Position: Clinical/Commercial Supply Chain (Manager - Senior Manager)

Position Summary

Karuna is seeking an experienced and motivated Manager – Senior Manager, Clinical/Commercial Supply Chain to join our rapidly-growing organization. Reporting to the Associate Director, Supply Chain Logistics, this critical position will interface with a diverse team across Clinical Development, Regulatory, Manufacturing, Quality and external partners to support clinical packaging, labeling inventory and distribution support of clinical material for multiple clinical trials and our potential commercial operations. We are looking for a professional who has extensive experience in the biotech/pharmaceutical industry, and who has specific experience in clinical trial material management, IRT, and logistics activities related to import/export, licenses, tariffs, insurance, and importer of record services for clinical trial support. This position will also support any commercial operations as needed.

Responsibilities

• Interact with internal and global external customers and suppliers in order to accomplish project objectives, including packaging, labeling, shipment, inventory management, and drug return logistical activities.
• Establish specifications, UAT, and maintain and operate multiple IRT software platforms.
• Prepare and review Global Trade related shipping paperwork such as FDA End Use Letters, Prototype Exemptions, Customs Invoices, USDA Statements, TCSA Statements, and Permits.
• Establish, update and maintain policies and procedures required to maintain good manufacturing practices (GMP) and good distribution practices (GDP) compliance in the storage, distribution and returns of clinical product.
• Maintain close partnerships with Quality Assurance, contract manufacturers, and couriers.
• Analyze shipment temperature data & manage temperature excursions during storage and transportation.
• Support country logistics for shipping and importation on assigned study or program.
• Monitor inventory levels and provide feedback to CMC Directors, Program leads and their direct Managers regarding expiry and re-supply needs across inventory.
• Participate in clinical supply group's system enhancement initiatives as assigned and needed.
• Monitor regularly drug expiry and the appropriate inventory levels across assigned clinical programs.
• Work actively and align with Clinical Operation/Study team to help create forecast for assigned study and program including enrollment rate.
• Support and oversight of packaging requirements for programs and/or protocols assigned.
• In conjunction with study trial managers, monitor enrollment, drop-out rates and actual supply need on assigned protocols and/or programs. Ensure continuous re-assessment of project needs on assigned programs and/or protocols.
• Lead/assist in label creation and approvals process, including translations for all countries, on assigned study and/or program.
• Support return and destruction of IMPs from sites to depots for assigned study.
• Interface with other members of the Clinical Supply Chain to provide and obtain information and to ensure on-time delivery of finished goods to depot.
• Perform inventory checks and manage inventory levels and cycle count at the vendor yearly on assigned study.
• Oversee and provide input to distribution plans executed by 3rd party Contract Research Organizations.
• Manage and maintain IMP distribution and return drug plans and manage Clinical Supply documentation associated with assigned program, in compliance with GMP and industry standards.
• Provide support to Commercial Operations as needed.

Required Qualifications

• BS in a scientific field.
• APICS CSCP certification is a plus.
• Minimum 2+ years of relevant experience.
• Proven experience with inventory management and distribution, including cold chain, import/export and reverse logistics.
• Experience in clinical supply logistics. Experience in drug substance & drug product logistics is a plus.
• Experience in commercial operations is a plus
• Experience with forecasting methods and software a plus.
• Experience and strong understanding of cGMP and/or cGCP and Pharmaceutical Development.
• Must possess exceptional communication skills, self-motivated, exposure and/or knowledge of software programs including Microsoft Project, Teams, Power Point, MS Project, Interactive Response Technology (IRT), and Microsoft Office.
• Willingness to learn and sense of urgency to meet patient and program needs.
• Knowledge of clinical import/export regulations, including pro-forma invoice generation, import regulations, global trade compliance, and QP requirements.
• Experience in working with third-party CRO and CMO clinical supply operations.
• Excellent verbal and written skills, allowing for an open and effective dialogue throughout the company.
• Attention to detail and quality are critical to success.
• Highly accountable for the results and outcomes of their responsibilities and understands the impact of their efforts, results, and attitudes on others.
• Uses teamwork to work cooperatively toward the most effective solutions, championing the best ideas of team members, and assisting where help is needed yet is capable of highly independent work when efficiency is required.
• Results-oriented individual who is highly motivated, decisive, flexible in thought, and has the creativity to excel in and contribute to a rapidly growing company.
• Forward thinking mindset with the ability to manage multiple projects, and identify and resolve issues.
• Broad experience in an emerging, publicly traded company environment is a plus.

The successful candidate will also embody our values:

Our purpose is to create value for those we have the privilege to serve:

• We take pride in our work
• We keep our promises and deliver
• We are driven to meaningfully innovate
• We succeed through inclusion and teamwork

Karuna Therapeutics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Karuna Therapeutics requires all employees be fully vaccinated by an approved vaccine against COVID-19, including a booster dose if it has been more than eight months since the employee's original vaccination, unless you need an exemption due to disability, pregnancy or conditions related to pregnancy or religion or unless otherwise provided by law; in the case of exemption, weekly testing will be required.