Clinical Trial Leader

Tango Therapeutics • Boston, MA

2d • Hybrid

About The Position

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. In a fast-paced, small biotech environment, the CTL will operationally lead the set-up, conduct and reporting of clinical trials as per approved timelines, budget, regulatory requirements, and internal standards. This individual will play a key role in the execution and delivery of clinical trial objectives. The ideal candidate is highly collaborative, detail-oriented, and comfortable operating in a hands-on environment, with a focus on building scalable processes, tools, and best practices to support efficient and compliant clinical trial execution.

Requirements

• 8+ years of trial management experience with 3+ years in trial leadership position.
• Bachelor’s degree in Life Sciences, Pharmacy or related field (required).
• Experience working in global clinical development organization.
• 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%)

Nice To Haves

• Advanced degree, e.g., MS, PharmD, PhD, MBA (preferred).
• Experience in Oncology development (preferred).
• Direct experience with health authority inspections (FDA, EMA, MHRA, etc.) incl. sponsor GCP inspections (preferred).

Responsibilities

• 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.
• Monitor 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.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior