Every Exelixis employee is united in an ambitious cause: to launch innovative medicines that give patients and their families hope for the future. In this pursuit, we know our employees are our most valuable asset. After operating in the challenging biotech sector for 25 years, we have a proven track record of resiliency in the face of adversity. The success of our lead product has provided a solid commercial foundation allowing us to reinvigorate our research efforts, and grow our team in areas such as Drug Discovery, Clinical Development and Commercial.
As we expand our global partnerships and further reinvest in R&D to help us discover the next breakthrough for difficult-to-treat cancers, we’re seeking to add talented, dedicated employees to power our mission.
Cancer is our cause. Make it yours, too.
Provides study management expertise. Coordinates the activities associated with the management of clinical trials, including CRO oversight, to achieve study deliverables. Facilitates the training of staff involved in study management.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Responsible for the day-to-day interaction with Contract Research Organization (CRO) in the management and execution of the ongoing clinical study
• Perform CRO oversight activities such as monitoring trip report review and TMF review per Study Plans.
• Support the CRO in the management of clinical sites for preparations for regulatory inspections, evaluates critical protocol deviations, resolve site issues, and maintain good relations with physicians and clinical site staff
• Ensures that study milestones are met as well as accurate tracking and reporting of study metrics
• Maintain regular internal contact with relevant departments such as Regulatory Affairs, Drug Safety, and others as necessary
• Ensure compliance with GCP, regulatory, and Exelixis' policies and procedures.
• No supervisory responsibilities
EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
• BA/BA/BSN in biological sciences or related field and seven years of related experience; or,
• MS/MA/MSN in biological sciences or related field and five years of related experience; or,
• PhD/PharmD in biological sciences or related field and zero to two years of related experience; or,
• Equivalent combination of education and experience.
• Typically requires a minimum of 7 years of related experience in life sciences/clinical research, including 5 years in experience in clinical operations role at sponsor or CRO
• Minimum of 2 years in Oncology Therapeutic Area
• Global Phase 3 trials, conduct though closeout
• Experience in study conduct and close out
• Familiar with advanced concepts of clinical research
• Ability to deal with time demands, incomplete information or unexpected events
• Experience in interactions with outside vendors, e.g., CROs and contract labs
• Proficient in performing TMF quality reviews and knowledge of eTMF systems are desirable
• Experience managing global clinical trials is strongly preferred
• Experience with data review, listings review, and logic checks
• Demonstrated ability to write and present clearly using on scientific and clinical issues terminology
• Advanced computer skills especially with Microsoft Excel
• Good organizational and planning skills
• Strong interpersonal skills and communication skills (both written and oral)
• Ability to work effectively in a team/matrix environment; understand technical, scientific and medical information; and problem-solve
• Environment: primarily working indoors, performing clerical work
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.
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