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Key Responsibilities:
- Regulatory lead for assigned oncology programs, developing and implementing innovative regulatory strategies from FIH through post-marketing stages.
- Provide regulatory input to clinical and development teams to ensure strategic alignment across functions.
- Monitor and interpret global regulatory trends and communicate potential impact on programs to senior leadership.
Qualifications:
- B.S. or M.S. in a scientific discipline and a minimum of 12 years of experience in pharmaceutical Regulatory Affairs.
- Advanced knowledge and experience interpreting regulations, guidelines, and precedents related to oncology drug development in the US and EU.
- Proven track record in preparing and submitting INDs, NDAs, and other major regulatory filings.
Preferred Capabilities:
- Strategic thinker with the ability to anticipate regulatory challenges and propose innovative solutions.
- Experience working in oncology drug development at a small-to-midsize biotechnology company.
- Strong leadership and mentorship skills with a collaborative approach.
Additional Information:
- Competitive salary and annual bonus.
- Comprehensive benefits package including medical, dental, vision insurance, 401(k) retirement plan with company match, and more.
- Generous parental leave and family planning benefits.
Deciphera
Deciphera is a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines for cancer, neurologic and autoimmune disease. They cultivate an inclusive culture that values curiosity, creativity, and shared accountability, empowering individuals to challenge the unknown together.