Job Description Summary:

The Associate Director, Clinical Supplies is responsible for operational oversight of the forecasting, planning, packaging, labeling, distribution, reconciliation, and destruction of Clinical Trial Materials (CTM) and any additional study medication/products to support PTC global clinical trials and serves as the Lead Clinical Supplies team member.

He/she is responsible for oversight and management of PTC clinical supply distribution and Contract Manufacturing Organizations (CMOs) and distribution providers.

The incumbent works closely and collaborates with PTC internal departments, third party vendors (including but not limited to: Contract Manufacturing Organizations (CMOs), Contract Research Organizations (CROs) and shipping agents) and clinical study site representatives to ensure the availability of CTM at study sites globally.

The Associate Director, Clinical Supplies, ensures operations and activities are executed in accordance with all internal Standard Operating Procedures (SOPs) and in accordance with all local, county, state, and federal laws and regulations including current Good Manufacturing Practice (cGMP) regulations, GCP, FDA and International Conference on Harmonisation (ICH) guidelines.

The incumbent works cross-functionally with internal departments and external resources on Clinical Supply related issues.

Job Description:

ESSENTIAL FUNCTIONS

Primary duties/responsibilities:

Clinical Supplies Planning

• Ability to read, interpret, and provide feedback on clinical protocols.
• Engages in cross-functional planning at the program level, providing leadership on clinical supplies matters to ensure alignment across teams.
• Ability to use the Protocol along with projected and real time data to create and manage a forecast demand for a given clinical trial and at the program level.
• Leading the design of the packaging for the Clinical Trial.
• Develop and manage the label text and proof generation process including the development of the Master English Label Text and working with a vendor to provide translations and regulatory information for the countries participating in the clinical trial.
• Ensure primary and/or secondary packaging and labeling designs are maintained in accordance with product stability, clinical study dosing/dispensing, and local regulatory requirements.
• Schedules and implements labeling, packaging and quality release operations with CMOs and internally with the Quality department to ensure continuous clinical supply.
• Assist in the development of the clinical trial Pharmacy Manual.
• Prepare CTM-related information presented at investigator meetings and ensure it is accurate, clear and compliant.
• Ensures consistency across the program for presentation of investigational product, as applicable.
• Define, test, and approve Interactive Voice Response/Interactive Web Resources (IVR/IWR) system specifications and user requirements for tracking inventory, allocation, distribution, use by-date management, destruction activities, reports, and alerts.
• Accountable for ensuring the CTM-related information presented at investigator meetings is accurate, clear, and compliant.

Financial Management

• Identify vendors/resources, create Request for Quote (RFQ), and lead negotiation of pricing and processing of the legal documents required to engage the vendor's services.
• Create, maintain, and monitor the clinical program budget.
• Work with Finance if changes are required to the budget.
• Work with Procurement to generate purchase orders/requisitions.
• Responsible for the review of monthly invoices from vendors and aid accounts payable when an invoice is received.

Project Management

• Manage the development of timelines for production release and distribution of clinical trial material.
• Ability to influence other departments and vendors without direct management to ensure the clinical trial timeline is achieved.
• Recognize potential study risks in advance and provide risk mitigation options.
• Maintain "audit-ready" state ensuring investigational medicinal product (IMP) regulatory documentation is ALCOA+ and archived in the appropriate document repository.
• Provide a monthly status report on assigned clinical trials to upper management.
• Coordinate with internal and external stakeholders to achieve the clinical trial timeline.
• Participates in clinical study team meetings; advises the study team on the optimal supply strategy, aligns with study details and collaborates in achieving study objectives by providing supporting information to the study teams as required and communicates and discusses clinical trial supply timelines, cost and risk limitations.
• Ensures receipt, documentation and resolution of product complaints and incidents from investigator sites.

Inventory Management

• Monitor IMP inventory levels at regular intervals.
• For expired supply; determine if the use-by date should be extended or request destruction where applicable.
• Compare IRT inventory periodically to vendor inventory to ensure accuracy, if applicable.
• Compare current inventory to projected consumption rate to assess the health of the IMP and to determine if/when additional campaigns will be required.
• Work with vendors regarding the return, accountability, and destruction of IMP.
• Responsible for adjudication of temperature excursions that occur at the Contract Distribution and Manufacturing Organization (CDMO), clinical site facilities, and while IMP is in transit to the clinical site.

Distribution

• Define finished good IMP supply chain utilizing Distrbution Depots where required.
• Monitor to ensure IMP shipments are being dispatched and received in a timely manner.
• Ensure both clinical sites and Depots are performing IRT transactions where applicable.
• Schedule and monitor QP release within the UK and EU and work with QP to ensure the Product Specification File (PSF) is up to date and contains all the necessary documentation required to release the IMP.

Process Improvement

• Identifies and drives process improvement initiatives, taking ownership of implementation and outcomes.

People

• Manages workload allocation for junior staff supporting assigned clinical supply activities across protocols and programs.
• Acts as a coach and mentor to staff members across the team.
• Can participate in interviews and hiring staff.
• Leads by example to encourage others to prioritize personal and professional development.
• undefinedPerform other tasks and assignments as needed and specified by management.undefined

KNOWLEDGE/SKILLS/ABILITIES REQUIRED

* Minimum level of education and years of relevant work experience.

• Bachelor's degree and a minimum of 8 years of relevant clinical drug supplies experience in a pharmaceutical, biotechnology, contract research organization (CRO), university medical center or related environment or Master's degree with 6 years of relevant clinical drug supplies experience.

* Special knowledge or skills needed and/or licenses or certificates required.

• Hands-on experience supporting and understanding GMP, Good Clinical Practice (GCP), and ICH guidelines as related to CTM labeling, packaging and distribution operations and the overall drug development process.
• Hands-on experience supporting clinical supply chain for clinical trials.
• IRT (IVRS and/or IWRS) experience
• Proficiency with Microsoft Office (including MS Project).
• Excellent verbal and written communication and skills.
• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
• Experience shipping clinical supplies to domestic or international locations including knowledge of the shipping documentation required for both.

* Travel requirements

• 10-20%

Expected Base Salary Range: $165,500 - $194,700. The base salary offered will be contingent on assessment of candidate education level, background, and experience relative to the requirements of the position they are being considered for, as well as review of internal equity.

In addition to base salary, PTC employees are also eligible for short- and long-term incentives. All eligible employees may also enroll in PTC's medical, dental, vision, and retirement savings plans.

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