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As part of Exelixis’ Phase I group, this role will be working within Clinical Operations where the employee manages clinical trials through operational planning, risk assessment and focuses on high quality deliverables. The employee will work with many groups within and outside of Exelixis to execute clinical trials, helping to bring meaningful products to market so that patients with cancer can recover stronger and live longer. Responsible for “field to table” operational conduct of GCP-compliant clinical trials, bringing high-quality data from field study sites to be included in statistical summary tables. Oversees internal and external staff for the timely and quality implementation of trials. Oversees Contract Research Organizations (CRO) activities. Coordinates the training of clinical and other staff.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Independently manage clinical trials via total site management, including those conducted through CROs
May hold the role of Study Execution Team (SET) Facilitator, and is responsible for the setting of agendas, effective facilitation of SET meetings, and the timely issuance and distribution of meeting minutes
Serves as primary contact for Exelixis functional area representatives and vendors and is responsible for protocol execution
Maintains regular internal contact with relevant departments such as Medical, Regulatory Affairs, Drug Safety, Clinical Supply, and others as necessary
Responsible for the day-to-day interaction with CROs and all study vendors in the execution of ongoing clinical trials
Assist with the development and review of study protocols, informed consent forms, case report forms, monitoring plans, study materials and monitoring tools
Establishes study milestones and ensures accurate tracking and reporting of study metrics to upper management
Perform CRO oversight activities such as Trip Report Review, TMF review and co-monitoring visits, per Study Plans. Provide written documentation of all activities including issues and findings in Spreadsheets or databases
Co-monitor clinical study sites up to 25% of travel; write and review reports for PSSVs, SIVs, IMVs, and COVs as required
Assist in the management of external vendors (e.g. clinical labs, study assessment labs)
Perform country and site operational feasibility assessments for new clinical protocols
Support efforts geared to prepare clinical sites for regulatory inspection readiness
Help identify and recruit clinical investigators
Review sample, investigator-prepared and IRB-approved informed consents
Coordinate the design, format and content of study guides and subject instructions
Coordinate the activities associated with site start-up and management (globally)
Coordinate the arrangements and tracking for investigational product
Coordinate the preparation, conduct and presentations at Investigator Meetings
Manages the overall Investigational product accountability and reconciliation process
Coordinate CRO tracking, and training, including central laboratories
Provide study-specific outsourcing specifications for Request For Proposals
Coordinate CRO relationships and performance
Ensure compliance with Exelixis’ SOPs, policies, and procedures.
Assist in the preparation of Clinical Study Reports, Annual IND safety reports and clinical summaries, as required.
Monitor clinical sites for adherence to protocol and GCP reporting any protocol deviations
With the appropriate competency and skills, may supervise staff, assign work, and perform performance appraisals
Experience in starting a study up, closing out a study, and working on the maintenance phase of study
SUPERVISORY RESPONSIBILITIES:
None
EDUCATION/EXPERIENCE/SKILLS:
Education:
BA/BA in biological sciences or related field, or BSN, MS, MSN, PharmD or MPH
Experience:
Typically requires a minimum of 9 years of related experience in life sciences, including 7 years in experience in clinical research and at least 4 years of study management
Knowledge/Skills/Abilities:
Proven ability to provide clinical expertise to a clinical development program
Proficiency in clinical studies involving complex design
Experience in independent preparation and review of clinical sections of IND, BLA, or NDA reports
Experience with management of multinational clinical trials
Demonstrated matrix leadership skills.
Detailed knowledge of FDA GCP/ICH regulations and guidelines
Ability to anticipate and resolve problems and drive to results
Ability to write and present clearly especially on scientific and clinical issues
Ability to work effectively in a team/matrix environment
Excellent interpersonal, organizational, supervisory and project planning skills.
Demonstrated professional collaboration skills
Experience in all phases of drug development, including international trials
JOB COMPLEXITY:
Impacts the results of a department or a project influencing both the tactical work and the direction of future endeavors for the group.
Responsible for ensuring achievement of own or others’ revenue targets.
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DISCLAIMER
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.
