Manager of Clinical Supplies
Location: Bay Area, CA
Job Type: Direct Hire
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
- 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
- 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
- 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
- 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
- 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
- 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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