Mavericks Wanted
When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on
In 2015, we pioneered a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible.
Together we define white space, push boundaries and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the future of biopharma.
Affiliate Overview
Eidos Therapeutics, an affiliate within BridgeBio Pharma, is a commercial-stage biopharmaceutical company focused on Transthyretin Amyloid Cardiomyopathy (ATTR-CM).
What You'll Do
The Vice President of Global Supply Chain will be responsible for global end-to-end clinical supply chain activities related to managing supply of Investigational Product (IP) including packaging, labeling, distribution and demand forecasting for multiple clinical studies through all stages of clinical development. The role will also have responsibility for global end-to-end commercial supply chain activities, including the management of S&OP, Supply planning, Supplier (CMO, CPO, 3PL) management, inventory management, and partnership with Global Trade for Finished Good distribution. The role will partner closely with CMC/Manufacturing, Commercial, Clinical, and Quality Assurance teams and partner stakeholders to ensure timely and uninterrupted supply of clinical and commercial product. The individual must have the ability to manage global teams, experience in GxP industry, be an effective leader, and work efficiently in a fast-paced environment.
Responsibilities
- Manage a global team of supply chain professionals, responsible for both clinical and commercial end-to-end supply chain
- Manage all aspects of commercial supply chain, including Drug Substance and Drug Product Contract Manufacturing Organizations (CMOs), Packaging and Labeling activities with Contract Packaging organizations (CPOs), Finished Good receiving, put away, storage and distribution activities at Third Part Logistics Providers (3PLs)
- Coordinate logistics of material transfer for clinical and commercial drug substance, drug product and components to/from international CMOs/CPOs, managing exportation, applicable USDA/FDA licenses and permits, VAT recovery and customs brokers
- Own the global Sales & Operations Planning (S&OP) process for all commercial products, coordinating with global market access team for demand planning, finance team for financial planning and driving ownership of final supply plan to be communicated to global partners
- Own and actively manage the commercial supply plan, all commercial inventory, both in process and finished goods; manage shelf life and expiration
- Own and manage all serialization activities for commercial products globally
- Manage clinical packaging and labeling activities including label design, translation, production, distribution and inventory management
- Provide clinical demand signals, translate the total demand into a demand forecast over time based on a clinical protocol or study overview
- Prepare a clinical supply plan to support the demand, including determination of supply overage amounts, monitor inventory and provide regular inventory update to project teams
- Monitor clinical 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
- Support budget activities, including managing supplier contracts, PO generation and invoicing approvals for clinical and commercial purchases
- Work collaboratively with QA to manage supply chain activities such as batch release, final release, temperature excursions and to support the investigation of any deviations in a timely manner
- Work with CMC as a liaison to clinical operations and also on the evaluation of new CMOs or CPOs for commercial supply chain
- Work with Global Trade & Distribution and global Finance teams to manage global 3PLs, ensuring quality Finished Good inventory management, distribution and logistics, sales and revenue reporting
- Generate and maintain global SOPs in Veeva QMS and ensure updates and compliance with industry standards
- Develop and maintain strong internal cross-functional collaboration with stakeholders, such as CMC, Clinical Operations, Market Access, Finance, Quality, and Regulatory Affairs
Where You'll Work
This is a hybrid role and requires in-office collaboration 2-3x per week in our San Francisco Office.
Who You Are
- At least fifteen (15) years of experience in 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, including both clinical development and manufacturing and commercial manufacturing and supply chain
- Proven experience with forecasting, demand/supply planning, inventory management, packaging, labeling and distribution including cold chain, import/export and reverse logistics
- Proven experience managing and developing a team of professionals
- Experience with SAP or similar ERP platform
- Experience with product serialization, TraceLink or other similar platform and DSCSA standards
- Experience with Veeva, or other similar QMS platform
- Experience with clinical blinding practices
- Experience in assisting set-up of IRT Systems for global clinical studies
- Demonstrated skills in project management and vendor management
- Working knowledge of 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, problems 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
- Ability to handle multiple projects simultaneously
- APICS certification or supply chain education preferred
- Other Information:
- Position may require occasional evening and/or weekend commitment
- Position may require occasional travel (up to 20%), domestic and international
- Salary is competitive and commensurate with experience and qualifications
Rewarding Those Who Make the Mission Possible
We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return.
Financial Benefits:
- Market leading compensation
- 401K with 100% employer match on first 3% & 50% on the next 2%
- Employee stock purchase program
- Pre-tax commuter benefits
- Referral program with $2,500 award for hired referrals
Health & Wellbeing:
- Comprehensive health care with 100% premiums covered - no cost to you and dependents
- Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)
- Hybrid work model - employees have the autonomy in where and how they do their work
- Unlimited flexible paid time off - take the time that you need
- Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents
- Flex spending accounts & company-provided group term life & disability
- Subsidized lunch via Forkable on days worked from our office
Skill Development & Career Paths:
- People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility
- We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching
- We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities
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