What are the responsibilities and job description for the VP, Clinical Operations position at Tango Therapeutics?
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
POSITION SUMMARY
Tango Therapeutics is seeking a Vice President of Clinical Operations responsible for the leadership of clinical programs, oversee CRO execution, and to support clinical operations initiatives. This position reports to the Head of Development Operations. This position will work collaboratively across the clinical portfolio to lead teams for clinical operations activities from early phase into later phase pivotal work. This position will have direct reports and ability to grow the Clinical Operations team as the programs advance.
RESPONSIBILITIES
· Program Management of clinical stage programs from an operational perspective
· Provide cross functional leadership and CRO/vendor management related to clinical trial operations aspects.
· Lead and manage teams in the selection and oversight of CROs and other vendors
· Develop and lead the review of clinical outsourcing strategies and plans
· Oversee of clinical trial budgets
· Responsible for representing Clinical Operations on cross-functional project teams and Vendor/CRO operational meetings and ensuring compliance with operational standards and procedures
· Lead monitoring oversight activities are conducted in accordance to ICH/GCP standards
· Along with other clinical team members, represent Tango externally to Investigators and trial sites
· Oversee activities leading to internal GCP audits and regulatory inspections related to clinical trial conduct
· Maintain oversight and participate in the review of departmental SOPs to ensure compliance
QUALIFICATIONS
· At least 15 years of global trial management experience in a clinical research environment, most of which should be in industry and with global trials
· Must have previous line management experience
· Advanced degree preferred or Bachelor’s in a science-based subject
· Oncology experience must include dose escalation and familiarity with immune oncology response criteria
· Solid experience in early phase drug development and proven track record of success
· Multi-dimensional Clinical operations background with capability of devising plans for operational challenges such as site activation, patient enrollment, monitoring oversight, protocol deviation management, data cleaning,
· Cross Collaboration proficiency with other functions such as Research, Drug Supply, and Finance.
· Thorough command of FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies in the United States, Europe and rest of world
· Experience in regulatory GCP inspections/audits
· Outstanding verbal and written communication skills including clinical authoring experience including protocols and investigator brochures
· Excellent organizational skills and ability to work independently
· Proven track record of effective leadership in the context of a multi-disciplinary team in the biotech or pharmaceutical industry
· Establishing and maintaining relationships with key opinion leaders; Some travel required
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.