Senior Manager, IRT Supply Chain Systems

Senior Manager, IRT Supply Chain Systems

• Full-time
• Work Type: Full time
• Job Location: On-Site Waltham

Deciphera, a member of ONO, is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative medicines.

Enabled by our proprietary drug discovery platform, Deciphera has developed a diverse pipeline of wholly-owned drug candidates. QINLOCK (ripretinib) is Deciphera’s switch control inhibitor developed for the treatment of fourth-line GIST. QINLOCK is approved in multiple regions including Australia, Canada, China, the European Union, Hong Kong, Switzerland, Taiwan, the United States, and the United Kingdom. We wholly own QINLOCK and all of our drug candidates with the exception of a development and commercialization out-license agreement for QINLOCK in Greater China. In addition to QINLOCK, we have identified and advanced multiple product candidates from our platform into clinical studies, including vimseltinib and DCC-3116.

We offer an outstanding culture and opportunity for personal and professional growth guided by our “PATHS” Core Values and how we work together. We are proud to be Great Place to Work Certified 2023 and rank #25 on Fortune’s Best Places to Work Small and Midsized Biotech Companies in 2023.

We are seeking a Manager/Senior Manager in IRT Systems , who will be responsible for managing Clinical IRT Systems, forecast tools and services and will serve as an expert resource in supply for multiple global clinical trials and the Systems Analyst, collaborating with Clinical Operations, Information Technologies and Quality Systems in the selection, implementation, and maintenance of GMP/GCP systems. This role is responsible for demand planning for clinical supplies. This position will report to the Associate Director, Supply Chain Systems and is located in the Waltham, MA office or can be remote.

What You’ll Do:

• Serve as subject matter expert for the cross-functional team on best practices for all aspects of IRT
• Facilitate discussions concerning IRT design between Deciphera study team and IRT vendor
• Ensure IRT specification and service meet protocol requirements and study team needs
• Create and drive IRT related timelines and deliverables
• Partner with IRT vendor to organize reoccurring post-live meetings with study team
• Create and provide IRT related trainings for appropriate team members
• Assess and iterate IRT process structure
• Formalize IRT standards based on input from study team stakeholders
• Suggest improvements to quality procedures and best practices
• Support Clinical Supply Project Managers in developing resupply algorithms to be used in IRT to maximize use of available inventory
• Collaborate with Clinical Supply and Clinical Operations to understand study design, dosing and initial and resupply clinical supply requirements
• Help lead URS and UAT set-up in conjunction with IRT Vendor, Clinical Supply and Clinical Operations
• Work with IRT Vendor, Biostats, Clinical Operations and/or CRO to obtain randomization input into system (if applicable) and/or unit serialization for open-label studies
• Assist stakeholders with IRT day to day operations, including but not limited to depot setup, supply strategies, country and lot input/releases, manual shipments, expiry date management, and inventory levels
• Troubleshoot IRT issues and provide timely resolution during the conduct of the clinical studies
• Manage Forecast / Demand Planning

What You’ll Bring:

• AD/BA in Scientific or related field or equivalent with 3+ years of IRT management experience including systems such as EDC and eTMF experience.
• Working knowledge of FDA regulations related to New Drug Applications, Good Manufacturing Practices, Good Clinical Practices as well as Microsoft Office, Word, Excel and PowerPoint required.
• Prior experience working with multiple Clinical Information Systems simultaneously along with general knowledge of FDA and other global clinical trial regulations, as well as detailed knowledge of ICH and FDA GCP guidelines.

Additional Qualifications:

• High attention to detail and demonstrated ability to manage multiple critical path projects concurrently.
• Demonstrates flexibility adapting to external environment influences through development of new strategies and tactics.
• Good organization and project management skills with a demonstrated ability to work independently, take initiative, complete tasks to deadlines.
• Ability to communicate effectively with external vendors, including issue escalation, and responding to inquiries and concerns.
• Able to work in a fast-paced environment with demonstrated ability to prioritize multiple competing tasks.
• Ability to identify and resolve issues.

Deciphera offers a comprehensive benefits package that includes but is not limited to the following:

• Non-accrual paid time off
• Summer vacation bonus
• Global, company-wide summer and winter shutdowns
• Monthly cell phone stipend
• Internal rewards and recognition program
• Medical, Dental, and Vision Insurance
• 401(k) retirement plan with company match
• Life and Supplemental life insurance for family
• Short and Long Term Disability insurance
• Health savings account with company contribution
• Flexible spending account for either health care and/or dependent care.
• Family planning benefit
• Generous parental leave

Deciphera, a member of ONO, is a company headquartered in Waltham, Massachusetts. Our state-of-the-art research facility is located in Lawrence, Kansas and our European operations are run out of Switzerland.

EQUAL EMPLOYMENT OPPORTUNITY INFORMATION

Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements and to learn more about how we can increase diversity in our candidate pool, we invite you to voluntarily provide demographic information in a confidential survey at the end of this application. Providing this information is optional. It will not be accessible or used in the hiring process, and has no effect on your opportunity for employment. This information will also be treated confidentially. Our commitment to increasing diversity in our candidate pool does not affect our commitment to equal employment opportunity, including our ongoing commitment to make all hiring and other employment decisions solely on a nondiscriminatory basis.