Senior Scientist II, Toxicology and Toxicology Program Management Job at Deciphera Pharmaceuticals, Waltham, MA

SkJqZEhGeURySi93L1R1by9nSGJPclcvWkE9PQ==
  • Deciphera Pharmaceuticals
  • Waltham, MA

Job 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

Full time, Temporary work, Summer work, Summer holiday, Flexible hours,

Similar Jobs

Headway

LP (Remote) Job at Headway

 ...clients you see through Headway, so that you can set the hours that work for you. Grow your caseload by providing marketing support and...  ...patients in-person or remotely via telehealth while working from home. We accept the following licenses on a state by state basis:... 

JACK SPRAT

COOKING AND SERVING Job at JACK SPRAT

 ...dinner 5 nights per week and see a good mix of locals and tourists. Our scratch kitchen is known for healthy alternatives featuring vegan fare, Alaskan seafood, all-natural meats, and decadent desserts. We promote a progressive tip share that rewards all non-management... 

Headway

LP (Virtual) Job at Headway

 ...Remote Licensed Psychiatrist Wage: Between $148-$232 an hour Are you a licensed Psychiatrist looking to launch a private practice, or grow your existing practice? Headway can help you earn more through insurance! Headway supports thousands of mental health... 

VIDA Diagnostics Inc

Principal Data Platform Engineer Job at VIDA Diagnostics Inc

: As the Principal Data Platform Engineer, you will play a crucial role in our dynamic team, responsible for designing, developing, and optimizing data platforms and algorithms that drive groundbreaking insights in the field of medical research. You will work in close ...

Yiwen Kindergarten

ESL Teacher / Homeroom Teacher Job at Yiwen Kindergarten

:We are looking for a passionate and creative English teacher to join our kindergarten team. The ideal candidate should have excellent English teaching skills and be able to engage young children in learning English through lively and interesting methods.Main Responsibilities...