Director, Clinical Operations

Deciphera 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.

In addition to advancing multiple product candidates from our platform in clinical studies, QINLOCK® is Deciphera’s FDA-approved switch-control kinase inhibitor for the treatment of fourth-line gastrointestinal stromal tumor (GIST). QINLOCK is also approved for fourth-line GIST in Australia, Canada, China, and Hong Kong.

Deciphera (NASDAQ: DCPH) is a publicly traded 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. 

We offer an outstanding culture and opportunity for personal and professional growth based on our “PATHS” Core Values:

• Patients – places the importance of improving the lives of patients and their caregivers at the forefront of every day’s work.
• Accountability – for our performance and the way we work with coworkers and other stakeholders.
• Transparency – in our intent and actions to both internal and external stakeholders.
• Honesty and Integrity – fosters trust and strives to deliver on our and the company’s promises.
• Stewardship – values and uses wisely the resources and investments provided to the company.

The Director, Clinical Operations will ensure that clinical stage programs achieve program objectives within established timelines, budget, and quality standards. 

What You’ll Do:

• Contributes to the development of clinical program strategy and executes on that strategy
• Accountable for results of clinical trials under their program
• Provide leadership and direct line management to clinical operations team
• Emphasis will be on superior execution, transparency within the department and to Senior Management, and ability to employ cost effective measures and stewardship relative to clinical trial cost projections and final accounting for company
• Lead and direct the clinical operations team responsible for management and execution of all clinical trials
• Provide strategic and technical guidance to ensure that clinical trials are properly defined, planned and executed
• Assist in the authoring of key regulatory documents (e.g., CTD, pre-meeting materials and briefing packages), study protocols, investigator's brochures, annual IND progress reports, study postings, and CSR for consistency across programs
• Develop in-depth knowledge of the clinical data and assures appropriate transfer of that knowledge to cross-functional study teams to achieve operational excellence
• Ensure that study objectives are in line with the clinical development strategy and the overall corporate goals
• Ensure external vendors are selected and managed to deliver within established timelines and budget
• Support the creation of clinical operations Standard Operating Procedures (SOPs), systems, and processes across the trials; ensures compliance with regulatory and other applicable standards and guidelines
• Foster a highly collaborative culture and serves as a leadership role model within the company and with external stakeholders
• Demonstrates excitement around the Vison and Mission of Deciphera and the department
• Other duties as assigned

• Bachelor’s degree in health science or related field
• Minimum of 10 years in clinical trial management
• Excellent communication (oral and written), organizational, and problem-solving skills
• Strong attention to detail
• Expertise 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

What Deciphera will Bring: 

Deciphera offers competitive compensation, including equity-based compensation, and a comprehensive benefits package that includes 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

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.