Merrimack is a fully integrated biopharmaceutical company that views cancer as a complex engineering challenge. Through systems biology, which brings together the fields of biology, computing and engineering, Merrimack aims to decrease uncertainty in drug development and clinical validation, and move discovery efforts beyond trial and error. Such an approach has the potential to make individualized treatment of patients a reality. With five candidates in clinical trials, several in preclinical development and multiple biomarkers designed to support patient selection, Merrimack is building one of the most robust oncology pipelines in the industry. Merrimack has a New Drug Application under review for its lead product candidate, MM-398, for the treatment of patients with metastatic adenocarcinoma of the pancreas who have been previously treated with gemcitabine-based therapy. For more information, please visit Merrimack's website at www.merrimack.com or connect on Twitter at @MerrimackPharma.
We are looking for a talented Clinical Supply Manager to join our team in Cambridge!
Job Responsibilities:
Work closely with Clinical Operations to monitor and track clinical trial enrollment plans and actual enrollment
Collaborate with Clinical Trial Managers, clinical packaging sites, applicable internal Merrimack functional areas, CROs, and others as applicable to evaluate and maintain up-to-date status records and reporting for all clinical supply-related activities across projects / products
Develop, manage, and utilize appropriate inventory reporting tool(s), including Oracle, for maintaining clinical supply inventory and forecast records
Manage communication and review process for recommended clinical packaging plans
Communicate clinical packaging plans to applicable contract packaging sites, and ensure effective management of clinical packaging site activities
Develop and maintain information and reporting, in collaboration with Regulatory Affairs and Quality Assurance, to ensure alignment of regulatory filing status and Quality disposition status with availability of appropriate clinical trial inventory
Develop and maintain information and reporting, in collaboration with Quality Control, to ensure transparency of project / product current expiry periods, and plans for expiry extension
Collaborate with Supply Chain Planning to develop and manage routine Supply & Ops Planning meeting for clinical projects / products
Collaborate with Supply Chain External Supply to develop and maintain reporting of end-to-end supply chain status for clinical trial inventory, inclusive of logistical activities
Assist is coordinating and monitoring change control activities relative to clinical trial products
Develop and maintain a master clinical trial inventory tracking report
Collaborate with Clinical Operations, packaging CROs, Merrimack QA and regulatory agencies to develop regulatory compliant labels for finished product
Assess, manage, and track the purchase, distribution and labeling of comparator products and other miscellaneous ancillary clinical trial material
Collaborate with Clinical Trail Managers to develop the drug distribution strategy for each trial and lead the development, review and acceptance testing of IVRS when applicable
Monitor and report on clinical supply inventory for each project / product
Manage and track inventory at site level and place manual orders as needed
Develop and maintain applicable metrics to monitor performance relative to clinical trial inventory and planning
Other duties and activities as defined by management to enhance management of clinical trial inventory
Collaborate with Clinical Trial Managers and Project Leads to both gather project / product clinical trial forecast requirements and demand history data, and generate / revise clinical trial inventory forecast requirements for planning purposes
Collaborate with Clinical Operations to identify demand assumptions, such as enrollment rate, number of sites, number of countries, etc.
Collaborate with Supply Chain Planning to ensure that clinical supply inventory and forecast information is included in the integrated planning process
Requirements:
Bachelor’s degree in an applicable discipline
7 - 10 years clinical supply management or equivalent experience in the pharmaceutical / biopharmaceutical industry
Strong background in working within ERP systems, preferably Oracle
Ability to communicate effectively both orally and in writing both within Merrimack, and with external vendors and partners
Ability to work both independently, and in a team environment
Ability to work in a fast paced and dynamic environment
Strong working knowledge of standard business software, including MS Excel, Word, and PowerPoint
Strong analytical and organizational skills
Minor travel may be required, up to 10%
To apply please go to: https://app.jobvite.com/j?cj=osrO1fws&s=Mass_Biotech_Council