Associate Director / Director, Clinical Drug Supply & Logistics

Kalaris Therapeutics; Berkeley Heights (NJ); Hybrid; USD 185,000 - 240,000; Full time

Job summary

Kalaris Therapeutics, Inc. is seeking a Director of Clinical Drug Supply & Logistics to lead end-to-end supply chain for multiple clinical programs. You will oversee packaging, labeling, distribution, and IP logistics while ensuring GMP/GCP compliance and audit readiness.

The role is hybrid, requiring coordination with global vendors, internal teams, and external sites. Travel 25% is expected, including on-site activities in Berkeley Heights, NJ.

Qualifications

• Bachelor’s degree in Science or related field and 8+ years of clinical supply chain experience.
• Strong knowledge of GMP, GCP, GDP, ICH and 21 CFR Part 11.
• Proven project management, vendor oversight, and budget forecasting skills.

Responsibilities

• Lead clinical program supply planning and demand forecasting.
• Oversee IP inventory, packaging, labeling, distribution, returns and destruction.
• Ensure GMP/GCP/GDP compliance and regulatory readiness across activities.
• Coordinate with QA, CMC, Clinical Ops and external vendors on supply strategy.

Skills

GxP knowledge

IRT system design

Vendor oversight

Budget forecasting

Cross-functional leadership

Communication skills

Education

Bachelor’s degree in Science or related field

Tools

Excel

Job description

Kalaris Therapeutics is a clinical stage biopharmaceutical company dedicated to the development and commercialization of treatments for prevalent retinal diseases with major unmet medical needs.

Kalaris’ lead asset, TH103, was developed by Lasker Award winner, Dr. Napoleone Ferrara, a pioneer in the field of VEGF research, and the inventor of Lucentis and Avastin during his time at Genentech. TH103 is a novel, clinical stage anti-vascular endothelial growth factor (VEGF) drug, specifically engineered to achieve extended intraocular retention with enhanced VEGF inhibition in patients with exudative and/or neovascular retinal diseases.

In head-to-head preclinical studies, TH103 showed more anti-VEGF activity and longer duration of activity compared to aflibercept, the current market-leading anti-VEGF agent. In a Phase 1a single ascending dose trial, TH103 was generally well tolerated and showed a potent anti-VEGF effect on functional and anatomical outcomes at 1-month post-dosing. Single dose durability signals, including pharmacokinetic analysis and retreatment results, suggest that TH103 may offer extended treatment durability outcomes after a standard four-dose loading regimen. Kalaris is currently enrolling a Phase 1b/2 Multiple Ascending Dose trial of TH103 in patients with nAMD, to help assess the safety and efficacy of repeat TH103 administration and to inform dose selection for potential Phase 3 development.

Kalaris’ board of directors, management team and investors include co-founders, scientists and leaders and investors from companies that have played pivotal roles in developing retina therapeutics.

About nAMD

nAMD is a leading cause of blindness in the United States and Europe that affected an estimated 1.6 million adults in the United States in 2024. Over the past 20 years, anti-VEGF therapeutics have revolutionized the treatment of prevalent exudative and/or neovascular retinal diseases, which represented an estimated $15 billion global branded market in 2024. While clinical trials for these drugs have shown improvements in mean visual acuity, these results often are not reproduced in real-world settings. Many patients find the treatment burden to be challenging because it requires a demanding schedule of clinic visits and years of monitoring and treatments. This onerous treatment burden can lead to a lack of adherence to the frequent visit regimen and a decline in vision after initial gains.

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The Director, Clinical Drug Supply & Logistics leads the end-to-end strategy and operational execution of clinical trial material (CTM) and ancillary supply chains across one or more clinical programs. This role ensures the timely packaging, labeling, distribution, return, and destruction of investigational products (IP) in compliance with applicable global GxP requirements.

The Director serves as the central liaison across CMC, Clinical Operations, Quality Assurance, and external vendors to align supply strategy with enrollment forecasts, maintain uninterrupted study support, and ensure inspection readiness of IP-related Trial Master File (TMF) documentation. The role also provides financial and vendor oversight to support efficient, high-quality execution.

