Senior Clinical Trials Manager at Exelixis, Inc. in Alameda, California

Job Description:

Company Description

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.

Position Description:

Plans and manages clinical trials. Oversees internal and external staff for the timely and quality implementation of trials. Oversees CRO activities. Coordinates the training of clinical and other staff. Performs performance appraisals on direct reports.

Position Requirements:

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Independently manage clinical trials, including those conducted through Contract Research Organizations
• May hold the role of Study Team (ST) Facilitator, and is responsible for the setting of agendas, effective facilitation of ST 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 Regulatory Affairs, Drug Safety, and others as necessary
• Responsible for the day-to-day interaction with CROs in the execution of ongoing clinical trials
• May 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
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 operational feasibility assessments for new clinical protocols
• Support efforts geared to prepare clinical sites for regulatory inspections
• 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
• Coordinate the arrangements for investigational product
• May 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 RFPs
• Coordinate CRO relationships and performance
• Ensure compliance with Exelixis's policies and procedures.
• May assist in the preparation of Clinical Study Reports, Annual IND safety reports and clinical summaries, as required.
• May monitor clinical sites for adherence to protocol and GCP
• With the appropriate competency and skills, may supervise staff, assign work and perform performance appraisals Experience in either starting a study up, closing out a study, or 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 of clinical sections of IND, BLA, or NDA
• Experience with management of multinational clinical trials
• Demonstrated matrix leadership skills.
• Detailed knowledge of regulations and guidelines • Ability to anticipate and resolve problems
• 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
• Proficiency in the preparation and review of clinical sections of study reports and BLA/NDA
• 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.