What are the responsibilities and job description for the Director/Sr. Director, Clinical Supply Chain Management San Francisco, CA/Hybrid position at 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.
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 CMOs, 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 Project Management
No matter your role at BridgeBio, successful team members are :
Education, Experience & Skills Requirements
What We Offer
At BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence, and performance during the interview process. BridgeBio is a multi-state employer, and this salary range may not reflect positions based in other states.
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