Senior Manager, Clinical Operations
Company DescriptionDeciphera 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.
Job DescriptionThe Senior Manager Clinical Operations will provide line management to Clinical Trial Coordinators (CTCs), Clinical Trial Associates (CTAs) and Senior CTAs and will develop robust and flexible methodologies to optimize and harmonize the administrative and operational support provided to the clinical trial teams.
What You'll Do:
Develop, mentor, manage and coach CTA staff to progress their skills so that Deciphera's quality standards are metEnsure CTA personnel work to the highest quality standards and maintain compliance with established SOPs, processes, project plans and all regulatory requirementsConduct onboarding training for new CTA staff in conjunction with the clinical trial teamDevelop robust and flexible operational methodologies, standards, and processes for the CTA role and ensure consistent, quality execution among the CTA personnelMay serve as a member of the clinical trial team and perform the job duties of Sr.
CTA or Study LeadFoster a highly collaborative culture and serves as a leadership role model within the company and with external stakeholdersDemonstrates excitement around the Vison and Mission of Deciphera and the departmentOther duties as assignedQualificationsBachelor's degree in health science or related fieldMinimum of 5 years in clinical trial managementExcellent communication (oral and written), organizational, and problem-solving skillsStrong attention to detailExpertise in clinical development process (Phase 1-3), global regulatory requirement, ICH guidelines, CGP and guidelines for clinical trialsExcellent leadership, interpersonal, communication, planning and organizational skillsPrior line management experience, preferredAdditional InformationWe 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.
We offer an outstanding culture and opportunity for personal and professional growth based on our PATHS Core Values:
Patients We are committed to improving the lives of patients living with cancer.
They are the driving force behind everything we do.
Accountability We demand accountability for our actions, behaviors, and performance.
We recognize our duty to maintain a culture that embraces the uniqueness of our people and finds strength in our differences.
Transparency We strive to provide full visibility to internal and external stakeholders for a complete picture of what we are doing and why.
Honesty and Integrity Trust and mutual respect are essential aspects of our culture.
We act with honesty and integrity in all facets of our business, and this serves as the foundation of our work and interactions with others.
Stewardship We are respectful of the resources entrusted to us by the investment community.
We act thoughtfully and allocate resources responsibly in seeking to create value for our shareholders.
How we work together and the behaviors that we show up with each day are critical to maintaining our positive culture.
Our behavioral expectations align with our values to elevate and drive individual and team performance:
Lead from where you are regardless of role or level, we motivate each other to achieve common goals.
Drive business results we navigate forward with our eye on the highest priorities.
Partner and collaborate we cultivate relationships and value ideas, regardless of where they are coming from, to achieve more together.
Continuously evolve and improve we try, we learn, we revise and try again.
Deciphera offers a comprehensive benefits package that includes but is not limited to the following:
Non-accrual paid time offSummer vacation bonusGlobal, company-wide summer and winter shutdownsAn annual lifestyle allowanceMonthly cell phone stipendInternal rewards and recognition programMedical, Dental, and Vision Insurance401(k) retirement plan with company matchLife and Supplemental life insurance for familyShort and Long Term Disability insuranceESPP offeringHealth savings account with company contributionFlexible spending account for either health care and/or dependent care.
Family planning benefitGenerous parental leave if applicable Car allowanceDeciphera (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.
EQUAL EMPLOYMENT OPPORTUNITY INFORMATIONDeciphera 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.
SummaryType:
Full-timeFunction:
ScienceExperience level:
Mid-Senior LevelIndustry:
Pharmaceuticals.
Estimated Salary: $20 to $28 per hour based on qualifications.
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.
Job DescriptionThe Senior Manager Clinical Operations will provide line management to Clinical Trial Coordinators (CTCs), Clinical Trial Associates (CTAs) and Senior CTAs and will develop robust and flexible methodologies to optimize and harmonize the administrative and operational support provided to the clinical trial teams.
What You'll Do:
Develop, mentor, manage and coach CTA staff to progress their skills so that Deciphera's quality standards are metEnsure CTA personnel work to the highest quality standards and maintain compliance with established SOPs, processes, project plans and all regulatory requirementsConduct onboarding training for new CTA staff in conjunction with the clinical trial teamDevelop robust and flexible operational methodologies, standards, and processes for the CTA role and ensure consistent, quality execution among the CTA personnelMay serve as a member of the clinical trial team and perform the job duties of Sr.
CTA or Study LeadFoster a highly collaborative culture and serves as a leadership role model within the company and with external stakeholdersDemonstrates excitement around the Vison and Mission of Deciphera and the departmentOther duties as assignedQualificationsBachelor's degree in health science or related fieldMinimum of 5 years in clinical trial managementExcellent communication (oral and written), organizational, and problem-solving skillsStrong attention to detailExpertise in clinical development process (Phase 1-3), global regulatory requirement, ICH guidelines, CGP and guidelines for clinical trialsExcellent leadership, interpersonal, communication, planning and organizational skillsPrior line management experience, preferredAdditional InformationWe 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.
We offer an outstanding culture and opportunity for personal and professional growth based on our PATHS Core Values:
Patients We are committed to improving the lives of patients living with cancer.
They are the driving force behind everything we do.
Accountability We demand accountability for our actions, behaviors, and performance.
We recognize our duty to maintain a culture that embraces the uniqueness of our people and finds strength in our differences.
Transparency We strive to provide full visibility to internal and external stakeholders for a complete picture of what we are doing and why.
Honesty and Integrity Trust and mutual respect are essential aspects of our culture.
We act with honesty and integrity in all facets of our business, and this serves as the foundation of our work and interactions with others.
Stewardship We are respectful of the resources entrusted to us by the investment community.
We act thoughtfully and allocate resources responsibly in seeking to create value for our shareholders.
How we work together and the behaviors that we show up with each day are critical to maintaining our positive culture.
Our behavioral expectations align with our values to elevate and drive individual and team performance:
Lead from where you are regardless of role or level, we motivate each other to achieve common goals.
Drive business results we navigate forward with our eye on the highest priorities.
Partner and collaborate we cultivate relationships and value ideas, regardless of where they are coming from, to achieve more together.
Continuously evolve and improve we try, we learn, we revise and try again.
Deciphera offers a comprehensive benefits package that includes but is not limited to the following:
Non-accrual paid time offSummer vacation bonusGlobal, company-wide summer and winter shutdownsAn annual lifestyle allowanceMonthly cell phone stipendInternal rewards and recognition programMedical, Dental, and Vision Insurance401(k) retirement plan with company matchLife and Supplemental life insurance for familyShort and Long Term Disability insuranceESPP offeringHealth savings account with company contributionFlexible spending account for either health care and/or dependent care.
Family planning benefitGenerous parental leave if applicable Car allowanceDeciphera (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.
EQUAL EMPLOYMENT OPPORTUNITY INFORMATIONDeciphera 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.
SummaryType:
Full-timeFunction:
ScienceExperience level:
Mid-Senior LevelIndustry:
Pharmaceuticals.
Estimated Salary: $20 to $28 per hour based on qualifications.
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