Associate Director, Global Supply Chain (CMC)

Tyra Biosciences Inc.; United States; Remoto; USD 189.000 - 205.000; Tempo pieno

Vantaggi offerti da questo lavoro

Competitive base salary

Bonus and equity packages

Employer-paid medical/dental/vision

401(k) with company match

Employee Stock Purchase Plan

Descrizione del lavoro

Tyra Biosciences Inc. is seeking an Associate Director, Global Supply Chain to lead the development and execution of global clinical supply strategies from early trials to pivotal studies.

You will own demand planning, supply strategy, packaging, labeling, distribution, and inventory management while partnering with CMC, Regulatory, and external providers to ensure uninterrupted, compliant supply for global trials.

Competenze

• Bachelor’s degree in Supply Chain Operations, Business, Engineering, Life Sciences, Pharmacy, or related field required.
• Advanced degree preferred.
• Minimum 8 years of relevant experience in pharmaceutical, biotechnology, or clinical supply operations.
• Demonstrated experience leading global clinical supply activities for complex clinical studies and development programs.
• Strong expertise in clinical demand forecasting, inventory planning, supply strategy development, and risk management.
• Hands‑on experience with IRT systems including design, implementation, testing, and study maintenance.
• Experience managing CMOs, clinical depots, logistics providers, packaging vendors, and other external service providers.
• Strong understanding of global clinical packaging, labeling, distribution, logistics, inventory management, and reconciliation activities.
• Working knowledge of global import/export requirements and customs regulations supporting clinical trials.
• Strong understanding of GxP quality systems and applicable regulatory requirements.
• Working knowledge of drug substance, drug product, stability, packaging, and other CMC activities that impact clinical supply strategy.
• Experience supporting regulatory filings, audits, inspections, and health authority interactions preferred.
• Pharmaceutical development experience across multiple regions and multiple concurrent studies preferred.
• Excellent organizational skills and an ability to prioritize effectively to deliver results within established timelines.
• Ability to work independently and as part of a team.
• Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment.
• Candidates must be authorized to work in the U.S.
• Must be able to travel (domestic and international) up to 10%.

Mansioni

• Lead development and execution of global clinical supply strategies for assigned clinical programs and studies.
• Translate clinical protocols, enrollment assumptions, country activation plans, dosing regimens, and development timelines into comprehensive demand forecasts and supply plans.
• Develop supply scenarios and risk assessments to support decision-making related to enrollment variability, cohort expansion, formulation changes, manufacturing capacity, inventory levels, and expiry management.
• Establish inventory, safety stock, resupply, and allocation strategies to ensure uninterrupted patient supply while minimizing waste and cost.
• Evaluate supply implications associated with protocol amendments, country additions, enrollment changes, manufacturing delays, and regulatory requirements.
• Support long-range planning activities by communicating clinical demand forecasts and supply requirements to CMC, manufacturing, and finance stakeholders.
• Present supply risks, assumptions, mitigation plans, and recommendations to cross-functional program teams and senior leadership.
• Serve as the clinical supply lead and primary point of accountability for assigned clinical studies and development programs.
• Ensure clinical supply readiness for study startup, cohort initiations, country activations, interim study milestones, and study closeout activities.
• Lead oversight of global packaging, labeling, storage, distribution, returns, reconciliation, destruction, and transportation activities.
• Develop packaging and labeling strategies appropriate for study design, blinding requirements, country-specific regulations, and operational efficiency.
• Oversee global inventory deployment and replenishment activities across depots, clinical sites, and direct-to-patient supply channels where applicable.
• Monitor inventory levels, expiry timelines, shipment performance, and supply metrics to ensure continuity of supply throughout the clinical trial lifecycle.
• Lead management of temperature excursions, shipment deviations, inventory discrepancies, and supply interruptions.
• Lead the clinical supply workstream for IRT strategy, system design, implementation, testing, deployment, maintenance, and study closeout.
• Collaborate with Clinical Operations, Data Management, Biostatistics, and external vendors to ensure successful system implementation and performance.
• Monitor supply system performance and inventory data to proactively identify risks and optimize clinical supply strategies.
• Support implementation and continuous improvement of forecasting, inventory management, and supply planning systems.
• Ensure all clinical supply activities comply with applicable GxP requirements, internal procedures, quality agreements, and regulatory requirements.
• Partner with Quality Assurance to investigate deviations, determine root causes, assess impact, and implement corrective and preventive actions.
• Support inspection readiness and audit activities related to clinical supply operations.
• Author, review, approve, and maintain SOPs, work instructions, supply plans, specifications, and other clinical supply documentation.
• Provide subject matter expertise and operational support for regulatory submissions, health authority information requests, and clinical trial applications.
• Oversee import/export readiness and ensure required permits, licenses, documentation, and customs requirements are maintained to support global trial execution.

Conoscenze

Supply chain leadership

Forecasting

Inventory planning

Supply risk management

IRT systems

CMO management

Regulatory compliance

Cross-functional collaboration

Formazione

Bachelor’s degree in related field

Advanced degree preferred

Strumenti

IRT systems

ERP / Inventory software

Descrizione del lavoro

ABOUT THE JOB

POSITION OVERVIEW

The Associate Director, Global Supply Chain is responsible for the development and execution of global clinical supply strategies supporting clinical development programs from First-in-Human through pivotal studies. This position serves as the clinical supply lead for assigned programs and studies and provides end-to-end leadership for demand planning, supply strategy, packaging and labeling, distribution, inventory management, import/export compliance, and clinical supply risk management. Working closely with Clinical Operations, CMC, Regulatory Affairs, Quality Assurance, Finance, and external service providers, the Associate Director ensures uninterrupted, compliant, and cost-effective supply of investigational products to support global clinical trials. This role translates clinical development plans into executable supply strategies, proactively identifies and mitigates supply risks, and provides strategic recommendations to program leadership. The Associate Director will establish and maintain strong relationships with contract manufacturing organizations, clinical depots, logistics providers, packaging vendors, and IRT providers to ensure operational excellence and successful clinical trial execution.

