Associate Director, Clinical Supplies

Travere Therapeutics; Denver (CO); On-site; USD 150,000 - 195,000; Full time

Benefits offered by this job

Health benefits

Retirement plans with employer match

Generous paid time off

Life insurance

Disability insurance

Job summary

Travere Therapeutics, based in San Diego, seeks an Associate Director, Clinical Supplies to lead IP supply for global clinical trials in line with GxP requirements.

Collaborate with Clinical Operations, Quality Assurance, Regulatory Affairs, and external vendors to forecast, package, label, and distribute IP across all phases, while shaping budgets and timelines.

Qualifications

• Bachelor's degree or equivalent in biomedical, life science, supply chain, or related field.
• 8+ years of clinical supply chain experience within biotech, pharma, or CROs.
• Experience supporting global Phase I–IV clinical trials.
• Experience managing external vendors including CMOs, depots, and IRT providers.

Responsibilities

• Lead CMOs, depots, and vendors for packaging, labeling, distribution, and inventory of investigational products across all phases.
• Partner with cross-functional teams to develop accurate clinical supply forecasts, budgets, and study timelines.
• Contribute to protocol development focusing on IP preparation, administration, and supply feasibility.
• Author and maintain Pharmacy Manuals and IP Handling Manuals.
• Train clinical sites and vendors on IP handling, storage, accountability, and returns/destruction.

Skills

Cross-functional teamwork

Vendor management

Project management

GCP/GMP/ICH knowledge

Communication skills

Risk management

Education

Bachelor's degree

Tools

IRT platforms

SmartSheets

Excel

MS Word

PowerPoint

Job description

Department: 106600 Clinical Operations

Location: San Diego, USA- Remote

Be a part of a global team that is inspired to make a difference in the lives of people living with rare disease.

At Travere Therapeutics, we recognize that our exceptional employees are vital to our success. We are a dedicated team focused on meeting the unique needs of rare patients.Our work is rewarding - both professionally and personally - because we are making a difference. We are passionate about what we do.

We are seeking talented individuals who will thrive in our collaborative, diverse, fast-paced environment and share in our mission - to identify, develop and deliver life-changing therapies to people living with rare disease. We stick by our values centered on patients, courage, community, and collaboration to pursue our vision of becoming a leading biopharmaceutical company dedicated to the delivery of innovation and hope to patients in the global rare disease community.

At Travere Therapeutics, we are in rare for life. We continue to courageously forge new paths as we move toward a common goal of elevating science and service for rare patients.

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 Therapeutics, Inc. is an EEO/AA/Veteran/Disability Employer.

If you require a reasonable accommodation to complete the application or interview process, please contact us by sending an email to [e-mail]. Please note that this email address is to be used exclusively to request an accommodation with the online application, interview or hiring process only. Travere HR will not reply to emails sent to this address for any other reason.