Associate Director, Product Supply

At Avalo (ahh-vah'-low), we share a commitment to teamwork, passion for science, and dedication to patients suffering from acute and chronic inflammatory disorders. Our cross-functional team has a deep understanding of disease pathology and clinical development of novel therapeutic targets. Our collective expertise in discovery, development, and regulatory approvals is evidenced in our strong individual track records of advancing multiple therapeutic programs to successful commercialization.

Position Summary

Avalo has an outstanding opportunity for an exceptional Associate Director, Product Supply to join our team. This role is responsible for managing the clinical drug supply labeling, ordering, shipping, and destruction at third party providers, transportation and logistics for bulk drug substance and drug product, clinical study supply reconciliation activities, and forecasting clinical demand and production schedules for Avalo and will be part of the core project team. This role will lead in close collaboration with external providers and internal stakeholders (e.g., Quality Control, Quality Assurance, Validation, Project Management, Clinical Operations, Commercial, etc.).

Responsibilities

• Be accountable for the timely release of SKUs, coordinate release prioritization, if required.
• Oversee the Manufacturing supply metrics.
• Accountable and point of contact for any supply chain ad hoc analysis
• Coordinate packaging and labeling timing for clinical and commercial launch success (components availability, scheduling).
• Collaborate with Clinical Operations and CRO’s to manage IXRS development and execution.
• Set strategic direction for Drug Product Packaging, Labeling, and Logistics outsourcing needs and nurtures relationships to make outsourcing options available.
• Develop and maintain effective interfaces with key customers (external and internal). Fully understands the clinical study and clinical supply processes; viewed by peers as a leader with a high level of respectability and complete knowledge of processes and strategies.
• Define and guarantee the execution of the manufacturing schedule in a timely and smooth manner with forecast and work orders (inclusive availability of materials, resources).
• Manage the drug supply component of the Drug Development Plan (including forecasting for manufacturing/procurement, packaging/labeling, and distribution) required for drug program and corresponding protocols and updating plan as required for changes to enrollment/projected treatment duration.
• May perform other tasks as assigned.

Qualifications

• Demonstrate a strong consistent display of team behavior by actively participating in project-related teams and is accountable for supply related component.
• Has a high level of problem-solving skills and uses them to monitor key milestones in the global clinical supply process.
• Recommends and implements ways to improve the efficiency of clinical supply processes
• Experience in Supply Demand and Operations Planning (SD&OP) activities supporting clinical and commercial launch.
• Excellent interpersonal skills. Self-motivated with a proven ability to organize project activity to meet multiple project timelines.
• Demonstrated project planning skills to make optimum use of resources and to meet timelines. Effective communication and knowledge of how to impact and influence internal and external partners.
• Demonstrated strong oral, written, verbal, and interpersonal communication skills.
• Ability to present data and analyses in an organized, clear, and concise manner.
• Ability to effectively communicate and persuade others to accomplish clinical supply goals and objectives.
• Ability to forecast and allocate resources to manage clinical supply programs with focus on meeting the program objectives.

Education/Experience

• Bachelor’s degree in business administration, Pharmacy, Biology or related science with 5-10 years of experience in the pharmaceutical industry with a focus in clinical supplies.
• APICS certification (CSCP/CPIM) desirable
• Experience in SD&OP activities supporting clinical and commercial launch.
• Strong understanding of the drug supply, distribution and packaging process.
• Demonstrated experience in strategic supply chain and supplier relationship management
• Knowledge of the global clinical supply and clinical study processes, of cGMP and GCP regulations, ICH Guidelines as it relates to Good Distribution Practices (GDPs) and local country drug shipment regulations.
• Advanced knowledge of fundamental concepts of materials requirements, planning, and procurement including: inventory management, SD&OP, expediting, third party supplier work order reviews, contract updates, and order placement
• Advanced knowledge of the full range of concepts, practices in the materials planning field, including reorder point planning, contract communication/execution
• Capability to work in a changing environment and beyond pre-defined processes
• Demonstrated success working effectively with cross-functional teams to get results through effective skills in negotiation, priority management communication (works in transparency), problem solving and decision-making.
• Knowledge of supply chain concepts and practices in Biopharmaceutical industry
• Knowledge of international customs & trade, taxation, transfer pricing and cGMP regulatory requirements

Travel

Must be able to travel (domestic/international) with overnight stays, as necessary, travel up to 20%.

EEO

Avalo is an Equal Opportunity Employer and follows strict guidelines to ensure a workplace that is open to all qualified individuals. Avalo recruits, hires, trains, and promotes in all job titles without regard to race, color, religion, national origin, gender, age, sexual orientation, veteran status, citizenship, marital status, the presence of any sensory, mental, or physical impairment, or any other basis prohibited by federal, state, or local laws.

About Avalo Therapeutics

Avalo Therapeutics is a clinical stage biotechnology company focused on the treatment of immune dysregulation. Avalo’s lead asset is AVTX-009, an anti-IL-1β mAb, targeting inflammatory diseases. Avalo’s pipeline also includes quisovalimab (anti-LIGHT mAb) and AVTX-008 (BTLA agonist fusion protein). For more information about Avalo, please visit www.avalotx.com.