Hybrid Associate Director – Clinical Supplies Management

at Braveheart Bio

• Job title: Associate Director – Clinical Supplies Management
• Job type: Full Time
• Experience level: Senior
• Salary: $174,000 - $233,000 per year
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, San Francisco, United States

About the role

• Managing clinical supplies logistics and drug product distribution for biopharmaceutical trials at Braveheart Bio. Collaborate with cross-functional teams to ensure timely supply and compliance.

Responsibilities

• Ensure alignment of key activities & timelines of cross-functional team to successfully set up and supply each clinical trial, including maintaining oversight on performance and issues to ensure study supplies are provided in line with the agreed scope of work and timelines.
• Establish shipping lanes and logistics processes for new clinical trials or new clinical sites including preparation of shipping, importation and exportation documents.
• Coordinate the resolution of sample and product shipment delays and deviations with vendors, internal teams and partners. Proactively identify potential shipment delays and escalate as needed. Perform root cause analysis of shipping issues in order to identify process improvements.
• Serve as the single point of contact for key stakeholders for logistics topics.
• Provide a responsive, effective and successful high level of customer service to Clinical Operations, CMC and Nonclinical partners.
• Participate in cross-functional distribution-related projects and process improvement initiatives.
• Enhance delivery of Braveheart’s CMC objectives by fostering strong CDMO/CRO relationships.
• Use appropriate project management tools to plan and track project deliverables.
• Participate in CMC Team meetings and provide logistics and supply updates to the Vice President of Manufacturing and CMC and SVP of Development Operations.
• Facilitate tracking of the movement of drug, intermediates and samples for analytical testing between external partners.
• Analyze shipping temperature monitoring data and participate/lead investigations for excursions, in close collaboration with Quality.
• Interface between CMC and Clinical Operations to ensure planning, coordination and communication to enable timely supply of materials.
• Assist with CMC project budget planning and tracking, including invoice payments, accruals and reforecasting as needed.
• Assist with circulating RFPs, establishing contracts, amending and approving work programs.

Requirements

• Bachelor’s degree in a scientific discipline or business management
• At least 7 years of experience in logistics and/or supply chain discipline in the Biotechnology/Pharmaceutical industry; supply chain certification is a plus (e.g. APICS, CPIM, CSCP)
• Extensive experience in Global Import/Export logistics within the biotech/pharmaceutical industry
• Experience in the exportation and importation of human biologic samples and investigational drugs, specific experience in China preferred
• Proven ability to collaborate effectively on cross-functional teams, both locally and globally, building strong relationships and leading with sophistication across cultures
• Ability to influence without direct authority and communicate effectively with management, peers, customers, and vendors
• Strong organizational skills with the ability to prioritize, manage competing priorities, and work independently with high accountability
• Excellent problem-solving skills, with the ability to anticipate issues and recommend and implement solutions
• Agile learner who can move effectively between detailed execution and broader project strategy
• Experience with project integration, planning, documentation, and use of planning tools (Microsoft Project, Excel, PowerPoint and Outlook)
• Ability to work flexible hours to support global requirements
• Strong written and verbal communication skills with a collaborative, team-oriented approach
• Ability to thrive in a fast-paced, dynamic environment and remain comfortable with change and ambiguity
• Flexible, proactive, and hands-on mindset with a roll-up-your-sleeves, can-do attitude.

Benefits

• N/A