Associate Director, Clinical Supplies Project Manager

About the role

The Role Associate Director, Clinical Supplies Project Management is responsible for overseeing and leading clinical supply activities for a program and/or a clinical study. The scope includes operational planning and strategy for end-to-end supply management, including demand planning, label development, packaging/labeling, distribution, IRT UAT/supply management, temperature excursions, and site activations.

Responsibilities

• Assists in identifying resources required to manage programs and their associated clinical studies.
• Provides leadership to more junior colleagues by supporting their development through coaching and identifying key opportunities for development.
• Accountable for planning, strategies, and budget management for programs.
• Drives best practice for supply logistics and processes surrounding clinical supplies.
• Oversees process for inventory control and distribution activities including scheduling, issue resolution, change implementation, vendor oversight, and scope review related to clinical supplies.
• Responsible for logistics as required to support the labeling, packaging, and shipment of clinical drug supplies to depots/investigative sites as well as other clinical supplies as necessary.
• Contributes to business review meetings with third-party drug supply vendors.
• Responsible for contributing to the development of IRT requirements, user acceptance testing, and supply management after IRT go-live.
• Responsible for Clinical Supplies Planning and Forecasting as required to meet program objectives.
• Develops and compiles KPIs.
• Develops drug and clinical supply training materials for investigational sites.

Requirements

• At least 8 years of clinical supply management experience in a clinical research environment.
• Bachelor’s degree in a science-based subject (advanced degree preferred).
• Prior Cold Chain distribution experience required.
• IIR implementation, design, and management experience required.
• Prior Biopharmaceutical, pharmaceutical or chemical manufacturing experience preferred.
• Creative, capable problem-solver.
• Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines and demonstrated understanding of clinical research protocol requirements.
• Demonstrated proficiency with word processing, spreadsheet, database, presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, and SharePoint).

Qualifications

• Curious in exploring new paths for clinical research.
• Bold in proposing creative solutions and ideas.
• Works collaboratively with multifunctional teams and partners.
• Relentless in pursuing successful outcomes.

Pay & Benefits

At Moderna, we believe that when you feel your best, you can do your best work. That’s why our US benefits and global well-being resources are designed to support you—at work, at home, and everywhere in between. Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs. A holistic approach to well-being, with access to fitness, mindfulness, and mental health support. Family planning benefits, including fertility, adoption, and surrogacy support. Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown. Savings and investment opportunities to help you plan for the future. Location-specific perks and extras.

Schedule

The salary range for this role is $142,500.00 - $256,500.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual’s position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs.

Benefits

• Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs.
• A holistic approach to well-being, with access to fitness, mindfulness, and mental health support.
• Family planning benefits, including fertility, adoption, and surrogacy support.
• Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown.
• Savings and investment opportunities to help you plan for the future.
• Location-specific perks and extras.