Director, Global Clinical Supply

Company Profile:

At Verastem Oncology, our purpose is to create a world where no cancer patient ever runs out of options. This commitment is central to who we are as a company and the culture we nurture. We are laser focused in our efforts to establish avutometinib + defactinib as the backbone of therapy for RAS-mediated tumors. We look for people who share our perspective; when others see only a problem, we see an opportunity, when others give up, we step up. We partner with global leaders (and their teams!) and these relationships help us to serve the patients who need us most. We appreciate your candidacy for the Verastem Oncology team and encourage you to learn more at www.verastem.com.

Summary:

As the Director, Global Clinical Supply, you will have ownership and oversight of all aspects of the clinical supply chain to ensure uninterrupted and timely clinical drug supply for Verastem's clinical programs and IST relationships. This will include supply chain development, global inventory management, oversight of label development, package manufacturing, and finished product logistics. This incumbent will further work closely with the Clinical Operations team members to develop clinical study forecasts and build aggregate demand for clinical programs as well as work across multiple disciplines to help meet corporate objectives and maintain KPIs and performance metrics for Verastem's clinical programs.

Responsibilities:

• Manage clinical forecast plans and budgets related to drug product and clinical supplies for multiple programs and study levels, based on clinical study protocol and clinical development plans.

• Contribute to maintenance of CMO landscape and outsourcing strategy for Global Clinical Drug Supply Operations including acting as Vendor Relationship Manager of selected CMOs.

• Work closely with external and internal partners relating to sourcing and management of comparator drugs for both domestic and international trials.

• Provide leadership over the comparator sourcing strategy and timing of delivery management.

• Oversee the labeling, packaging, release, distribution and returns of clinical supplies at external CMOs for the assigned studies, maintaining budget, and ensuring that the projects are delivered on time and ensuring uninterrupted supply.

• Create global supply strategies, supply plans to support clinical studies; collaborate with CMC, Clinical Operations, Regulatory Affairs, Quality Assurance, and external vendors to execute the strategies for the clinical studies.

• Manage label development process from generation of the master label text to label printing.

• Lead the development, review, and User Acceptance Testing (UAT) of the Interactive Response Technology (IRT) system.

• Co-lead the development of pharmacy documents, manuals, and other tools with Clinical Operation team.

• Represent Clinical Supply's function at clinical trial team meetings; communicate plans and timelines to internal and external customers and partners.

• Proactively addressing risk management issues and implementing business continuity plans. Provide coaching and guidance to team members.

Education/Experience/Knowledge & Skills:

• Bachelor's degree in biotechnology, supply chain, or related scientific discipline.

• 8-10 years of clinical supply management. Excellent knowledge of demand and supply planning.

• Experience with Excel, SmartSheets, Oracle or similar systems.

• Proficient in quality event documentation practices and Veeva QMS.

• Understanding of CMC, GMPs, quality, clinical operations, and IRT/IWRS systems.

• Working knowledge of cGXP's and pharmaceutical industry procedures and regulations.

• Working knowledge of import and export requirements in a regulated environment.

• Experience participating in cross functional teams such as CMC/Clinical Operations teams.

• Experience interfacing with internal operations groups and/or contract manufacturing organizations on early and late phase clinical trials.

• Independent, self-motivated individual with the ability to manage change through influence.

• Ability to solicit input, obtain stakeholder buy-in and build cross-functional consensus.

• Experience in building new processes and establishing standards.

• Strong problem-solving and decision-making skills.

• Strong interpersonal skills and works effectively as part of a team.

• Exceptional verbal and written communication skills.

• Travel: approximately 20%.