Alios BioPharma, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Clinical Trial Supply Manager to be located in South San Francisco, CA. This position may also require up to 10% travel
Johnson & Johnson's Family of Companies are dedicated to addressing and solving the most important unmet medical needs of our time, including: oncology, immunology, neuroscience, infectious disease, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we develop sustainable, integrated healthcare solutions by working side-by-side with healthcare stakeholders, based on partnerships of trust and transparency.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer
The Clinical Trial Supply Manager will report directly to the Head of Clinical Operations, IDTA and will be responsible for the management of clinical supplies during the execution phase of clinical trials consistent with GMP guidelines.
The Clinical Trial Supply Manager will:
• Develop clinical trial material supply strategies to meet the needs of IDTA clinical trials programs
• Creation of study-specific procedures and forms for IMP activities (e.g. drug accountability logs, pharmacy manual, expiry update relabeling at sites/depots)
• Assess clinical study recruitment rates and ensure supply planning is adopted accordingly.
• Organize Pack, Labeling and Distribution planning
• Utilize business tools to manage inventories at depots and sites and ensure on-time delivery with minimal overage of clinical supplies.
• Vendor management: ongoing liaison with drug supply vendor regarding activities including packaging, labeling, QP release, dispatch (import/export licenses), returns and destruction
• Conduct issue resolution activities for supply aspects of clinical studies (e.g., packaging, distribution).
• Establish and modify trial specific distribution agreements
• Develop internal collaboration with stakeholders in Clinical Research and CM&C to ensure customer satisfaction.
• Interface with Service Provider team members, such as CRO Trial Managers, packaging/labeling/distribution and IVRS project managers.
• Manage trial supply budget.
• Develop working relationships within parent company Supply Management groups.
• A minimum of a Bachelor’s Degree is required.
• A minimum of 4 years of experience in a clinical supply related role is preferred
• Experience with clinical supply demand management tools is preferred (e.g., tcVisualize, IVRS, SAP)
• Experience with clinical supply pack/label/distribution, inventory management, and supply chain vendors is required
• Experience with clinical trial operations, project management, and pharma/bio research and development is preferred
• General knowledge of GMP principles is preferrred
• Intermediate to advanced software skills (e.g., Microsoft Excel, Powerpoint) is preferred
• Strong planning and cross-functional coordination skills is required
• Strong attention to detail is required
• Exceptional collaboration skills is required
• Excellent written and verbal communication skills is preferred
• Ability to work independently with some coaching is preferred
• Ability to multi-task and manage complexity is preferred
• Ability to work in a high pressure environment is preferred
• Ability to be solution oriented is preferred
United States-California-South San Francisco
Alios BioPharma, Inc. (6224)
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