Manager of Clinical Supplies

Location: Bay Area, CA
Job Type: Direct Hire

Position Description:

We are seeking a knowledgeable and motivated professional capable of working effectively in a multi-disciplinary team environment. The successful candidate will assume a full-time employment role in the capacity of Manager of Clinical Supplies. Position will remain open until a suitable candidate is found.

Essential Duties and Job Functions:

• Works collaboratively with Formulation and Process Development, Materials Management, Statistician, Clinical Research Associate, Clinical Data Manager and other Clinical, Global Drug Safety, Regulatory and Project Management staff to meet project deliverables such as supplying clinical trial materials for clinical studies.
• Oversees and contributes to the completion of all technical and operational activities for a group of clinical trials for a compound/indication or equivalent through management of internal and external resources.
• Manages complex processes across functions, interacts effectively with the clinical protocol teams such as biostatistics and clinicians, materials management, quality assurance, formulation/process development, and regulatory affairs groups to provide input into the packaging and labeling configuration/labeling options.
• Responsible for people management, including but not limited to: employee development and goal setting, coaching/feedback, performance evaluations, resolution of any job task or interpersonal issues, and enhancement of productivity.
• Responsible for planning, implementing, and initiating activities on multiple projects related to the labeling and distribution of clinical supplies to ensure clinical supply study start dates are met.
• Works with clinical, formulation/process development, and materials management to forecast drug supply needs for clinical studies.
• Manages labeling contractor activities, including selection of contractor, clinical supplies, and provides timelines, and resolve issues.
• Manages budget for labeling/distribution and related project.
• Writes and review SOPs required for clinical labeling/distribution activities to ensure GMP compliance.
• Writes and reviews packaging and labeling batch records, and label artwork.
• Manages external vendor relationships and negotiate contracts; conduct vendor audits with Quality Assurance.
• Performs PPS, IQS, RCVS, EQMS and EBS (computerized software) transactions and prepares and/or approves purchase orders for specific programs.
• Oversees the management of clinical supply inventory at contractor facilities including movement of clinical supplies, monitoring of inventory levels, resolving discrepancies, etc.
• Directs activities within the clinical supplies group to meet company goals including labeling, production schedules, budgeting, training, performance reviews, etc.
• Works with Quality Assurance to resolve quality related issues with labeling vendors.
• Examines functional issues from a broader organization perspective.
• Determines the functions most critical to company success and supports priorities within functional area. Can lead two or more specific components of departmental strategic initiatives.

Knowledge, Experience and Skills:

• Excellent verbal, written, and interpersonal communication skills are required.
• Strong computer skills and strong organizational skills required.
• Must be able to anticipate client obstacles and difficulties and act upon this in order to meet goals.
• Must have the ability to write clear, concise and error-free documents.
• Must be able to exercise judgment within defined procedures and policies in order to determine and take appropriate action.
• Must possess a strong knowledge of the FDA, cGMP, and GCP standards as well as regulatory guidance documents such as Annex 13.

Specific Education & Experience Requirements:

• Typically requires a BS degree in science field preferably Pharmacy, or related scientific field and minimum 8 years of relevant experience industry experience preferably in formulation development, clinical/commercial manufacturing, and packaging clinical distribution.

Gateway Recruiting, INC – www.GatewayRecruiting.com – info@GatewayRecruiting.com

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