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Purpose:
Associate Director, Clinical and QC Supply Management is accountable for on time delivery of all clinical trial (CT) materials (inclusive of investigational product, commercial materials for clinical trials and various ancillary supplies) and QC samples (QC sample, cell, reference standard etc) in China in partnership with global Product Delivery, CMC teams and local clinical development, regulatory teams, external partners in accordance with Lilly SOPs, processes, procedures and local laws and regulations.
Associate Director, Clinical and QC Supply Management needs well demonstrated strong knowledge of local import/export policies and requirements, strong leadership and influence skills to interact with local customers, vendors, internal functions to proactively lead solutions for complex shipment issues/hurdles of various CT material and QC sample supplies identified.
Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.
1.Leadership
a. Lead robust strategies of China CT materials and accountable for on time delivery for clinical trial development which can include local clinical trials, regional participation in global trials, investigator initiated research, and expanded access programs etc.
b .Accountable for systematic QC sample shipment success to China.
c. Demonstrated strong leadership and influence skills to interact with local customers, vendors, internal functions to proactively lead solutions for complex shipment issues/hurdles of various supplies identified.
d. Lead team to proactively identify and communicate with Product Delivery, CMC, Clinical Development and the affiliate about the potential risks, limitations and mitigation/contingency strategies and solutions associated with the CT material supply and QC sample shipment.
e. Build strong relationships with internal and external partner leaders to ensure robust communication with them as it relates to supply and shipment of CT materials and QC samples in China.
f. Continuously grow team’s strong technical expertise of import/export, communication skills with internal/external partners, proactive problem solving skills and optimizing related processes.
2.Technical Expertise
a. Strong technical expert in local laws and regulations and import/export policies and requirements for CT materials and QC samples.
b. Ensure Import/Export and shipment strategies of China CT materials/QC samples systematically compliant with GMP & GCP guidelines. Lilly compliance, processes and local principles.
c. Demonstrate strong capabilities and good influence skills with China various customers.
d. Familiar with commercial product sourcing strategies and processes for managing.
e. Serve as solo person to provide local import/export policies, guidance for global PRD and CMC teams.
3.Delivery
a. Oversight of the documentation preparation from team to support importation, exportation, quality release of CT material and QC sample, as well as distribution activities of CT materials, if needed
b. Ensure team’s compliance with appropriate Lilly procedures, local regulatory requirements, and local laws in their region as it relates to CT materials and QC samples.
c. Lead team systematically share learning related to CT material shipment, delivery and QC sample import/export, and shipment.
d. Accountable for appropriate escalation of shipment issues and potential countermeasures to global and local leadership.
4.Continuous Improvement
a. Lead systematic performance metrics related to CT material and QC sample shipment and identify areas for improvement and simplification.
b. Ensure global SOPs and processes for CT materials supply and QC sample shipment to maintain alignment with local laws and regulations
c. Influence the quality system at affiliate level to meet regulatory expectation and business needs.
d. Lead team continuously optimize local processes relates to CT materials supply/QC samples shipment including the creation and update of procedures, tools, reference documents and process maps for inefficiencies and improvement opportunities, identify action plans, and implement improvements.
e. Communicate process improvements, industry trends, new technologies, and new capabilities to global and local leadership and key stakeholders.
Minimum Qualification Requirements:
At least bachelor’s degree
Strong knowledge and experience of local import/export policies and requirement of CT materials and QC samples.
Experience (7+ years) managing clinical trial materials, various complex supply chains, and/or cross-functional projects.
Demonstrated leadership to resolve complex various customer clearance issues
More than 10 years of pharmaceutical development experience
Experience managing various complex supply chains.
Experience working and communicating with vendors and customers.
Fluent spoken and written English skills.
Other Information/Additional Preferences:
Advanced degree (Master, Doctorate, etc.) in operations management and various supply chains
Degree, certification, or equivalent experience in project or supply chain management (i.e. APICS).
Demonstrated ability to build and foster teamwork.
Excellent interpersonal and organizational skills.
Ability to influence at many levels and across disciplines, both internally and externally.
Ability to manage multiple tasks and respond to changing priorities.
High initiative, learning agility and a flexible, positive attitude.
Strong quantitative skills and expertise.
High degree of accuracy and attentive to details.
Ability to proactively identify problems and work toward a solution.
Demonstrated leadership and broad expertise within the clinical trial material services organization.
Ability for international travel to support development and integration with global partners (up to 10%).
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