Clinical Trial Leader

Posted 15 Days Ago
Be an Early Applicant
Boston, MA, USA
In-Office
160K-241K Annually
Senior level
Biotech
The Role
Lead cross-functional clinical trial teams, oversee trial execution, manage budgets and timelines, and ensure compliance with regulations.
Summary Generated by Built In

Company Overview

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.

Using an approach that starts and ends with patients, Tango leverages the genetic principle of synthetic lethality to discover and develop therapies that take aim at critical targets in cancer.

This includes expanding the universe of precision oncology targets into novel areas such as tumor suppressor gene loss and their contribution to the ability of cancer cells to evade immune cell killing.

The Tango labs and offices are located at 201 Brookline Avenue, in the Fenway area of Boston, Massachusetts.

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.

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.

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.
  • 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.

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%)

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.

 


#LI-Hybrid


Salary range
$160,000$241,000 USD

Skills Required

  • 8+ years of trial management experience
  • 3+ years in trial leadership position
  • Bachelor's degree in Life Sciences, Pharmacy or related field
  • Experience working in global clinical development organization
  • Experience in Oncology development
  • Experience with health authority inspections
  • Experience in outsourcing and oversight
  • Knowledge of ICH GCP and FDA guidelines
  • Strong vendor management and project management skills
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The Company
HQ: Boston, Massachusetts
157 Employees
Year Founded: 2017

What We Do

Tango Therapeutics is a biotechnology company discovering and developing novel medicines targeting cancer vulnerabilities to deliver transformational new therapies for patients. Tango was launched in 2017 with a $55 million Series A investment from Third Rock Ventures. The company has established a robust product engine that leverages advances in DNA sequencing and CRISPR-based target discovery to generate breakthrough medicines that have the potential to provide deeper, more sustained benefit than today’s targeted therapies, and extend the benefit of available immuno-oncology agents. Tango Therapeutics is focused on three areas of drug development, each in well-defined patient populations currently lacking effective treatment options, and each with hallmarks of cancer that have not been targeted yet. These include: loss of tumor suppressor gene function; multiple oncogenic drivers; and immune evasion. What fuels each of Tango’s programs is an increasingly sophisticated ability to utilize synthetic lethality - the interaction between two genes that causes cell death when both are inactivated. In cancer cells, one of these genes is inactivated by mutation; the other will be inactivated by a drug. This approach leaves normal cells largely unaffected, with the potential to greatly enhance anti-tumor efficacy and reduce associated toxicity. Tango’s success will be driven by its depth of understanding of the genetic subtypes of cancer, and corresponding insights into novel drug targets and combinations uniquely relevant to each subtype. By shaping discovery efforts in this way, Tango has the potential to reach the clinic quickly, and with a clear plan for identifying the patients most likely to benefit from each new treatment, an approach that could increase both speed and probability of success in translating novel target discoveries into transformational new medicines for patients.

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