Manager/Sr Manager
Clinical Drug Supply
Posted on 1/12/2023
Dorchester, Boston, MA, USA
Experience Level
  • 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
  • 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
Tango Therapeutics

51-200 employees