Job Description and Specific Responsibilities

Clinical Supply Strategy & Planning

• Lead supply planning for clinical programs and studies, including demand forecasting aligned with enrollment projections and the overall clinical development plan.
• Establish and manage timelines for IP packaging, labeling, release, distribution, returns, and destruction.
• Develop and adjust resupply strategies based on enrollment, stability data, shelf life, and study requirements.
• Author, review, and/or approve applicable clinical and technical documents, including clinical label text, packaging batch records, clinical trial protocols, pharmacy manuals, investigational medicinal product dossiers (IMPDs), randomization specifications, and master kit lists.
• Develop and maintain accurate budget forecasts for clinical supply activities.

Inventory & Distribution Management

• Oversee IP inventory strategy and real-time inventory tracking; proactively identify and mitigate supply risks and potential shortages.
• Ensure compliant and timely shipment of IP to global clinical study sites, including temperature-controlled distribution where required.
• Develop and oversee IP accountability, returns, reconciliation, and destruction strategies.
• Develop and oversee regional depot setup, importation, and distribution strategies with external vendors.
• Collaborate with Quality Assurance and qualified partners to coordinate Qualified Person (QP) certification and release requirements for the EU, UK, Israel, and other applicable jurisdictions.
• Manage sourcing, packaging, labeling, and supply strategies for ancillary materials and comparator products.

IRT Oversight

• Lead Interactive Response Technology (IRT) supply strategy, system design, configuration, and User Acceptance Testing (UAT).
• Partner with cross-functional teams and IRT vendors to develop specifications and ensure system functionality aligns with protocol design, randomization, inventory, and resupply needs.
• Monitor and manage clinical supply activities through IRT from study start-up through closeout, including changes and issue resolution.
• Lead vendor selection, contracting, and oversight of IP service providers, including packaging, labeling, distribution, depots, and IRT, in collaboration with CMC and other functions.
• Develop requests for proposals (RFPs), review proposals, negotiate statements of work (SOWs), and contribute to contract and change-order reviews.
• Manage vendor performance, deliverables, timelines, and budgets, including invoice review, cost tracking, and reconciliation.
• Serve as the escalation point for IP supply and vendor-related issues; develop and implement appropriate corrective actions and risk mitigation plans.

Compliance & Inspection Readiness

• Ensure supply activities comply with applicable GMP, GCP, GDP, ICH guidelines, regulatory requirements, and company procedures.
• Support regulatory inspections and internal audits; represent Clinical Drug Supply & Logistics as appropriate.
• Maintain inspection-ready IP-related TMF records and appropriate documentation standards.
• Participate in the development and maintenance of relevant SOPs, working practices, templates, and clinical supply plans.

Cross-Functional Leadership

• Serve as the primary escalation point for IP-related issues, including temperature excursions, product complaints, and supply interruptions, coordinating assessment and resolution with appropriate functions.
• Communicate clearly and proactively with clinical study teams, internal stakeholders, sites, CROs, and external vendors.
• Foster a collaborative, solutions-oriented environment and support timely cross-functional decisions.

Qualifications/Experience

• Bachelor’s degree in Science, Healthcare, Supply Chain Management, or a related discipline, with 8+ years of clinical supply chain experience in the pharmaceutical or biotechnology industry.
• Strong knowledge of GxP requirements (GMP, GCP, GDP), ICH guidelines, and 21 CFR Part 11.
• Demonstrated experience with IRT system design, supply configuration, and User Acceptance Testing (UAT).
• Understanding of pharmaceutical stability programs, product shelf life, and expiry management.
• Proven project management, vendor oversight, financial management, and budget forecasting skills.
• Strong negotiation, problem-solving, independent decision-making, and supply risk mitigation capabilities.
• Excellent written and verbal communication skills, including the ability to influence cross-functional stakeholders and external partners.
• Highly organized, detail-oriented, and capable of managing multiple concurrent clinical programs.
• Proficiency in Microsoft Office, with advanced Excel skills preferred.

This role is hybrid and will require periodic travel to clinical vendors, CRO meetings, investigator meetings, or other business-related activities. This role also requires multiple overnight days of monthly travel to on-site meetings in Berkeley Heights, NJ for clinical team and company meetings. The travel time is expected to be approximately 25% of the total working hours.

The salary range for this position is $185,000 USD to $240,000 USD annually. This salary range is an estimate, and the actual salary may vary based on the Company’s compensation practices.

In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and complete the required employment eligibility verification form upon hire.