management experience with 3+ years in trial leadership position.
• Bachelor’s degree in Life Sciences, Pharmacy or related field (required).
• Advanced degree, e.g., MS, PharmD, PhD, MBA (preferred).
• Experience working in global clinical development organization.
• Experience in Oncology development (preferred).
• Direct experience with health authority inspections (FDA, EMA, MHRA, etc.) incl. sponsor GCP inspections (preferred).
• Experience in outsourcing and oversight.
• Knowledge of ICH GCP, FDA guidelines, EU CTR and other relevant guidelines.
• Knowledge of financial planning, tracking, and reporting.
• Knowledge of trial risk assessment and management.
• Familiarity with clinical trial systems (e.g., CTMS, eTMF, EDC, IRT, eCOA) and operational metrics, KPIs, and KRIs.
• Strong vendor management and project management skills.
• Excellent leadership skills with the ability to lead cross-functional teams.
• Strong interpersonal and communication skills.
• Strong analytical thinking and decision-making capabilities.
• Willingness to travel, as required (typically 10–20%).

About the Role

Tango Therapeutics is a biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer. Tango leverages the genetic principle of synthetic lethality to discover and develop therapies that take aim at critical targets in cancer.

Benefits

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Pay

$160,000 - $241,000 USD