Deciphera Waltham , MA 02154
Posted 2 days ago
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
We are seeking a Clinical Trial Associate (CTA) to assist and provide support to the members of the clinical operations project team in order to facilitate the management of the clinical trial processes, including planning and execution of clinical trials. The CTA assists in supporting the conduct of trials and may be responsible for managing specific study and operational tasks.
What You'll Do:
Maintain study trackers and tools as directed by the CPM
Support site start-up activities
Assist study team with preparation for audits/inspections
Assist in creating, editing, and distributing informed consent templates, manuals and other study documents
Track 1572s and liase with Regulatory for IND submission as well as other essential documents as appropriate
Perform Trial Master File (TMF) QC
Perform quality control review of documents
Assist with sample management
May provide study-specific training and mentoring to CRAs and site staff
May develop and maintain study documents
May participate in review of study core documents (protocol, IB, CSR)
Demonstrates excitement around the Vison and Mission of Deciphera and the department
Other duties as assigned
Qualifications
What You'll Bring:
Bachelor's degree
1+ years of hands on clinical research experience either at an academic center, CRO or Pharmaceutical/Biotech company
Excellent communication (oral and written), organizational, and problem-solving skills
Strong attention to detail
Excellent Microsoft Office skills
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
ESPP offering
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
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.
Deciphera