Manager/Senior Manager, Clinical Supply Chain

Location
Redwood City, CA
Posted
Apr 18, 2021
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
The Senior Manager Clinical Supply Chain will have the overall responsibility for the global supply and distribution of the Adverum’s clinical trial materials including comparator drug procurement, starting with the production planning of the Bulk Drug Substance (BDS) through drug product manufacturing, packaging and labeling ending with the distribution to the clinical sites, in compliance with all applicable laws, regulations and operating procedures. Timely and compliant supply of clinical trial materials enables Adverum to reach its clinical program goals, leading to successful regulatory filings. This position reports to the Director, Supply Chain Management.
What you'll do:
  • Manages master production plan for Adverum’s clinical trial materials from BDS through drug product to finished goods.
  • Partner with Clinical Operations to define the study drug supply strategy, requirements, distribution warehouse, import / export requirements for clinical study in line with the study protocols.
  • Works with CMC and clinical project teams developing forecasts for all clinical product supply needs and manages third party vendors to assure on time availability of clinical trial materials as owner of the Clinical Supply demand and supply planning process.
  • Responsible for coordinating and scheduling drug labeling and packaging activities in conjunction with CMC, clinical and regulatory departments.
  • Review all relevant packaging batch records and executed manufacturing batch records to ensure alignment with pertinent regulatory documentation, e.g. IND, CTAs/IMPDs.
  • Oversees vendor activities including comparator drug procurement, labeling performance, material release, on-time delivery, quality, improvement initiatives and issue resolution.
  • Responsible for logistics as required to support the labeling, packaging and shipment of clinical trial material supplies to depots/investigative sites as well as other clinical trial material supplies necessary.
  • Primary liaison for inventory control and distribution activities including scheduling, issue resolution, change implementation, expiry date management, vendor oversight and scope review related to clinical trial materials.
  • Monitors and tracks shipments to depots/investigative sites to ensure smooth transit through the logistical path, including international shipping and reconciliation, returns and/or destruction of used and unused clinical trial materials.
  • Develops label text for all Adverum clinical trial materials and coordinates label text language translations for Ex-US trials.
  • Manages clinical supply aspects of IRT vendors for Adverum clinical trials, including review of relevant documentation, completion of required User Acceptance Testing, release of study drug to clinical sites, and creation/adjustment of clinical supply strategies at depots and investigative sites.
  • Maintains collaborative relationships with third party vendors to assure the complete scope of planning activities remains connected with operations and compliant with quality requirements.
  • Prepares and reviews service provider agreements and negotiates competitive pricing.
  • Generates and reviews processes as required and ensures compliance to relevant SOPs, regulations and laws.
  • Leads clinical trial material supply process improvement efforts, developing and monitoring Key Performance Indicators
  • Creates and revises relevant SOPs as required.
  • Develops drug supply training materials for investigational sites.
  • Supports development and maintenance of pharmacy manuals for all Adverum clinical trials in conjunction with relevant cross functional leads.
  • Implements Industry Best Practices and templates for clinical trial material supply activities.

About you:
  • A minimum of bachelor’s degree is required, an advanced degree is preferred
  • A minimum of five (5-7) years of work experience in pharmaceutical industry of which at least three (3) years as clinical supply manager. Experience with biologics and cold chain products preferred.
  • Demonstrated experience in forecasting clinical trial material needs in international clinical trials
  • Relevant experience from start-up environment is required
  • Must be comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
  • Solid understanding of current GMP/GCP requirements and other relevant pharmaceutical industry procedures and regulations. I
  • Experience with IRT systems (IVR/IWR)
  • Demonstrated ability to work independently and to influence and negotiate with cross-functional teams at various levels within organization  
  • Ability to create and deliver business cases and updates to Senior Leadership  
  • Ability to adapt effectively to rapidly changing organization structures and dynamics, clinical study design changes and regulation changes
  • Demonstrated ability to work with third party vendors and service providers
  • Independent self-starter, excellent team player

About Us
Adverum is a clinical-stage gene therapy company targeting unmet medical needs in ophthalmology and rare diseases. Adverum develops gene therapy product candidates designed to provide durable efficacy by inducing sustained expression of a therapeutic protein. Adverum’s core capabilities include clinical development, novel vector discovery and in-house manufacturing expertise, specifically in scalable process development, assay development, and current Good Manufacturing Practices quality control.

At Adverum, Inclusion and Diversity are at our core. We believe in the power of being your authentic self.  We strive to create the space which allows for everyone in our Adverum Community to not only feel safe but encouraged to speak, learn from each other, grow in their professions and be the very best versions of themselves no matter what their age, ethnic background, gender, origin, religion or sexual orientation