Associate Director, Clinical Supply

Position Summary

The Associate Director of Clinical Supplies Planning and Logistics will be responsible for managing the investigational clinical drug supplies across the AnaptysBio portfolio. The role is primarily responsible for supporting Biologics Project Management, CMC, Quality and Clinical Supply Operations by translating clinical protocols into actionable development and study supply plans, managing work streams with key service providers and working with internal cross-functional departments and vendors for on-time deliveries of clinical supplies.

Essential Functions

• Develops clinical study supply plans and maintains inventory tracking for both active clinical and placebo drug products as well as bulk biologic substances and intermediates in compliance with company's internal procedures and GxP requirements.
• Prepares clinical trial material forecasts at the study level and tracks material inventory, update use and expiry dating to ensure uninterrupted clinical supplies. Proactively elevates to management when action is necessary, including shelf life extension or resupply submission to health authorities are necessary.
• Participates on project teams and provides clinical supply updates and summaries to management. Supports management with implementation of departmental strategies and policies.
• Oversee global clinical drug supply activities associated with project team's trials (secondary packaging vendor selection, technical batch record review, QP release coordination, clinical label design, packaging and labeling, IRT efficiencies).
• Vendor Management – Prioritize labelling and packaging activities at CROs/CMOs, serving as Person in Plant (PIP) when packaging operations for clinical trial material are in-process.
• Establishes packaging design based on protocol and manages all packaging activities including work order creation, review and approval of contractor packaging records and monitoring work at contractors.
• Coordinates CTM shipping and logistics activities including management of shipments of CTM from storage/distribution sites to clinical trial sites.
• Coordinates courier deliveries and shipments, and manages the courier relationship. Oversee packaging of materials according to current regulations. Oversee special projects, including international shipments requiring US Government certificate / license for worldwide shipment of investigational clinical trial material, drug substance, and drug product.
• Reviews temperature logs for CTM distribution and storage. Investigate temperature deviations according to SOP.
• Actively communicates supply plan progress to all stakeholders. Builds and maintains positive working relationships with co-workers and functional areas to accomplish project objectives.
• Reviews and tracks manufacturing documentation required for submissions to regulatory authorities. Supports regulatory filings, submissions, and responses.
• Analyzes stability data for adverse trends for each product. Elevates to management when action is required. “Actions” include field alert reports, product recalls/withdrawals, manufacturing process changes, and product specification changes.
• Performs and supports clinical site, depot or CMO audits as required.

Knowledge and Competencies

• Ability to work independently to make strategic decisions related to planning and budgeting.
• Understanding of cGMPs and current pharmaceutical industry procedures and regulations.
• Hands on experience with Interactive Web Response System (IVRS/IWRS) clinical supply software.
• Strong, open and transparent communication skills (verbal and written).
• Solid organizational and time management skills.
• Project management skills and computer proficiency.
• Experience with: MS Excel, Word.
• Ability and willingness to travel 10% of the time (internationally and domestically)

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to finger, handle, or feel. The employee is occasionally required to stand, walk, and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision and ability to adjust focus in order to read.

Work Environment

The work environment characteristics are representative of those an employee encounters while performing the essential functions of this job, typically in an open office environment. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• The noise level in the work environment is usually moderate. May be required to travel by plane or car.
• This position requires working with biological and/or chemical hazards.

Requirements

Qualifications

Education & Experience

• BS or Master's Degree in life science, or related field (or equivalent experience).
• 8-10 years experience in GMP supply chain or pharmaceutical program management at a CRO and/or pharmaceutical/biotech organization.
• Preferably Certificate in Supply Chain Management Program.
• Must have experience in Clinical Supplies Packaging, distribution, supply chain and project management.

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.