Supply Chain Clinical Trial

Shawn Gehen

Delran, NJ *****

Phone: 609-***-****

www.linkedin.com/in/shawn-gehen

*******@*****.***

PROFESSIONAL EXPERIENCE

Clinical Trial Supply Chain Manager, IRT Consultant (January 2017 to present)

Client Portfolio:

oJuly 2023 to July 2024 – Agency: Tech Observer – Sponsor Company: Pfizer

oMay 2022 to June 2023 – Agency: ThermoFisher Scientific – Sponsor Company: Pfizer

oOctober 2021 to April 2022 – Agency: Lancesoft – Sponsor Company: Bristol Myers Squibb

oApril 2020 to September 2021 – Agency: PRA Health Sciences – Sponsor Company: Merck

oSeptember 2019 to December 2019 – Agency: ALKU, LLC – Sponsor Company: Tesaro (acquired by GSK)

oMay 2018 to September 2019 – Agency: Lancesoft – Sponsor Company: Janssen, division of Johnson and Johnson

oMay 2017 to April 2018 – Agency: Advanced Clinical – Sponsor Company: CSL Behring

oJanuary 2017 to April 2017 – Agency: Aerotek – Sponsor Company: Kyowa Kirin

Responsibilities:

oManaging short to long-term contracts in Clinical Trial Supply Chain Management for Investigational Medical Products and Ancillary Supplies

oCreation and implementation of ambient and cold chain inventory management plans and distribution strategies for complex Phase I through III and investigator sponsored clinical trials (IST)

oDevelopment of clinical demand forecasts based upon number of countries, number of sites per country, number of patients per site, site initiation visits per country, first patient visit, last patient visit, as well as other contributing factors

oExperienced in clinical supply chain forecasting and demand planning tools including OMP, Rapid Response, ISS Nexus, and MS Excel

oClinical Supplies Setup and maintenance in Integrated Response Technology/Integrated Web Response Systems (IRT/IWRS) including Signant Health RTSM, Suvoda, Endpoint, Prancer 4G, Almac IRT, Oracle IRT, and Perceptive

IRT Specification review and approval

UAT testing

IRT system go-live

Setup of threshold and predictive resupply values for IMP

Management of depot and clinical site inventory levels

Management of expiration dates using Do Not Ship (DNS) and Do Not Dispense (DSD) values

IMP batch loading and release by country

Temperature excursion management for ambient, cold chain, frozen and ultra frozen IMP

oCollaboration with Clinical Study Managers and teams providing supply chain updates during study team meetings

oQuote requests, approvals, forecasting, and billing using Salesforce and Ariba

oStudy forecasting using forecasting tools including OMP, Smart Supply, and MS Excel

oInventory and supply chain management using ERP’s including SAP, Oracle, JD Edwards, GPM and Global Gateway

oProficient use of eTMF (Veeva Vault):

Collaboration with Clinical Operations team in the creation of document roadmaps based on electronic data list

Uploading of clinical trial related documents for QC review

Annual quality review of eTMF study files for accuracy and inspection readiness

Participation in eTMF study audits

oExperienced with the clinical labeling process for proofing, country submission, MOH approval and label printing for IMP packaging and labeling activities

oReview and approval of master service agreements, technical agreements, and scopes of work with third party suppliers

oCoordination with Regulatory, Quality, Operations and Logistics teams for the seamless flow of clinical supply chain material and IMP

oAmbient, cold chain, and frozen supply chain management

oExperience with reading and interpreting temperature monitoring reports

oSubmission of temperature monitoring deviation reports to Quality departments or comparison to existing stability data sheets for disposition of product

oReleasing or quarantining inventory in IRT

Clinigen Group LLC (December 2014 to December 2016)

Program Manager

Responsible for maintaining client relationships throughout the managed access/compassionate use supply chain cycle for small to mid-size pharmaceutical and biotech accounts serving patients with rare diseases

Facilitation with legal and contracting teams of master service agreements, task matrixes, and scopes of work for clients entering into managed access/compassionate use programs

Research and regulatory guidance on a country-by-country basis for medicinal supply through managed access programs prior to commercial approval

Facilitation of face to face and video teleconference program kick-off meetings for managed access/compassionate use programs

Facilitation of safety management plans with drug safety and pharmacovigilance teams for managed access/compassionate use programs

Preparation and presentation of internal and external monthly key performance indicators of client deliverables

Development and execution of detailed project plans for managed access/compassionate use program implementations and closeouts

Catalent Pharma Solutions (September 1999 to December 2014)

Project Manager, Global Clinical Packaging and Distribution (7 years)

Global clinical trial supply chain management for strategic accounts

Client advocate for internal packaging and distribution activities

Facilitation of project kickoffs and delegation of assignments

Facilitation of package design,component specifications, label text and product randomization

Mapping and testing of clinical trial management systems with IWRS systems

Scheduling of packaging operations and batch record creation, review and approval

Facilitation of distribution protocols and activities

Facilitation of client meetings and conference calls

Coordinate flow of information to all internal departments and managers to ensure that customer concerns are properly communicated

Weekly, monthly and annual forecasting of revenue based upon client demand

Senior Project Coordinator—Clinical Packaging (2 years)

Coordination of clinical packaging services for pharmaceutical companies involved with clinical trials

Create estimates and quotes for clinical packaging operations

Development of clinical packaging synopses

Facilitation of component specifications, label text, randomization and package design

Schedule packaging operations, batch record review and approval, and distribution of finished goods

Facilitation of regular client meetings and conference calls

Coordination and flow of information to all internal departments and managers to ensure that customer concerns are properly communicated

Formulation of packaging instructions and bills of material in compliance with cGMP and FDA regulations

Monthly forecasting of production and billing based upon customer demand

Team member of various Lean Six Sigma Kaizen events leading to process improvement

Senior Project Coordinator—Commercial Packaging (6 years)

Work with the Pharmaceutical Sales Force in building project teams from various departments to launch new pharmaceutical products to the market

Maintain account flow of on-going accounts totaling over $12 million annually

Main point of contact for the customer on the planning, design, development, production and delivery of new and existing pharmaceutical products

Creation and maintenance of letters of quotation

Coordination of labeling change control for pharmaceutical packaging

Scheduling of production and communication of completion and ship dates of finished product to distribution

Interviewing of new prospects for Account Manager and Project Management positions

Manufacturing Cost Accounting Specialist (3 years)

Job order cost accounting in an MRP environment

Review standard costs for materials, resources, and labor rates

Review and report material, labor and overhead variances for closed jobs

Assist with month end close and perform various journal entries

Determine total cost of goods sold and net profits and report on profit and loss statements

Coordinate and manage periodic cycle counts of inventory

Perform monthly reconciliation of inter-company charges.

EDUCATION

University of Phoenix Alumni

Current Degree: Bachelor of Science in Management

Current Enrollment: Master of Business Administration

Cittone Institute (currently known as Lincoln Technical Institute)

Degree: Certification in Computerized Accounting

Accomplishments: Received President’s List Award.

Atlantic County Vocational Technical School

Course of Study: Data Processing

Degree: Certification in Data/Information Processing

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