Associate Director, Clinical Data Management

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

Exciting time to be joining Deciphera as we continue to build an amazing Clinical Data Management Team. Come join our dedicated and forward-thinking DM group as we embrace innovative technologies and processes in this evolving industry. We are seeking an Associate Director of CDM to lead clinical data management activities across one or more clinical programs or therapeutic areas within the portfolio. This position will report to the Director or Sr. Director Head, of Clinical Data Management.

What You'll Do:

• Ensure the data quality and data integrity for highly complex or pivotal clinical studies
• May manage escalations and ensure that optimal relationships are developed with the outsourced CDM vendor
• May help select and manage CDM vendors and ensure their performance is consistent with Deciphera standards
• May review and approve invoices
• Forecast timelines and resources required to complete study-specific tasks on time and with high quality
• Work collaboratively with stakeholders in Medical Affairs, Regulatory, PV to determine dates of program data deliverables
• Provide expert CDM guidance to study teams, vendors and management
• Resolve complex technical or procedural issues and manage the escalation of issues
• Communicate issues and ongoing study and program updates to management
• May oversee and develop team of CDM staff
• May identify and evaluate modern technology and propose to management
• May contribute to projects involving standard ways of collecting and harmonizing clinical trial data, such as standard eCRFs, standard validation checks and conventions
• Ensure CDM activities are executed in accordance with all relevant SOPs and study plans
• Ensure CDM documentation is filed according to SOPs and the study plans
• Support inspection activities and manage any findings to resolution
• Participate in the development and revision of Standard Operating Procedures (SOPs)
• Define metrics to measure clinical trial database quality, site and vendor performance and implement those metrics in the clinical trials
• May propose and define Key Risk Indicators (KRIs) and Quality Threshold Limits (QTLs) related to clinical trial data and sites.
• Analyze metrics across projects and programs; escalate or inform management and cross functional colleagues to trends
• Facilitate resolution of operational problems, issues, obstacles and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders
• Assist with development of therapeutic area standards for Case Report Forms and Edit Checks
• Function as the CDM subject matter expert for process related questions from other Clinical Data Managers, cross functional colleagues and business improvement teams

Qualifications

What You’ll Bring:

• Bachelor’s or master’s degree, plus 12+ years of experience; or PhD or equivalent plus 8+ years of experience

• Knowledge of clinical trial design and analysis activities and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP), CDISC standards and eCTD submission requirements
• Excellent communication and critical thinking skills
• Ex