Manager, Clinical Supply Chain
|Title:||Manager, Clinical Supply Chain|
|Department:||Manufacturing and Product Supply|
|Job Type:||Exempt (salaried)|
|Location:||Exton, PA USA|
Accountable for uninterrupted supply of investigational medicinal products, placebo and comparators to clinical sites, depots and patients (US and ex-US).
- Manages the clinical supply chain for assigned clinical studies, including 3rd party manufacturing sites and delivery chain
- Owns clinical supply plan, with full understanding of demand, supply chain constraints (e.g., import / export licenses, shelf life, CMO capacity), inventory, cost of clinical materials, and critical processes (e.g., returns and destruction, ancillary supplies such as containers and cooler bags)
- Works collaboratively with R&D, clinical operations teams, and CMOs to ensure a robust planning process
- Manages clinical supply and distribution issues (e.g., shipment delays, in-transit temp excursions) with timely analysis, streamlined communication with key stakeholders, escalation, and resolution
- Provides long-term clinical supply and inventory projections
- This position is located in Exton, PA
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
- Coordinates supply chain operations in supporting multiple clinical studies in US/ex-US countries to meet project timelines
- Develops clear, consistent supply plans for clinical products, and closely monitors supply status including providing reports to management team as needed
- Works closely with CMOs/CROs to manage production of clinical supplies (including label/pack activities) to ensure timely distribution of products to customers
- Manages transactional activities at CMOs related to clinical supply (e.g., PO’s, invoice reconciliation, approval of quotes)
- Manages shipping (including cold chain) and distribution logistics including coordination of shipment requests, deliveries, import/export licenses, and in-transit status
- Works closely with clinical operations teams to ensure their needs are met a timely manner
- Supports regulatory filings as needed
- Leads meetings needed to support supply and demand planning processes as required
- Monitors adherence to clinical supply budget and manages travel budget within allowed limits
Note that reasonable accommodations will be made to the extent required by federal and state law to enable persons with disabilities to perform the essential functions of the
None at the present time.
EDUCATION and/or EXPERIENCE
- BS/BA major in life sciences
- Minimum 5 years in pharmaceutical or biotech industry experience in clinical supply chain operations (biologics preferred)
- Good understanding of ERP systems/implementation (such as SAP for supply chain)
- In-depth knowledge of clinical supply chain management including using IVR/IWR programs for managing clinical supplies
- Working knowledge of logistics compliance including import/export regulations
- Broad understanding of regulatory and quality requirements for biopharmaceutical products
- Excellent verbal and written communication skills
- 10 to 15% travel required (domestic or international)
- Cross-functional clinical supply chain / manufacturing experience preferably at various levels, (e.g. materials manager, demand manager, clinical operations manager)
- Systems knowledge: Knowledge of planning systems in general is a basic pre-requisite. Experience in IVR / IWR systems and enterprise planning systems is preferred.
- Knowledge of clinical production, logistics operations and supply chain processes is required.
- Able to anticipate cross-functional impacts and reach out to appropriate stakeholders when necessary to inform them of impacts.
- Must be a strong team player that builds relationships based on trust.
- Able to work effectively with necessary stakeholders
- Able to influence and work with others within team to drive business results
- Able to work with multiple variables and data to drive management decision making
- Able to model different types of supply and distribution scenarios using diverse data sources to develop options
- Able to develop key insights from data, frame effectively to support an argument, and use to drive decisions; able to strike good balance between quantitative and qualitative data sources
- Able to define problems, collect data, establish facts, identify feasible options, and draw valid conclusions
Note that reasonable accommodations will be made to the extent required by federal and state law to enable persons with disabilities to perform the essential functions of the position.
This opening is closed and is no longer accepting applications