Manager, Clinical Supply Chain (Contract)
Redwood City, CA
Technology Development – Manufacturing & Supply Chain /
Contract /
Remote
Adverum is a clinical-stage company that aims to establish gene therapy as a new standard of care for highly prevalent ocular diseases with the aspiration of developing functional cures to restore vision and prevent blindness. Leveraging the capabilities of its proprietary intravitreal platform, Adverum is developing durable, single-administration therapies, designed to be delivered in physicians’ offices, to eliminate the need for frequent ocular injections to treat these diseases. Adverum is evaluating its novel gene therapy candidate, ixoberogene soroparvovec (Ixo-vec), as a one-time, IVT injection for patients with neovascular or wet age-related macular degeneration. Additionally, by overcoming the challenges associated with current treatment paradigms for debilitating ocular diseases, Adverum aspires to transform the standard of care, preserve vision, and create a profound societal impact around the globe.
Note to Recruiters and Agencies
All recruiter and agency inquiries must go through Adverum’s internal Talent Acquisition team. Unsolicited resumes sent to Adverum will be considered property of Adverum. Agencies must be expressly engaged by Adverum’s Talent Acquisition team for any requisition. Direct contact with hiring managers by agencies will not be tolerated and may affect your ability to work with Adverum in the future.
We are seeking an experienced and strategic Clinical Supply Chain Manager contractor to oversee and optimize our end-to-end supply chain processes within a biotech environment. This role is pivotal in ensuring efficient shipping, accurate inventory management, effective planning, and leveraging advanced analytics to drive continuous improvement.
This role is integral to Adverum’s mission to establish gene therapy as a new standard of care for leading causes of vision loss.
What you'll do:
- Develop KPIs and monitor vendor performance and address any issues or discrepancies promptly.
- Establish and maintain effective. Transparent Supply Chain business processes.
- Ensure that GCP, regulatory and clinical protocol requirements are followed.
- Manage relationships with CMOs and key suppliers including coordination, communication, technical oversight and escalation to ensure timely delivery, shipment and distribution of drug products, comparators and other ancillary supplies to support global clinical trials.
- Perform study closeout activities including returned goods reconciliation and inventory destruction processing, as applicable.
- Develop and maintain detailed inventories of clinical materials at CMOs, sites and depots, perform monthly reconciliation to ensure there are adequate materials to meet trial requirements and address potential risk.
- Create and maintain accurate forecasts for clinical trials.
- Manages inventory of Adverum’s clinical trial materials to meet clinical trial requirements.
- Partner with Clinical Operations to define and update the study drug supply strategy, requirements, distribution warehouse, import / export requirements for clinical study in line with the study protocols.
- 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.
- Leads IRT building for study with particular focus on clinical supply aspects of IRT 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.
- Identifies and supports the qualification of new suppliers/vendors in collaboration with other departments.
- Prepares and reviews service provider agreements and negotiates competitive pricing.
- Anticipate supply chain interruptions based on industry trends and prepare contingency plans for safety stock as appropriate.
- Generates and reviews processes as required and ensures compliance with relevant SOPs, regulations and laws.
- Facilitate regular meetings with cross-functional teams to ensure alignment and coordination of clinical supply activities
- Leads clinical trial material supply process improvement efforts, developing and monitoring Key Performance Indicators
- Prepare and adhere to supply chain Standard Operating Procedures and work instructions.
- 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.
- Implement 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 6- 10 years of work experience in the pharmaceutical industry of which at least three (3) years in a supply chain related role. Experience with biologics, and cold chain products is a must.
- Demonstrated ability to learn software applications related to Supply Chain and proficiency in Microsoft Office Suite.
- Demonstrated experience in developing and managing forecasts for clinical or commercial supply chains.
- International/global experience preferred.
- Deep understanding of regulatory, GDPR, data privacy, HIPA and import/export requirements.
- Solid understanding of current GMP/GCP requirements and other relevant pharmaceutical industry procedures and regulations.
- Experience with IRT systems (IVR/IWR) is a must.
- 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
- Must be comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
- Highly organized and detail oriented.
- Strong Analytical and problem-solving skills.
$55 - $65 an hour
This is a contract role, starting at 6 months. Hourly rate will depend on experience and location.
The hourly range for this position is $55.00/hr to $65.00/hr USD. This hourly range is an estimate, and the actual range may vary based on a candidate’s qualifications, including education, length of experience, location, and market data.
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.
