Manager/Senior Manager Clinical Drug Supply

Job Title: Manager/Senior Manager Clinical Drug Supply

Job Number: 32279

Location: Boston, MA

Job Description

The Manager/Senior Manager, Clinical Drug Supply will work across clinical programs as well as work with CROs and CMOs. This 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 the companys development programs.

Responsibilities

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 forof 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

Required Skills

· 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