Clinical Supply (Senior) Manager/Associate Director

Lexeo Therapeutics•New York, NY

6d•Hybrid

About The Position

The Clinical Supply (Senior) Manager/Associate Director supports the cross-functional working team and independently plans and organizes tasks to meet specified objectives and timelines. This role manages supply planning and delivery of development products to clinic by supporting clinical supply inventory management, clinical supply packaging, labelling, interactive web response system (IWRS), distribution, and logistics planning. The Clinical Supply (Senior) Manager/Associate Director is responsible for clinical supply budget and tracking in addition to managing and executing the clinical supply chain for current and future clinical study programs at all development levels. This individual contributor role has a strong focus on late-stage program development and commercial launch readiness. The Clinical Supply (Senior) Manager/Associate Director also has oversight of vendors supporting Clinical Development Manufacturing Organization (CDMO), Secondary Packaging and Distribution, Comparator Sourcing.

Requirements

Bachelor's degree in life sciences, business-related field, or supply chain management; Master’s in Supply Chain Management preferred
Minimum 5 years of experience handling / leading clinical supply chain and logistics; development experience preferred; 10+ years experience (7 years experience with Master’s degree) for Associate Director level
Experience with clinical supply pack/label/distribution, clinical trial operations, project management, pharma/bio research and development, and inventory management strongly preferred
Knowledge of clinical materials production processes and design strategy for patient dose kits supporting a clinical study design
Ability to rapidly navigate the organization and identify, align, and integrate cross-functional resources into cohesive teams
Demonstrated ability to work in a highly matrixed environment and manage supply chain initiatives in a high performing team across all levels
Experience in multi-functional areas (Clinical Operations, Medical, Regulatory, Quality, Product/Process Development) demonstrating a broad understanding of pharmaceutical development, both in GCP and GMP
Expert knowledge of all phases of drug development, of the functions and processes relevant to drug development, and project management principles applicable to the biopharmaceutical environment
Extensive in planning and execution of investigational materials supply strategies
General knowledge of GxP principles is required

Responsibilities

Own the coordination and execution of all clinical supply-related activities including supply planning, cGMP secondary packaging/labelling, distribution, and logistics for clinical programs
Support IWRS User specifications and UATs
Execute clinical supply chain sourcing strategy utilizing 3rd party providers in coordination with clinical operations current and future programs
Manage supplier relationships with vendors including maintaining key performance metrics and budget/invoice tracking, review supply needs for study start-up, ongoing resupply strategies, contract negotiation, amendments and closeout requirements
Evaluate vendor selection to support clinical study supply chain according to capability and fit
Generate RFPs for vendor proposals with the ability to breakdown study protocols to support the supply strategy and communicate study needs to obtain vendor based budgeting or internal support
Contribute program budget review and invoicing considerations as it relates clinical supply chain study management and capture any impacts
Support the clinical program’s global supply chain in current and future clinical studies for clinical supply to commercial strategy. Oversee international depots and distribution as appropriate
Support governance committees for global clinical operations and global clinical supply chain
Ensure consistency across processes and develop tools to implement sustainable improvements
Manage the execution of clinical supply strategy for specific clinical programs from early to late stage development with an understanding of commercial launch readiness
Understand the roles and responsibilities of all functions represented on cross functional drug development teams to mitigate up and downstream operational deliverables
Support regulatory filings including IND and BLA submission information as it relates to a global supply chain
Provide regular updates to the TMF as per departmental requirements that comply with all regulatory requirements
Participate in clinical study team meetings, align with study details, collaborate in meeting study objectives, and provide supporting information to the teams (includes RA, RACMC, Clinical Operations, Manufacturing and Development)
Additional responsibilities as needed