KEY RESPONSIBILITIES

• Lead development and execution of global clinical supply strategies for assigned clinical programs and studies.
• Translate clinical protocols, enrollment assumptions, country activation plans, dosing regimens, and development timelines into comprehensive demand forecasts and supply plans.
• Develop supply scenarios and risk assessments to support decision‑making related to enrollment variability, cohort expansion, formulation changes, manufacturing capacity, inventory levels, and expiry management.
• Establish inventory, safety stock, resupply, and allocation strategies to ensure uninterrupted patient supply while minimizing waste and cost.
• Evaluate supply implications associated with protocol amendments, country additions, enrollment changes, manufacturing delays, and regulatory requirements.
• Support long‑range planning activities by communicating clinical demand forecasts and supply requirements to CMC, manufacturing, and finance stakeholders.
• Present supply risks, assumptions, mitigation plans, and recommendations to cross‑functional program teams and senior leadership.
• Serve as the clinical supply lead and primary point of accountability for assigned clinical studies and development programs.
• Ensure clinical supply readiness for study startup, cohort initiations, country activations, interim study milestones, and study closeout activities.
• Lead oversight of global packaging, labeling, storage, distribution, returns, reconciliation, destruction, and transportation activities.
• Develop packaging and labeling strategies appropriate for study design, blinding requirements, country‑specific regulations, and operational efficiency.
• Oversee global inventory deployment and replenishment activities across depots, clinical sites, and direct‑to‑patient supply channels where applicable.
• Monitor inventory levels, expiry timelines, shipment performance, and supply metrics to ensure continuity of supply throughout the clinical trial lifecycle.
• Lead management of temperature excursions, shipment deviations, inventory discrepancies, and supply interruptions.
• Lead the clinical supply workstream for IRT strategy, system design, implementation, testing, deployment, maintenance, and study closeout.
• Collaborate with Clinical Operations, Data Management, Biostatistics, and external vendors to ensure successful system implementation and performance.
• Monitor supply system performance and inventory data to proactively identify risks and optimize clinical supply strategies.
• Support implementation and continuous improvement of forecasting, inventory management, and supply planning systems.
• Ensure all clinical supply activities comply with applicable GxP requirements, internal procedures, quality agreements, and regulatory requirements.
• Partner with Quality Assurance to investigate deviations, determine root causes, assess impact, and implement corrective and preventive actions.
• Support inspection readiness and audit activities related to clinical supply operations.
• Author, review, approve, and maintain SOPs, work instructions, supply plans, specifications, and other clinical supply documentation.
• Provide subject matter expertise and operational support for regulatory submissions, health authority information requests, and clinical trial applications.
• Oversee import/export readiness and ensure required permits, licenses, documentation, and customs requirements are maintained to support global trial execution.

QUALIFICATIONS & EXPERIENCE

• Bachelor's degree in Supply Chain Operations, Business, Engineering, Life Sciences, Pharmacy, or a related field required.
• Advanced degree preferred.
• Minimum 8 years of relevant experience in pharmaceutical, biotechnology, or clinical supply operations.
• Demonstrated experience leading global clinical supply activities for complex clinical studies and development programs.
• Strong expertise in clinical demand forecasting, inventory planning, supply strategy development, and risk management.
• Hands‑on experience with IRT systems including design, implementation, testing, and study maintenance.
• Experience managing CMOs, clinical depots, logistics providers, packaging vendors, and other external service providers.
• Strong understanding of global clinical packaging, labeling, distribution, logistics, inventory management, and reconciliation activities.
• Working knowledge of global import/export requirements and customs regulations supporting clinical trials.
• Strong understanding of GxP quality systems and applicable regulatory requirements.
• Working knowledge of drug substance, drug product, stability, packaging, and other CMC activities that impact clinical supply strategy.
• Experience supporting regulatory filings, audits, inspections, and health authority interactions preferred.
• Pharmaceutical development experience across multiple regions and multiple concurrent studies preferred.
• Excellent organizational skills and an ability to prioritize effectively to deliver results within established timelines.
• Ability to work independently and as part of a team.
• Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment.
• Candidates must be authorized to work in the U.S.
• Must be able to travel (domestic and international) up to 10%.

Base Salary Range: $188,791 - $205,444 USD

Individual compensation will be determined based on factors such as work location, skills, education, training, and experience.

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What we offer US-based Employees

• Competitive base, bonus, new hire and ongoing equity packages
• The starting compensation range(s) for this role is for a full‑time employee (FTE) basis
• Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment
• Employer‑paid Medical, dental, and vision insurance
• Employer‑paid life insurance, AD&D, short‑term disability, long‑term disability, and EAP coverage
• 401(k) Plan with a fully vested company match 1:1 up to 4% of contributions
• Employee Stock Purchase Plan
• 14 -18 paid holidays, including office closure between December 25th and January 1st
• Flexible vacation
• Sick time
• Fitness Program
• Get Outdoors Program
• Paid parental leave benefit
• Tuition assistance

Equal Opportunity Employer

Tyra Biosciences is an equal opportunity employer committed to building a diverse and inclusive workforce. Employment decisions are made without regard to race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information, gender identity or expression, veteran status, or any other characteristic protected by applicable federal, state, or local laws.