Associate Director, Supply Chain
: Job Details :

Associate Director, Supply Chain

Bicara Therapeutics is seeking a highly motivated Clinical Supply Chain leader with extensive clinical management experience. This individual will collaborate with primarily Clinical but other departments as well to ensure sites and depots are stocked appropriately.

Responsibilities

• Responsible for managing clinical supplies for global clinical trials associated with multiple programs at various stages (Phase 1, 2, 3 and Late Phase)

• In addition to clinical study support, other responsibilities include protocol interpretation, demand planning, inventory management and inventory reconciliation.

• Interacts and communicates with Clinical Operations and CRO for day-to-day operations

• Responsible for Drug Supply Manager role in the selected Interactive Response Technology (IRT) for management, maintenance, and oversight. Will help with lot release, set-up and distribution activities as well as establish/monitor IRT parameters and settings. Will support with specification design and UAT design as necessary.

• Responsible for maintaining inventory safety stock targets at all clinical sites.

• Primary unblinded Drug Supply or Supply Chain within the IRT system.

• Provides Logistical Support as needed. Responsible for Distribution and Logistic activities of Clinical Trial Materials between global depots. This can include non-site shipments and bulk shipments. Candidate must be knowledgeable in import/exports regulations, understanding and providing the required shipping documentation (i.e. invoices, bill of lading, etc.), and coordinating pickup reservations and monitoring logistic partners performances

• Revise and create department SOPs and Work Instructions as needed

• Work collaboratively with CMC, Regulatory Affairs and QA to ensure country approvals are aligned with supply management downstream activities (support lot release with country controls in the IRT system).

• Work with QA on timely packaging/labeling batch releases

• Create/Maintain Supply Chain related Standard Operating Procedures (SOPs) and Work Instructions (Wis)

• Review and complete Temperature Excursion investigations (shipping and site excursions).

• Support other tasks as required by Supply Chain Management such as review inventory reports for accuracy and integrity, track shipments to its destination, review and close out reported temperature excursions, and conduct shipping validation studies as needed.

• Participate in Inspection Readiness efforts, ensuring Supply Chain is fully prepared for both internal and external audits

• Track Supply Chain deviations and CAPAs; work to resolve reoccurring problems with permanent solutions.

• Support comparator sourcing activities as necessary.

Qualifications

• Requires a Bachelor's degree (preferably in Supply Chain Management) with a minimum of 7 years' experience in a clinical supply chain management role in the biotechnology/pharmaceutical industry.

• Experience working with CROs and Clinical Operations directly

• Experience with managing clinical trial supplies from early to late phases of clinical studies; including double-blinded studies

• Manage supplier oversight activities and supplier performance

• Good interpersonal skills, able to collaborate effectively with cross-functional teams and external partners.

• Excellent project management and communication skills.

• Demonstrate knowledge of clinical trials, drug development, and regulatory guidance (e.g. cGMP, GDP, GCP, ICH requirements)

Company Overview

Bicara Therapeutics is a clinical-stage biotechnology company developing first-in-class biologics engineered to bring together the precision of targeted therapy and the power of tumor modulators. The company's bifunctional antibodies are designed to deliver an immunomodulatory payload directly to the tumor microenvironment to ramp up immune cell activity, potentially offering long-lasting efficacy. Bicara's lead asset, BCA101, a first-in-class EGFR / TGF-β-trap bifunctional antibody, is currently enrolling patients in a Phase 1/1b study. Bicara's experienced team brings deep expertise across immunology, oncology, clinical development, business development and operational strategy. More information is available at www.bicara.com. Here at Bicara, we believe in building diverse teams and cultivating a culture where all voices are included. We encourage people from all backgrounds to apply.

Bicara Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

To apply, please email your resume/CV to ...@bicara.com. In the subject line include your name and the job title