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.
Tango’s labs and offices are located at 201 Brookline Avenue, in the Fenway area of Boston, Massachusetts
Summary
Tango Therapeutics is seeking a Manager/Senior Manager, Clinical Drug Supply to work across its clinical programs as well as to work with CROs and CMOs. This first in role position reports into the Development Operations organization. This position will work collaboratively across clinical teams for activities related to planning, managing, and ensuring clinical supply for Tango’s development programs.
Your Role:
- Drug Supply Management of first-in-human and early phase clinical trials of development candidates
- Support cross functional teams and CRO/vendor management related to clinical supply aspects
- Participate in the review of outsourcing strategies and proactively plans for clinical supply including packaging and labeling, storage, and distribution
- Manage clinical labeling requirements
- Manage inventory at depots and clinical sites
- Responsible for representing drug supply management on cross-functional project teams and Vendor/CRO operational meetings and ensuring compliance with operational standards and procedures
- Participate in the review of departmental SOPs and controlled documents to ensure compliance
- Develop and maintain strong, collaborative relationships with key stakeholders within cross functional teams including GMP and CMC
- Manage the pharmacy manual creation and management as applicable
- Support the set up, user requirements and oversight of IWRS for later phase trials
- Additional duties and responsibilities as required
What You Bring:
- · At least five years of clinical drug supply experience in a clinical research environment, most of which should be in industry; global clinical trial experience is strongly preferred
- · Bachelor’s Degree in a life-science-based subject, advanced degree preferred
- · Experience in early phase drug development including manual drug supply planning and tracking
- · Cross-collaboration proficiency with clinical, GMP, CMC and Quality
- · Solid understanding of FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies in the United States related to clinical drug supply
- · Good verbal and written communication skills including review of clinical documents
- · Good organizational skills and ability to work independently
- · Proven track record working within multi-disciplinary teams in the biotech or pharmaceutical industry
- · Attentive to detail and capable problem-solver
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.