Job Description
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 What You'll Do: - Ensures scientific and operational excellence across the toxicology and safety pharmacology activities.
- Collaborates closely with Nonclinical R&D Team, consultants, and external CRO partners to ensure studies are fit for purpose, completed on time, on budget and meet quality standards.
- Contribute to writing and editing nonclinical safety study research reports to support regulatory filing including pre-IND, IND, IND annual updates, IB, as well as relevant sections to support US and International regulatory filings.
- Track and manage timelines for Nonclinical R&D studies across various stakeholders identifying interdependencies, milestones, and risks.
- Align internal business needs and expectations with external CRO partners.
- Manage, setup, and maintain purchase orders in company purchasing systems.
- Ensure compliance with global non-clinical safety studies regulatory guidelines.
- Ensure completion of non-clinical safety studies to support program timelines and goals.
Qualifications What You'll Bring: - Ph.D. in Toxicology or related field and 5+ years of toxicology experience in the pharmaceutical industry.
- Experience in non-clinical safety assessment of small molecules from discovery through development.
- Demonstrated knowledge and full understanding of GLP regulatory requirements, Standard Operating Procedures (SOPs), company practices, and industry standards.
- Ability to apply project management principles including, but not limited to, identifying critical paths, building and communicating timelines, defining milestones and methods for setting expectations and accountability for deliverables within Non-Clinical R&D functions.
- Strong functional knowledge and experience of Toxicology, ADME/DMPK, Formulation & Analytical, and Bioanalytical workflows.
- Strong leadership competencies and management experience, including selecting CROs and overseeing the relationship.
- Excellent verbal and written communication, and organizational skills.
- Demonstrated independent analytical and problem-solving abilities.
- Excellent written and oral communication, presentation and influencing skills.
- Highly motivated, creative, and innovative, with a flexible, collaborative, team-oriented mindset, who solves problems in a goal-focused fashion.
Preferred Qualifications: - Experience in non-clinical safety assessment of small molecules from discovery through development.
- Experience managing CROs.
- Demonstrated knowledge and full understanding of GLP regulatory requirements, Standard Operating Procedures (SOPs), company practices, and industry standards.
Additional Information 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
- An annual lifestyle allowance
- 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
- [if applicable] Car allowance
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.
Job Tags
Temporary work, Summer work, Summer holiday, Flexible hours,