Job Description
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
The Role :
The Associate Director, Clinical Operations is responsible for the successful execution of clinical trials from protocol conception through the clinical study report.
The Senior Clinical Project Manager ensures completion of study deliverables and proactively identifies and resolves clinical project issues.
What You’ll Do :
- Demonstrated leadership in the planning, execution and completion of clinical trials
- Proactively identifies and resolves operational issues / processes to ensure achievement of study milestones, data quality and date integrity
- Accountable for oversight of the setup, maintenance, and close out of the Trial Master File
- Interacts with and participates in strategy discussions with other functional areas to support clinical trial activities
- Participates in the selection and oversight of CROs and vendors
- Responsible for assuring compliance with internal SOPs, FDA regulations and GCP
- May participate in the preparation, review, updating and training of SOPs
- Assist in the creation and management of program level budget with Director, Clinical Operations
- May contribute to the strategic development of the program
- Support / may lead department initiatives and process improvements
- Present on-going study updates to Clinical Leadership
- Serve as a leadership role model within the clinical operations department
- Demonstrates excitement around the Vison and Mission of Deciphera and the clinical operations department
- Other duties as assigned
Qualifications
What you'll Bring :
- Bachelor’s degree in health science or related field
- Minimum of 8 years in clinical trial management
- Excellent communication (oral and written), organizational, and problem-solving skills
- Strong attention to detail
- Comprehensive knowledge in clinical development process (Phase 1-3), global regulatory requirement, ICH guidelines, CGP and guidelines for clinical trials
- Extensive CRO / vendor management experience
- Excellent leadership, interpersonal, communication, planning and organizational skills
- Demonstrated ability to identify and resolve issues
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.
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