Senior Director, Commercial Packaging, Serialization and Global Logistics

Position Overview

Bicara Therapeutics is seeking a Senior Director of Global Logistics, Commercial Packaging and Serialization that will play a pivotal role in shaping and executing Bicara's global Supply Chain strategy. This role will have immediate impact on establishment and oversight of our commercial packaging and distribution along with strategy and operational oversight of the end-to-end global logistics across both clinical and commercial supply chain.

This position reports to the Senior Vice President, Supply Chain and serves as a key member of the leadership team with close partnership and collaboration with Technical Operations, Clinical Supply, Quality, Regulatory, Commercial, Finance, Legal, and a wide range of global external partners across drug substance, drug product, packaging and commercial distribution.

This role is based in our Boston office and follows a hybrid schedule, with three in-office days each week.

Responsibilities

* Commercial Packaging

* Provides strategic leadership, functional oversight and operational oversight during the commercial packager selection process. Oversees the RFP process and packaging partner selection, contracting, qualification and ongoing performance management.

* Ensures that packaging design, artwork implementation, and labeling strategies support regulatory & global compliance requirements while meeting Bicara's commercial objectives.

* Drives all commercial packaging aspects of the future BLA submission and commercial market launches.

* Ensures alignment of all packaging components and processes with regulatory filings, specifically Bicara's first BLA submission, such as compliance of container closure systems, adherence to approved labeling as defined in regulatory submissions including strict change control and variation management, oversight of packaging validation and process qualification to meet regulatory expectations for commercial launch readiness.

* Establishes and maintains robust artwork governance, label control process and change management in collaboration with Regulatory Affairs and Quality to ensure continued alignment with approved filings for BLA and ex-US dossiers.

* Drives the design and implementation of tamper-evident, anti-counterfeiting, and patient safety features across all commercial products.

* Manages the CMO relationship - meets regularly to monitor performance, manage materials, and ensure adherence to packaging schedule. Manages commercial packaging budget and invoicing.

* Serialization

* Owns the global serialization strategy including system architecture with internal IT and external partners, drives partner integration and governance across a fully outsourced network.

* Ensures alignment of serialization capabilities with commercial launch readiness, lifecycle management, and evolving global serialization and track-and-trace regulations.

* Oversees selection, contracting, qualification, and performance management of serialization service providers and technology platforms, including integration with external providers for unit-level serialization, aggregation, commissioning and de-commissioning as applicable.

* Establish and maintain serialization SOPs and partner with relevant groups to ensure audit readiness for any regulatory inspections related to traceability, data integrity and supply chain security.

* Collaborate cross-functionally with IT, Quality, Regulatory and other stakeholders to ensure that Bicara's serialization strategy supports patient safety, anti-counterfeiting measures, returns management, and uninterrupted commercial supply.

* Global Logistics

* Assumes the global functional ownership, strategy and operational oversight for all clinical and commercial cold chain shipments of GMP materials.

* Own Bicara's cold chain strategy and execution, including qualification, validation, monitoring, and operational optimization of shipping lane and systems.

* Develop and maintain strong relationships with internal stakeholders and relevant external partners from drug substance, drug product, packaging and distribution nodes within supply chain to ensure successful implementation and oversight of the company's global logistics strategy.

* Partner with internal stakeholders within Finance, Market Access, Quality, IT and others as applicable to lead selection, qualification, contracting and performance management of the US 3PL that will handle Bicara's fully outsourced Order-to-Cash model for potential commercial launch in the near-term future.

* Trade compliance and cross-border enablement: ensure that all supply chain activities comply with global export/import regulations and customs requirements, enabling compliant cross-border movement of GMP materials across both clinical and commercial supply chain.

* Oversee integration of trade compliance into Bicara's outsourced operations, including product classification, valuation, and country-of-origin determination, import-export licensing, customs brokerage oversight and regulatory…