Exelixis

SUMMARY/JOB PURPOSE:

Ensures risk management, issue management, and risk/issue monitoring are implemented and embedded across their responsible trial portfolio and functional areas of focus. Ensures clinical research activities are conducted by clinical staff in accordance with ICH GCP, relevant international and local regulations, requirements, and guidelines. Partners with quality assurance (QA) teams and other functional groups across PDMA to execute inspection readiness, risk management, oversight of quality performance metrics, and issue escalation of quality issues. The Director provides Good Clinical Practice (GCP) guidance and best-practice expertise to facilitate optimal clinical trial execution compliance management as it relates to Process Deviations and CAPA management to and ensure study adherence to applicable GCP regulations throughout all phases of clinical development.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• As part of Clinical Compliance and Risk Management (CCRM) Team, represent Development Operations and collaborate with Quality Assurance on compliance-related activities, processes and functions
• Support Development Operations functions and Clinical Study Delivery Teams to maintain readiness, prepare for, and participate in regulatory agency inspections and Quality audits
• Display active leadership as it relates to Development Operations management of process deviations, audit and inspection findings, and CAPAs
• Manage and track Development Operations internal and external audit responses. Support input and the review of investigator, vendor, process and system audits to ensure responses are complete and provided in a timely manner
• Manage and track Development Operations and Vendor assigned CAPAs validation, processing and resolution to ensure on time closure. Translate and facilitate with functional area partners an outcome to defined process, study plans or training updates
• Ensure inspection readiness, review periodically the outcomes of risk management/ management monitoring; escalate to appropriate governance and adapt accordingly
• Collaborate with cross functional teams to identify compliance program risks and mitigation strategies
• Establish and maintain CCRM key performance indicators, and metrics tools that interfaces with Quality Assurance representing the state of compliance for Development Operations
• Create and lead CCRM initiatives and infrastructure that drive compliance
• Collaborate with CCRM team members to ensure achievement of corporate and department goals

SUPERVISORY RESPONSIBILITIES:

• None

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education/Experience:

• BS/BA degree in related discipline and a minimum of 13 years of related experience; or,
• MS/MA degree in related discipline and a minimum of 11 years of related experience; or,
• PhD in related discipline and a minimum of 8 years of related experience; or,
• Equivalent combination of education and experience.
• May require certification in assigned area.

Experience/The Ideal for Successful Entry into Job:

• Typically requires a minimum of 16 years of related experience or the equivalent combination of experience and education/training.
• Typically requires a minimum of 12 years of pharmaceutical/biotechnology/CRO in quality management of clinical trials, training, clinical operations, project management.
• Advanced knowledge of ICH-GCP guidelines and applicable drug development regulations.
• Experienced in leading inspection readiness activities
• Experienced in leading the development of SOPs and other process related documentation.
• Experienced in supporting clinical trial GCP compliance/quality management activities.
• Strong understanding of drug development and clinical trial execution, including other required functional areas involved in clinical trials.
• Strong working knowledge of Clinical Risk Management and Mitigation strategies.

Knowledge/Skills:

• In-depth knowledge of biopharmaceutical industry regulations, standards and best practices.
• Poise and confidence to provide verbal and written communications and formal presentations to Exelixis; and external vendors; executives, senior management, functional management and individual contributors.
• Must be a self-starter, quick learner, strong collaborator and team player with ability to work independently with minimal supervision.
• Must have excellent analytical, strategic thinking, problem-solving, time management, change management and organizational skills with demonstrated ability to work in a fast-paced environment and adapt to changing business plans and priorities.
• Strong interpersonal, verbal and written communication skills.
• Strong attention to detail.
• Ability to identify and communicate issues and risks.
• Excellent presentation skills.
• Ability to build and maintain strong relationships.
• Ability to influence without direct authority.
• Excellent computer skills, including advanced knowledge of Microsoft Excel, Word, PowerPoint and Outlook.
• Embraces Exelixis core values: Be Exceptional; Excel for Patients; Exceed Together.

JOB COMPLEXITY:

• Applies judgement and professional expertise in new situations.
• Independent team member performing highly technical or specialized work.
• Responsible for executing a risk and issue management framework.
• Responsible for executing inspection readiness for clinical trial teams.

WORKING CONDITIONS:

• May include occasional business travel (less than 10%)
• 5 Day onsite office presence

#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 several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $174,000 - $248,500 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.