Associate Director/Director, Clinical Supplies Management

External

Braveheartbio · San Francisco, CA

Full-timeRemote3w ago

AgileClinical TrialsLeadershipMoveProcess Improvement

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About the role

Braveheart Bio is a Bay Area-based biopharmaceutical company pioneering best-in-class therapies for cardiovascular disease. Our lead program is a next-generation myosin inhibitor, licensed from Hengrui Pharma, being developed to transform the treatment of hypertrophic cardiomyopathy (HCM)-the most common inherited cardiac disease. Currently in Phase 3 clinical development in China for the more common obstructive form of HCM, our candidate has demonstrated a compelling clinical profile that may position it as a best-in-class therapy with meaningful differentiation. With a proven leadership team, a strong financial foundation, and a high-value late-stage asset, Braveheart Bio represents an outstanding opportunity for ambitious, mission-driven professionals to make a tangible impact in a high-profile and rapidly evolving therapeutic area. T he Associate Director/Director, Clinical Supplies Management will lead Braveheart's efforts to produce and distribute packaged drug product to clinical trial sites , and establish the procedures for label-pack and distribution activities for eventual commercialization of Braveheart products. Reporting into the SVP, Development Operations , you will be responsible for inter-site shipping logistics for drug substances and drug products, ancillary materials, intermediates and samples between external partners, including materials for non-clinical studies, clinical trials, and analytical testing. As a member of Braveheart's CMC (Technical Operations) team, the successful candidate will interface with a diverse team representing Manufacturing and Quality; Program Management, Clinical Development, Clinical Operations, Finance and external partners to support key tasks related to planning, shipping & logistics , labeling, packaging and distribution of investigational materials.

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.

Required experience & skills:

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 execut

Associate Director/Director, Clinical Supplies Management

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