Sr. Manager/AD, Clinical Supply Chain Management & Operational Excellence

BridgeBio Pharma•San Francisco, CA

8d•Hybrid

About The Position

The Sr. Manager, Clinical Supply Chain Management & Operational Excellence is responsible for supporting SCM operational excellence projects to streamline SOPs and make processes more efficient. This individual will also support end-to-end clinical supply chain management activities which include: coordinating investigational medicinal product (IMP) planning, forecasting, labeling, packaging, distribution, inventory monitoring, and reconciliation for assigned clinical studies. This position reports to the Director, Supply Chain Management.

Requirements

5+ years of progressive experience in Supply Chain within the biotech/pharmaceutical industry
A minimum of 3 years in a global forwarding/trade compliance operation role for clinical/commercial products, including import/export experience and temperature-controlled distribution protocols, manage ad hoc Customs compliance issues in a regulated pharmaceutical/biotech environment
Bachelor’s degree in Supply Chain, Business Administration, Operations Management, or similar required
In-depth understanding of project management processes like Lean/ Six Sigma
Understands comprehensive global pharmaceutical regulatory requirements (e.g., cGMP, GDP, 21 CFR Part 11) and Knowledge of relevant local pharmaceutical drug product laws and regulatory guidelines
Strong ability to collaborate and build strategic relationships with internal (Quality, Supply Planning, CMC/Manufacturing, etc.) and external (CMO, Couriers, etc.) stakeholders
Strong understanding of import/export requirements and customs practices
Able to independently resolve any global import & export issues, especially the logistics issues in the US/Europe
Experience in vendor oversight and managing external partnerships and relations
Experience in deviation investigation and CAPA implementation
Demonstrated ability to work in a fast-paced team environment that requires quick turnaround and quality output, with minimal supervision and solid power to multi-task across competing priorities to achieve success
Ability to foster a culture of continuous improvement and operational excellence and perform as a potential, influential leader without positional authority
Proficient in Microsoft Office applications, IRT, and ERP systems preferred

Responsibilities

Leads continuous improvement projects to optimize processes by analyzing KPI, and fostering cross functional collaborations for improvements
Develop and manage SOPs, work instructions, processes, systems, and forms governing supply chain management, including international logistics, in alignment with industry standards and regulatory requirements
Support projects and process improvement efforts related to supply chain management, both clinical and commercial
Support budget activities, including managing proposals, contracts, PO generation and invoicing approvals for clinical packaging/distribution/storage
Strengthen oversight and tracking of Trial Master File (TMF) documents, ensuring timely, accurate, and inspection-ready documentation for all clinical supply activities.
Work with external courier and depot vendors to set up storage, Import & Export, distribution, drug return, and destruction according to the Logistics SOP/Global Standards (GDP) and related logistics procedures
Facilitates and coordinates with parcel carriers, couriers, and logistics brokers regarding all aspects of service, including pre-conditioned shipping containers/materials, temperature data loggers, pick-up appointments, and expedited order and emergency delivery situations
Leads and oversees the execution of temperature-controlled, on-time distribution of Eidos drug supply chain, ensuring on-time delivery and manage temperature excursions as needed
Coordinate with external bureaus, including Customs, FDA, USDA, and/or other applicable country agencies, to resolve logistics issues in a timely manner
Ensures the requirements and business processes associated with cross-border movements function smoothly, issues and risks are identified and managed efficiently
Importer Of Record setup and management as applicable globally and supports import permit applications and corresponding import VAT refund as needed
Works with internal departments including QA, Finance, Tax, procurement, Legal, and RA to resolve logistics issues, as required
Collaborate with Clinical Operations and internal stakeholders to align on clinical demand requirements and ensure labeling and distribution plans remain adaptive to program timelines, study design changes, recruitment needs, geographic considerations, and manufacturing schedules.
Act as CMC/Supply Chain SME for any potential audits
Collaborate with QA counterparts to ensure inspection readiness and process control for all import/export and applicable clinical trial activities; may participate in regulatory inspections
Manage and assess courier vendor’s performance and reports operational metrics (KPIs) to senior management and any regulatory reporting requirements related to import and export activities
Assist in the process of identifying potential supply chain vendors, reviewing proposals contributing to the selection process

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
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
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