- Liaison for inventory control and distribution activities including scheduling, issue resolution, change implementation, vendor oversight and scope review related to clinical and ancillary supplies. Experience in managing the logistics of cold-chain and cryogenic supplies and sample shipments is strongly preferred.
- Has ownership of clinical supply and sample logistics plans for clinical trials.
- Authors pharmacy manuals, drug administration manuals, and clinical supplies Standard Operating Procedures. Responsible for logistics, as required, to support the labeling, packaging and shipment of clinical drug supplies to depots/investigative sites, as well as study test kits and clinical samples to and between analytical vendors, as necessary.
- Manages and works with third party vendors, site personnel, and functional leads; interfaces with CMC for awareness of production planning and distribution; develop forecast of all drug supply needs and work with CMC to ensure supply chain goals are met.
- Coordinates periodic "sweeps" of sites to organize shipments of collected clinical samples to send to analytical vendors for batch or individual analysis.
- Monitor inventory levels and supply expiration dates of all study drugs and ancillary products kept at storage depots and clinical sites through the life of a trial; take preventative actions to avoid potential short or expired supply issues.
- Monitor and track shipments to ensure smooth transit through the logistical path - including international shipping. Familiarity with the requirements of international product and patient sample importation is preferred.
- Proactively drive the labeling, packaging, release, and distribution of clinical supplies at external CMOs for assigned studies, including forecasting for future requirements, and ensuring that the project timeline is met or exceeded.
- Ensure domestic and international distribution arrangements are in place with external vendors to allow shipment following availability of technical and regulatory releases. Organize shipment strategies to facilitate batched or individual clinical sample analysis, with specimens originating from domestic and international sites.
- Partner with key stakeholders (including Quality Assurance and Regulatory Affairs, and CMC) to ensure supplies are labelled and released for clinical site shipment for clinical trials use. Assist with the resolution and adjudication of any controlled-temperature clinical supplies or samples that have had a temperature excursion.
- Involved in all finance activities (e.g., reconciliation of invoices with the vendor's budget) with clinical team, including requests for purchase orders and invoice approvals.
- Work closely with Clinical Operations to monitor and track clinical trial enrollment plans and actual enrollment.
- Represent the clinical supplies and sample logistics function at clinical trial team meetings; communicate plan and timelines to internal and external customers and partners.
- Ensure appropriate system documentation is transferred to TMF, with "near real-time" inspection readiness.
- Utilize appropriate software and IT systems to effectively manage key project activities.
- Undergraduate degree in the Life Sciences, Supply Chain Management, or equivalent work experience.
- Minimum of 3 years' experience in clinical drug supply management, clinical sample management, and site supply management. Familiarity with cold chain logistics is strongly preferred.
- Outstanding organizational and interpersonal skills, and outstanding ability to manage relationships and influence others.
- Proven knowledge of relevant FDA regulations.
- Superior oral and written communication skills are required, and the ability to work effectively with senior management. Strong analytical skills.
- Strong creativity, independent thinking and results orientation is required.
- Must have high ethical standards and impeccable integrity.
- Ability to understand stakeholder concerns and frame issues/proposals to influence decision-making.
- A beautiful facility
- An entrepreneurial, highly collaborative, and innovative environment
- Comprehensive benefits, including:
- Medical, Dental, and Vision
- Group Life Insurance
- Long Term Disability (LTD)
- 401(k) Retirement Plan
- Employee Assistance Program (EAP)
- Flexible Spending Account (FSA)
- Paid Time Off (PTO)
- Company paid holidays, including the year-end holiday week
- Our recognition program, , is where you can trade in points earned for things you want.
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Associate Manager, Clinical Logistics - San Diego, United States - Artiva Biotherapeutics
Description
About Artiva:
Artiva Biotherapeutics is an immunotherapy company with the ability to produce off-the-shelf, allogeneic NK cell therapies at a massive scale.
Our lead program, AlloNK, is an allogeneic, non-genetically modified NK cell therapy candidate designed to enhance the activity of monoclonal antibodies or NK cell engagers.
AlloNK is currently in clinical trials in combination with rituximab for treatment of systemic lupus erythematosus (SLE) in patients with active lupus nephritis and for treatment of Non-Hodgkin Lymphoma, as well as in combination with Affimed's innate cell engager AFM13 for the treatment of patients with relapsed/refractory CD30-positive lymphomas.
Job Summary:
The Associate Manager, Clinical Logistics, will oversee clinical supply management, including packaging, labeling, monitor inventory levels, logistics and distribution, by interacting with internal and external supply partners/vendors to ensure supply of Artiva products are sufficient at depots and clinical sites.
Also responsible for overseeing the periodic shipment of test kits and patient samples collected during clinical trials, including from sites to analytical vendors and/or between vendors.
Duties/Responsibilities:
Qualifications:
Why you should apply:
We have a fantastic team and philosophy We are passionate - we deeply care about our team, our science, and improving the lives of cancer patients.
We are tenacious - laser-focused on our mission and undeterred in our commitment to deliver life-saving medicines for cancer patients.
We are innovative - pushing into new frontiers for patient benefit. We are transparent - believers in flat, accessible, and open communication paths. We are inclusive - committed to the diversity of our team and ensuring that all voices are heard.In addition to a great culture, we offer:
Artiva Biotherapeutics is an equal employment opportunity employer.
Base Salary:
$92,000 - $120,000. Exact compensation may vary based on skills and experience.
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