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 currently located at 201 Brookline Avenue, in the Fenway area of Boston.
Tango Therapeutics has an exciting new opportunity to join the team as an Associate Director, Clinical Drug Supply to work across our global clinical programs as well as to work with CROs and CMOs. This first in role position reports into the SVP, Development Operations. You will work collaboratively across clinical teams for activities related to planning, forecasting, managing, and ensuring clinical supply for Tango’s clinical development programs.
· You will serve as the main point of contact for clinical supply vendors
· Manage the clinical supply for all clinical trials from end to end
· Collaborate with cross functional teams and CRO/vendor management around clinical supply deliverables and timelines
· Participate in the review of outsourcing strategies and proactively plan for clinical supply including packaging, labeling, storage, and distribution
· Manage clinical labeling requirements including expiry extension
· Manage inventory at depots and all clinical sites
· Represent drug supply management on cross-functional project teams and vendor/CRO operational meetings; 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 set-up, user requirements, and oversight of IRT for later phase trials
· Additional duties and responsibilities as required
What you bring:
· Bachelor’s Degree in life sciences, advanced degree preferred
· At least 7 years’ clinical supply experience in a clinical research environment, most of which should be in biotech/pharma; global clinical trial experience strongly preferred
· Manual forecasting experience
· Experience in early phase drug development including manual drug supply planning and tracking
· Ability to work collaboratively with clinical, GMP, CMC, and Quality
· Solid understanding of FDA and ICH GCP guidelines to ensure appropriate conduct of clinical studies in the United States related to clinical drug supply
· Good oral and written communication skills including review of clinical documents
· Good organizational skills and ability to work independently
· 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.