Manager/Sr. Manager/AD Clinical Supply Chain

Profile

RemeGen Biosciences is a biopharmaceutical company, focusing on the discovery and development of innovative biologics for the treatment of cancers, autoimmune and ophthalmic diseases, based in South San Francisco, CA, and Rockville, MD. By leveraging our deep insights into oncology and immunology, advanced protein engineering/design technologies, and extensive knowledge in clinical development, our vision is to uncover the novel therapeutic targets and develop the best-in-class and first-in-class biotherapeutics for patients with significant unmet medical needs. RemeGen Bioscience is a wholly owned subsidiary of RemeGen, a global pharmaceutic company specialized in autoimmune, oncology and ophthalmic diseases.

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The Manager/Sr. Manager/AD, Clinical Supply Management will be responsible for clinical supply chain operations in various phases at CDMO. A successful candidate will demonstrate leadership ability, end-to-end clinical supply chain expertise (managing all aspects of clinical supplies in a global trial setting), be able to work independently and enjoy working in a dynamic, fast-paced environment during a period of significant growth.

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Responsibilities (including, but not limited to):

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• Review clinical protocols and translate clinical study requirements into demand for clinical trial materials (including medical devices and/or ancillaries as required) for supporting multiple global clinical studies.
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• Manage all clinical supply activities for on-time delivery, which includes demand forecasting, trial monitoring & resupply planning, packaging/distribution, Interactive Response Technology (IRT) set-up and distribution activities.
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• Strategically manage procurement, packaging, labeling, distribution, returns, reconciliation, destruction and storage tasks for all clinical trial materials (including medical devices and/or ancillary as required).
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• Review and approve documentation related to packaging, labeling, and distribution of clinical trial materials. Maintain appropriate documentation in compliance with domestic and international regulations.
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• Manage clinical trial materials distribution and logistics for global clinical programs, including importing and exporting clinical supplies.
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• Support the procurement, labeling and distribution of comparators.
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• Work collaboratively with Clinical Operations, Quality Assurance and Regulatory Affairs to develop supply strategy to maximize supply efficiency, minimize waste, and develop risk mitigation plans to proactively identify any potential issues that may impact drug supply
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• Work with the clinical team to configure and set up Interactive Response Technology (IRT) Systems including automated randomization and drug supply management, including specification design & UAT testing.
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• Manage study closeouts and drug reconciliation at study end
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• Develop and manage clinical supply budget and negotiate contracts with vendors.
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Qualifications:

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• Requires a BS degree with a minimum of 5 years’ experience in a clinical supply chain management role in a biotechnology/pharmaceutical industry.
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• Experience managing contract packaging and labeling organizations (strongly preferred).
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• Experience with developing risk-based Clinical Trial Supplies management from early to late phases international clinical studies (double-blind, comparator).
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• Manage vendor oversight activities and vendor performance to ensure high-quality, cost-effective execution of outsourced clinical supply activities.
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• Detailed understanding of regulatory requirements for clinical supply distribution in US, APAC, and EU including testing and labeling requirements.
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• Detailed understanding of regulatory and Good Manufacturing Practices and Good Distribution Practices requirements for IMP supply and national/international transportation requirements for pharmaceutical materials.
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• Global distribution experience including working with QP, IXRS and regional depots.
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• Must thrive in a fast-paced innovative environment while remaining flexible, proactive, resourceful and efficient
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• Excellent project management and communication skills
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• 10 to 15% travel may be required (including international travel).
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rn,datePosted:2022-02-25T19:55:00 00:00,validThrough:2022-03-28T03:59:00 00:00,employmentType:FULL_TIME,hiringOrganization:{name:**MEMBERS ONLY**SIGN UP NOW***.,@id:2191019,url:****San Francisco, California,address:{addressCountry:US,addressLocality:California,addressRegion:California,postalCode:94080,@type:PostalAddress},@type:place},industry:Clinical, Manufacturing & Production, Materials/Inventory Control, Supply Chain, Science/R&D, Biotechnology,workHours:Full time,educationRequirements:Bachelors Degree,@type:JobPosting,@context:****

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