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 Site Management Leader (SML) to oversee all site management and monitoring activities conducted by the CRO in a clinical trial. This role will be assigned to critical clinical trials of the Tango portfolio and serve as the primary contact between sponsor and CRO for site management aspects.
In a fast-paced, small biotech environment, the SML will operationally oversee and manage the end-to-end site management activities 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
- Serve as the primary liaison between CTT and CRO for all site management activities
- Oversee CRO performance for site management to ensure compliance with contractual obligations, timelines, and quality standards
- Lead or contribute to the development of the Site Management Oversight Plan and other trial-specific operational plans in collaboration with CTT
- Contribute to the development of a site-related RBQM framework to drive efficiency and ensure quality of critical site management aspects
- Identify trial-level risks and contribute to the development and implementation of risk management and mitigation strategies
- Manage and monitor site identification, feasibility assessments, and site selection processes
- Ensure site readiness for initiation, including training, documentation, and logistical preparedness
- Oversee and support site initiation visits (SIVs) and ensure timely site activation
- Monitor patient recruitment strategies and enrollment progress across clinical sites
- Ensure protocol compliance and data integrity through oversight of site monitoring activities
- Review monitoring visit reports and ensure timely resolution of site issues and follow-up actions
- Collaborate with CRO to address site-level issues. Escalate unresolved issues to CTL and CTT, as needed
- Ensure adherence to ICH GCP, regulatory requirements, and internal SOPs throughout trial conduct
- Participate in audits, inspections, and quality assurance activities related to site management
- Oversee site closure activities and ensure proper documentation and archiving
What You Bring
- 5+ years of trial management experience with 3+ years in site management. Leadership experience (preferred)
- Bachelor’s degree in Life Sciences, Pharmacy or related field
- Experience working in global clinical development organization
- Experience in Oncology development (preferred)
- Knowledge of ICH-GCP, FDA guidelines, EU CTR and other relevant guidelines
- Knowledge of trial/ site risk assessment and management
- Direct experience with site health authority inspections (FDA, EMA, MHRA, etc.) incl. sponsor GCP inspections (preferred)
- Experience in outsourcing and oversight
- 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
- 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
Skills Required
- 5+ years of trial management experience
- 3+ years in site management
- Bachelor's degree in Life Sciences, Pharmacy or related field
- Experience in Oncology development
- Knowledge of ICH-GCP, FDA guidelines, EU CTR and other relevant guidelines
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.
