Department:
106600 Clinical Operations

Location:
San Diego, USA- Remote

Position Summary:

The Associate Director, Clinical Supplies is responsible for leading the operational management of investigational product (IP) supply activities in accordance with GxP requirements. This role partners closely with Clinical Operations, Technical Operations, Quality Assurance, Regulatory Affairs, Clinical Pharmacology, and external vendors to ensure timely packaging, labeling, distribution, accountability, and forecasting of investigational product across global clinical trials. The Associate Director contributes to clinical supply strategy, manages outsourced vendors, and supports study teams throughout protocol development and supply planning.

Responsibilities:

• Lead CMOs, depots, and clinical supply vendors responsible for packaging, labeling, distribution, and inventory management of investigational products across all phases of clinical development.
• Partner with cross-functional teams to develop accurate clinical supply forecasts, budgets, and study timelines.
• Contribute to protocol development with emphasis on investigational product preparation, administration, and supply feasibility.
• Author and maintain Pharmacy Manuals and Investigational Product Handling Manuals.
• Ensure training of clinical sites and vendors on investigational product handling, storage, accountability, and return/destruction procedures.
• Lead implementation, User Acceptance Testing (UAT), maintenance, and troubleshooting of IRT systems with external partners.
• Provide expertise in global clinical supply chains, including temperature-controlled products and international logistics.
• Support compliance with global import/export regulations governing investigational products.
• Monitor vendor performance through governance meetings and KPI reviews.
• Manage purchase orders, vendor invoices, and study supply budgets.
• Identify supply chain risks and implement mitigation strategies.
• Mentor junior staff and contribute to SOP development and continuous process improvement.
• Additional duties assigned as needed.

Education/Experience Requirements:

• Bachelor's degree, or equivalent, in a biomedical, life science, supply chain, or related field required. Equivalent combinations of education and experience may be considered.
• 8+ years of clinical supply chain experience within biotechnology, pharmaceutical, or CRO settings required.
• Experience supporting global Phase I-IV clinical trials.
• Experience managing external vendors, including CMOs, depots, and IRT providers.

Additional Skills/Experience:

• The ideal candidate will embody Travere's core values: Courage, Community Spirit, Patient Focus and Teamwork.
• Driven, intelligent, passionate about making a difference for patients with rare diseases.
• Working knowledge of GCP, GMP, ICH guidelines, FDA regulations, and global clinical supply requirements.
• Experience with Interactive Response Technology (IRT) platforms.
• Strong project management, vendor management, and cross-functional collaboration skills.
• Excellent written and verbal communication skills.
• Strong analytical, organizational, and problem-solving abilities with a proactive approach to risk management.
• Ability to mentor team members and influence without direct authority.
• Proficiency in Microsoft Word, Excel, PowerPoint and SmartSheets.
• Ability to travel 20% domestically and internationally.
• All positions have an essential job function to be able to perform face to face work with colleagues and/or onsite in San Diego. No role is expected to be 100% remote.

Total Rewards Offerings:
Travere provides comprehensive total rewards offerings that demonstrate our commitment as a diverse, equitable, people-centric, and pay-for-performance organization.

Benefits: Our benefits include premium health, financial, work-life and well-being offerings for eligible employees and dependents, wellness and employee support programs, life insurance, disability, retirement plans with employer match and generous paid time off.

Compensation: Our competitive compensation package includes a combination of both cash compensation (base pay and short-term incentive) and long-term incentive compensation (company stock), designed to recognize, retain, and reward employees.

Target Base Pay Range:
$150,000.00 - $195,000.00

*This information is current as of the date of this posting and may be modified in the future. Actual pay offered to a candidate will depend on a variety of factors including the candidate's experience, education, skills, and location.

Travere will accept applications on an ongoing basis until a candidate is selected for the position.