Clinical Trials Manager (Biotechnology / Oncology)

SUMMARY / JOB PURPOSE :

The Clinical Trials Manager (CTM), Clinical Operations, coordinates the activities associated with the evaluation, initiation, and management of clinical trials. This position is responsible for overseeing the execution of clinical trials, collaborating with cross-functional teams, performing oversight activities of Contract Research Organizations (CROs), and providing operational support to the Study Delivery Lead (SDL).

ESSENTIAL DUTIES AND RESPONSIBILITIES :

• Manages clinical trials, including those conducted through Contract Research Organizations (CROs)
• May participate in developing and recommending operational strategies for clinical trials in collaboration with cross-functional teams
• Responsible for at least one geographical region and manages / oversees one to three external vendors within a specific scope (e.g., Lab)
• Engages with CROs, vendors and sites for ongoing trial execution, including relationship management and quality / performance oversight
• Provides CRO oversight on activities related to site start-up and maintenance, including reviewing trip reports, protocol deviations, data review, etc.
• Attends and contributes to internal Study Delivery Team (SDT) meetings, including contribution to agenda preparation
• Coordinates the preparation, conduct, and presentations at Investigator Meetings
• Assists Study Delivery Team (SDT) and CRO in feasibility assessments and site selection
• Assists with study protocol development, reviewing of informed consent forms, case report forms, monitoring plans, and other study materials
• Maintains regular contact with relevant departments (e.g., Regulatory Affairs, Drug Safety, Clinical Supplies, Data Management, etc.)
• Provides oversight to CRO to ensure site adherence to protocol and Good Clinical Practice (GCP) guidelines
• Proactively identifies and communicates study issues, provides risk mitigation strategies, and escalates issues as needed
• Provides support for adherence / compliance to study plans (e.g., Verification of Performance (VOP)
• Ensures oversight of regulatory and essential documents
• Supports and oversees the development of study plans and documents (e.g., VOP, Data Review Plan, Safety Management Plan, Pharmacy Manual, IRT specifications, User Manuals)
• Coordinates the design, format, and content of study guides and subject instructions
• May participate in strategic governance discussions as required (e.g., SAB, BOD, DT, TAT, DSC, DOC)
• May support / be responsible for site and vendor invoice reviews
• Reviews and provides oversight of study trackers and metrics
• Provides oversight to development and review of study documents (i.e. Protocol, ICF, CRFs, IRT specifications, Inv product labels, etc)
• May be responsible for department strategic initiatives or process improvements
• May serve as a mentor and provide training to Sr. Clinical Trial Specialists (CTS)

SUPERVISORY RESPONSIBILITIES :

EDUCATION / EXPERIENCE / KNOWLEDGE & SKILLS :

Education / Experience :

Experience / The Ideal for Successful Entry into Job :

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JOB COMPLEXITY :

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EXHIBITS EXELIXIS LEADERSHIP COMMITMENTS :

LIVES THE EXELIXIS CORE VALUES DAILY :

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#LI-JD1

If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!

Our compensation reflects the cost of labor across severalU.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this positionis $135,500 - $192,500 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors.

In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.

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.