Associate Director, Regulatory Affairs

Company Description

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. 

Job Description

The Role:

The Associate/Director, Regulatory Affairs will join a group of highly motivated, top-notch regulatory professionals and will be a key player in shaping cohesive regulatory strategies across the product pipeline. 

The Associate/Director, Regulatory Affairs provides regulatory support for oncology products in early-stage and late-stage development through post approval.

This role will also serve as the regulatory lead for assigned projects and be responsible for applying regulatory expertise and experience to product development programs. 

Additionally, the Associate/Director is responsible for the oversight of clinical trial investigational new drug applications (INDs), clinical trial applications (CTAs) and marketing applications – i.e. biologics license applications (BLAs) and new drug applications (NDAs).

For more complex applications, this role will lead the finalization of regulatory submission documents and regulatory submissions for completeness and quality in global accordance with regulatory agency requirements, standards, and corporate practices.

This position will report to the Director of Regulatory Affairs.

What You’ll Do:

• Working as a regulatory lead to develop regulatory strategies for oncology development programs (which may range from FIH through post-marketing stage)
• Address complex issues by providing solid regulatory solutions and guidance to the cross-functional teams and senior management
• Monitor global regulatory changes that may impact asset development
• Provide tactical support and operational expertise with “hands on” support as needed
• Ensure compliance of regulatory strategies and submissions
• Assess project plans and timelines; manage staff effectively and collaboratively to ensure all projects are appropriately prioritized and key goals are met on time
• Contribute to the continuous improvement of existing department processes and create new processes to support the evolution of the company

Qualifications

What You’ll Bring:

Required Qualifications:

• B.S/M.S. and 8+ years of work experience in pharmaceutical regulatory affairs
• 5+ years of regulatory experience working with global development and submission plans
• Advanced knowledge and experience in interpretation of regulations, guidelines and precedents related to oncology drug development in the US and EU
• Must have experience filing INDs and/or NDAs and engagement with FDA and other regulatory bodies

Preferred Qualifications:

• Capable of strategic thinking and proposing innovative solutions to regulatory problems
• Demonstrates excellent verbal and written communication skills
• Experience managing a regulatory team

Additional Information

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.