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
- 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
- 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
- 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
- Works with Quality Assurance to resolve quality related issues with labeling
- 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
- 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 –
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