Manager, Clinical Supply
Location: Emeryville, CA
Department: Clinical Supply & Distribution
The Manager, Clinical Supplies independently coordinates clinical supply activities for clinical studies in support of development programs. These activities include review of clinical study protocols, design of clinical labels, preparation of packaging and labelling contracts, and forecasting and ordering supplies. Must coordinate the efforts of Clinical Supplies with Manufacturing, Clinical Operations, Quality Assurance, and Regulatory Affairs with the objective of establishing a plan to have clinical supplies available within the agreed time frame.
Essential Duties and responsibilities
- Represent Clinical Supply on internal and external cross functional team meetings to update teams on the supply readiness and report back to the team on the status of projects.
- Initiate and oversee the origination, proofing, and translation of clinical study labels, as required.
- Prepare documentation for and assist internal and external stakeholders with the import and export of clinical supplies to depots and study sites, as required.
- Facilitate Direct to Patient shipments and the returns from patients to sites.
- Extrapolate IMP requirements from clinical protocols; identify initial startup needs for country/site/subject.
- Monitor IMP for duration of study and ensure appropriate stock levels are available for study requirements.
- Prepare reports and documentation to facilitate decision making and to record transactions of all labeling campaign operations performed.
- Effectively coordinate the supply requirements for domestic and international studies, including scheduling of packaging/labelling activities.
- Manage drug supply delivery timelines with Clinical, manufacturing, QA and Regulatory Affairs, as required.
- Perform IMP reconciliation for clinical studies at study closeout.
- Review and update existing SOPs and identify the need for and assist in the establishment of new departmental procedures.
- Other duties as assigned
Core Competencies, Knowledge and Skill Requirements
- Effectively participates and presents at meetings and demonstrates facilitation and listening skills.
- Demonstrates planning, project management, negotiation, and presentation skills
- Works on routine assignments and applies knowledge and experience in learning new procedures.
- Comprehensive understanding and knowledge of the Investigational Product Supply Chain.
- Ability to handle multiple assignments and priorities simultaneously in a fluid environment with time pressures.
- Comprehensive understanding and be knowledgeable in development and oversight IRT requirements for drug supply management. Continue to monitor IRT after study start.
- Sound judgement, analytical, problem solving and decision-making skills.
- Comprehensive understanding and be knowledgeable in regulatory requirements, including GMPs and GCPs.
- Comprehensive understanding of the drug development process and requirements of IND/NDA submissions
- Knowledge cGMPs and relevant FDA Regulations essential.
- Ability to prioritize, plan and problem-solve.
- Ability to handle multiple projects and work in a team environment.
- Ability to operate, with composure and confidence, in a team or matrix environment.
- PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)
Communication & Interpersonal Skills
- Excellent verbal and written communication skills
- Ability to effectively collaborate in a dynamic environment and develop productive relationships with external vendors
- Effective influencing skills.
- BS Degree in scientific field (preferred), Project management, Supply Chain
- 5+ years of Clinical Supply / Clinical Packaging / Project Coordination experience in the pharmaceutical/device industry or CRO.
TRAVEL, PHYSICAL DEMANDS AND WORK ENVIRONMENT
- Regularly required to operate standard office equipment (personal computer, photocopy machine, etc.)
- Ability to work on a computer for extended periods of time.
- Regularly required to sit for long periods of time, and occasionally stand and walk.
- Regularly required to use hands to operate computer and other office equipment.
- Close vision required for computer usage.
- Occasionally required to stoop, kneel, climb and lift up to 20 pounds.
- Possibility of travel up to 10%.