Clinical Supply Chain Senior Manager - Deciphera Pharmaceuticals

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 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.  

See here for more details on our portfolio.

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. Find more details about our award-winning culture here. 

Deciphera Pharmaceuticals is seeking a Clinical Supply Chain (Senior) Manager to join our growing team.  This individual will consistently demonstrate our PATHS Values and also manage day-to-day clinical supply chain activities to support Deciphera’s clinical programs.  This involves translating clinical study information into a demand plan, managing clinical trial material inventory at third-party vendors, and maintaining essential documents.  The Clinical Supply Chain (Senior) Manager serves as the primary supply chain lead for assigned clinical programs.

The position requires flexibility, teamwork, attention to detail, and rapid response to issues as they arise.  Strong cross-functional team leadership and project management skills are essential requirements.

This is an individual contributor role which will report to the Associate Director, Clinical Supply Chain, and be located in the Waltham, MA office or remote.

What You'll Do: 

• Serve as the Clinical Supply Chain lead for assigned studies and develop the clinical supply plan (i.e., packaging strategies, timelines, and budgets) including creating complex study forecasts with input from Technical Operations, Clinical, and Regulatory.
• Author, review, and/or approve relevant clinical and technical documents, including but not limited to label text, batch record, clinical trial protocol, and pharmacy manual.
• IRT set-up and maintenance for Clinical Supply Chain activities including supply-related input and review of the URS, performing UAT, and overseeing supply-related changes.
• Coordinate primary and secondary packaging, labeling, distribution, return and destruction activities with third-party vendors.
• Facilitate the process for final drug release.
• Ensure uninterrupted supply availability throughout the duration of a clinical study program.
• Work with Quality and Regulatory to develop CTM label text, regulatory review, and translation activities.
• Proactive and continuous risk management of the end-to-end clinical supply chain (inventory management, shelf life, country approvals, etc.).
• Manage the study finances (purchase orders, change orders) and ensure accurate and timely payment of invoices.

What You'll Bring: 

• 3+ years’ experience in the pharmaceutical industry.
• Understanding of clinical trial supply chain processes, including demand forecasting, planning, sourcing, and distribution.
• Working knowledge of relevant regulations, guidelines, and standards governing clinical supply chain operations, such as Good Manufacturing Practice (GMP).
• Problem-solving and analytical skills, with the ability to make sound decisions in complex and time-sensitive situations.
• Strong communication and interpersonal skills, with the ability to collaborate effectively across functions and regions and influence key stakeholders.
• Detail-oriented mindset with a focus on quality, compliance, and prioritization.
• Team player.

Deciphera offers competitive compensation and a comprehensive benefits package that includes the following:

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

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.