Senior Clinical Project Manager - #134925

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 Senior Clinical Project Manager 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:

• Represents and leads the study team to design, develop and deliver the study to agreed upon timelines
• Leads the planning and communication with cross functional teams to ensure proper execution and conduct of the clinical trials
• Provides oversight and management of CROs and vendors
• Oversees and monitors the management of clinical studies ensuring they are conducted in compliance with agreed upon study plans through regular CRO and/or investigator site contact
• Monitors progress of clinical activity and reports on progress of assigned clinical trials including budget and timelines
• Monitors status of clinical data collection of assigned clinical trials
• Prepares potential investigator site lists and assists with their evaluation for inclusion in the study
• Develops study-related documents
• Reviews and approves study-related plans generated by CROs, vendors and ensures the documentation are in accordance with GCP, regulatory requirements and consistent with the protocol
• Assist study team with preparation for audits/inspections
• Participates in the review and finalization of clinical study-related documents such as protocols, protocol amendments, and CSRs
• Prepare and deliver program/study updates
• Manages escalation of study related issues and communicates as appropriate to management
• Ability to anticipate potential study issues and to prepare contingency plans with minimal oversight
• Present on-going study updates to Clinical Leadership
• Contributes to development of RFPs and participate in selection of CROs/vendors
• Evaluates issues found in clinical studies, communication and oversight of CROs and vendors, and suggests and implements solutions and mitigations as required
• Provides oversight for the setup, maintenance, and close out of the Trial Master File and ensures it is complete and inspection ready
• Responsible for assuring compliance with internal SOPs, FDA regulations and GCP
• Provide input as the subject matter expert for assigned studies during regulatory inspections
• Mentor other clinical operation team members and may have direct reports
• May simultaneously lead/manage more than one clinical trial
• 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 5 years in clinical trial management
• Excellent communication (oral and written), organizational, and problem-solving skills
• Working knowledge of ICH guidelines, GCP, and current global regulatory requirements and guidelines for clinical trials
• Strong experience facilitating project team meetings, cross-functional team communication and decision making and ensuring alignment with stakeholders

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.