Clinical Supply Chain Specialist - Drug Purchasing

Replimune

Replimune's mission is to revolutionize cancer treatment with therapies designed to activate a powerful and durable full-body anti-tumor response, boldly transforming cancer care because patient's lives depend on it. We imagine a world where cancer is a curable disease.

At Replimune, we live by our values:

United: We Collaborate for a Common Goal.

Audacious: We Are Bold and Innovative.

Dedicated: We Give Our Full Commitment.

Candid: We Are Honest With Each Other.

People are at the center of everything we do, and when it comes to our employees, we make it personal. With a deep sense of purpose, an innovative and collaborative culture, a competitive and forward-looking total rewards program, everyone at Replimune has a unique opportunity to contribute to the meaningful work we do which could impact the lives of patients.

Join us, as we reshape the future.

Job Summary:

The Clinical Supply Chain Specialist I role will assist the Operations and Clinical Development functions with clinical supply chain activities to ensure Replimune's clinical trial sites have drug available to dose patients when required. This will encompass all stages of all clinical trials, from start-up through study close out and the stages of the drug supply chain from packaging, shipping and distribution, inventory forecast and product return or destruction.

This position is based in our Framingham location and typically has a 5-day on-site expectation.

Responsibilities

Responsible for end-to-end clinical supply chain oversight activities including: packaging, distribution and shipping activities performed by third party vendors. This oversight will include the review of contracts, protocols and associated costs.

Collaboration with Clinical Supply Specialists and other cross-functional teams to understand the comparator requirements for clinical studies.

Develop sourcing strategies to deliver the comparators on time in full. The sourcing strategies are measured based on maximizing supply efficiency, minimizing waste while identifying risks and developing risk mitigation plans.

Partner with Finance, Quality and Regulatory for the selection, qualification and management of comparator sourcing suppliers in support of Replimune's portfolio.

Work with the Operations and Clinical Development functions to facilitate distribution and logistics to assure product availability in support of all clinical trials.

Accountable for communication, support, and issue resolution for site-facing drug supply management processes and on-site drug supply issues

Assist in the management, execution and user acceptance testing for IRT systems.

Monitor inventory levels at investigational sites and inform Operations, Clinical Development and Program Management of any potential issues (shortfalls, overstock, expiration dating)

Monitor distribution activities to ensure sufficient inventory levels at all sites.

Work with Clinical Development to generate, maintain and circulate regular supply forecast and drug consumption reports.

Monitor and communicate clinical study site drug usage levels on at least a monthly basis.

Ensure work is completed in compliance with GXP and company SOPs

Qualifications

Education:

Bachelors Degree strongly preferred

Required Experience:

5+ years of relevant experience, including at least 2 yrs of experience in Supply Chain

Ability to work independently and thrive in a fast-paced environment

Ability to work well with a diverse team from various functions

Strong Microsoft Excel Skills

Excellent written and communication skills

About Replimune Replimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 with the mission to transform cancer treatment by pioneering the development of a novel portfolio of oncolytic immunotherapies. Replimune's proprietary RPx platform is based on a potent HSV-1 backbone intended to maximize immunogenic cell death and the induction of a systemic anti-tumor immune response. The RPx platform is designed to have a unique dual local and systemic activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to ignite a strong and durable systemic response. The RPx product candidates are expected to be synergistic with most established and experimental cancer treatment modalities, leading to the versatility to be developed alone or combined with a variety of other treatment options. For more information, please visit

We are an Equal Opportunity Employer.