Director/Sr. Director, Clinical Supply Chain Management - BridgeBio

About Eidos Therapeutics & BridgeBio Pharma

Eidos Therapeutics, an affiliate of BridgeBio Pharma, is a Phase 3 developmental-stage biopharmaceutical company focused on addressing the large and growing unmet need in diseases caused by transthyretin, or TTR, amyloidosis, or ATTR. We seek to treat this well-defined family of diseases at their collective source by stabilizing TTR. Our investigational product, acoramidis (AG10), is an orally administered small molecule designed to potently stabilize TTR, a potentially best-in-class treatment aiming to halt the progression of ATTR diseases.

BridgeBio is a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. We bridge the gap between remarkable advancements in genetic science in academic institutions and the delivery of meaningful medicines to patients. Founded in 2015, the company has built a portfolio of 30+ drug development programs ranging from preclinical to late-stage development in multiple therapeutic areas including genetic dermatology, precision oncology, cardiology, endocrinology, neurology, pulmonology, and renal disease, with two approved drugs.

Our focus on scientific excellence and rapid execution aims to translate today’s discoveries into tomorrow’s medicines. We have U.S. offices in San Francisco, Palo Alto, and Raleigh, with small satellites in other parts of the country. We also have international offices in Montreal, Canada, and Zurich, Switzerland, and are expanding across Europe.

Who You Are

The Director/Sr. Director, Clinical Supply Chain Management will be responsible for end-to-end clinical supply chain management activities related to managing the supply of Investigational Products (IP), including packaging, labeling, distribution, and demand forecasting for multiple clinical studies through all stages of clinical development. The role will partner closely with Clinical Operations and CMC/Manufacturing teams and partner stakeholders to ensure a timely and uninterrupted supply of IP required for clinical studies. The individual must have the ability to work independently, manage staff, and be an effective team member in a fast-paced environment.

Responsibilities

• Manage all aspects of clinical packaging and labeling activities, including label design, translation, production, distribution, and inventory management
• Act as a key interface between the CMC and clinical operation teams
• Provide total demand and translate the total demand into a demand forecast over time based on a clinical protocol or study overview
• Prepare a supply plan to support the demand forecast, including the determination of supply overage amounts, monitor inventory, and provide regular inventory updates to project teams
• Monitor drug expiry/retest dating; initiate inventory release and re-supply, serving as the unblinded inventory manager
• Manage domestic and international distribution and logistics for clinical programs, including importing and exporting clinical supplies and developing distribution instructions with clinical supply vendors
• Coordinate logistics of material transfer for drug substance, drug product, and components to/from international CMO’s, managing exportation, applicable USDA/FDA licenses and permits, VAT recovery, and customs brokers
• Investigate and work collaboratively with QA to resolve shipping temperature excursions, investigations, and deviations in a timely manner
• Support budget activities, including managing proposals, contracts, PO generation, and invoicing approvals for clinical packaging/distribution/storage
• Generate and maintain SOPs and ensure updates and compliance with industry standards
• Develop strong internal collaboration with stakeholders, such as Clinical Operations, Regulatory Affairs, Quality, Manufacturing, and Pro

No matter your role at BridgeBio, successful team members are:

• Patient Champions, who put patients first and uphold strict ethical standards
• Entrepreneurial Operators, who drive toward practical solutions and have an ownership mindset
• Truth Seekers, who are detailed, rational, and humble problem solvers
• Individuals Who Inspire Excellence in themselves and those around them
• High-quality executors, who execute against goals and milestones with quality, precision, and speed

Education, Experience & Skills Requirements

• At least ten (10) years of experience in Clinical Supply Chain Management and/or Manufacturing functions in the pharmaceutical and/or biotechnology industries. Title based on experience
• Bachelor’s or Master’s Degree in a scientific discipline
• Detailed understanding of the pharmaceutical business, especially clinical development and manufacturing
• Proven experience with forecasting, demand/supply planning, inventory management, clinical, packaging, labeling, and distribution, including cold chain, import/export, and reverse logistics
• Experience with clinical blinding practices
• Experience in assisting with the set-up of IRT Systems for global clinical studies
• Demonstrated skills in project management and CMO/CRO vendor management
• Working knowledge of the drug development process (Phase I-IV)
• Working knowledge of current GMP/GCP/GDP guidance and regulations
• Familiar with US and EU import/export regulations
• Excellent attention to detail, strong data analysis, problem-solving solving and decision-making ability, all while working in a fast-paced and dynamic environment
• Proven ability to effectively develop, communicate, and gain support for execution plans with a wide range of stakeholders
• Experience with managing and developing staff
• Ability to handle multiple projects simultaneously
• Position may require occasional evening and/or weekend commitment
• Position may require occasional travel (up to 20%), domestic and international.

What We Offer

• Patient Days, where we are fortunate to hear directly from individuals living with the conditions we are seeking to impact throughout the year and learn how we can improve our efforts
• A culture inspired by our values: put patients first, think independently, be radically transparent, every minute counts, and let the science speak
• An unyielding commitment to always putting patients first.
• A de-centralized model that enables our program teams to focus on advancing science and helping patients. Our affiliate structure is designed to eliminate bureaucracy and put decision-making power in the hands of those closest to the science
• A place where you own the vision – both for your program and your own career path
• A collaborative, fast-paced, data-driven environment where we inspire ourselves and each other to always perform at the top of our game
• Access to learning and development resources to help you get in the best professional shape of your life
• Robust and market-competitive compensation & benefits package (Base, Performance Bonus, Equity, health, welfare & retirement programs)
• Flexible PTO
• Rapid career advancement for strong performers
• Potential ability to work on multiple BridgeBio Pharma programs across multiple therapeutic areas over time
• Partnerships with leading institutions
• Commitment to Diversity, Equity & Inclusion