Clinical Supplies and Sample Logistics Manager
Over the past decade we have seen stunning advances in the cellular immunotherapy therapy field in particular, with dramatic rates of clinical response in hematological malignancies, and rapid evolution of our understanding of factors that could extend this success to solid tumors. However, these transformative therapies are often accompanied by severe and potentially life-threatening toxicities, and patient access is limited by such factors as complex, time-consuming patient-specific manufacturing, variable product quality, and cost.
At Artiva, our mission is to deliver highly effective cell therapies that are also safe and immediately available and accessible to any patient who stands to benefit.
Reporting to the Director, Clinical Operations, the Clinical Supplies and Sample Logistics Manager will oversee all aspects of 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.
Role & Responsibilities
- Primary 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.
- 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 production planning and distribution; develop forecast of all drug supply needs and work with CMC to ensure goals are met.
- Coordinates periodic “sweeps” of sites to organize shipments of collected clinical samples to analytical vendors for batch or individual analysis.
- Monitor inventory levels and supply expiration dates of all study 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. 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.
Experience, Education and Specialized Knowledge and Skills
Must thrive working in a fast-paced innovative environment while remaining flexible, proactive, resourceful and efficient. Excellent interpersonal skills, ability to develop important relationships with key stakeholders, conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans and recommendations. Demonstrated ability to translate strategy into action. Excellent analytical skills, ability to communicate complex issues in a simple way, and ability to orchestrate plans to resolve issues and mitigate risks.
- Undergraduate degree in the Life Sciences or Supply Chain Management
- Minimum of 5 years’ experience in clinical drug supply management, clinical sample management, and site supply management.
- Outstanding organizational and interpersonal skills, and outstanding ability to manage relationships and influence others.
- Proven knowledge of 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.
We look for talented, entrepreneurial people who share our values. We are called to put the safety of our patients and employees first, and to act with integrity and the highest ethical standards. To achieve our mission, we must collaborate across the Company at all levels, and we must hold ourselves and our teams accountable for delivering the progress we commit to, on the timelines we set. We embrace diversity, we include people and their ideas, and we aspire to excellence by listening, understanding, sharing and responding. We want you to be fully engaged, to develop personally and professionally through this chapter in your life, and to have fun along the way.
Artiva Biotherapeutics is an equal opportunity employer that is committed to providing a work environment free of harassment and discrimination based upon a protected category, as well as an environment free from retaliation for protected activity.
- The opportunity to work with a team of highly experienced professionals from clinical to regulatory to CMC to research
- To be part of building a company on the cutting edge of cell therapy that may be a game changer to patients in a culture that is entrepreneurial, highly collaborative and innovative
- Competitive compensation, including bonus
- Equity program
- Health and welfare benefits – Medical, Dental, Vision, Life, 401K, EAP
To apply, please send cover letter and resume/CV to: email@example.com. We thank all applicants for your interest in Artiva but due to the number of resume submissions, only those candidates with whom we wish to speak will be contacted.