Exelixis · 1 day ago
Senior Director, Clinical Operations Compliance Management (Biotechnology/Oncology)
Alameda, CA
Full-time
Onsite
Director/Executive
$246K/yr - $350K/yr
13+ years expExelixis is a biotechnology company focused on oncology, and they are seeking a Senior Director for Clinical Operations Compliance Management. This role is responsible for ensuring compliance in clinical research activities and managing risk and issue management processes within the clinical operations team.
BiotechnologyHealth CarePharmaceutical
Hiring Manager
Jodie Donaldson
Responsibilities
Leadership of risk and issue management process for Clinical Operations focusing on compliant delivery of study execution
Provide trends and other relevant reporting to Process Owners and Clinical Operations and/or appropriate Leadership Teams and help translate trends to enable process improvements and smart risk-based decisions
Define strategy and methodology for functional risk/issue management, create annual functional risk management plan to ensure inspection readiness, review periodically the outcomes of risk management/management monitoring; collaborate cross-functionally on risk management activities, and escalate to appropriate governance and adapt accordingly
Provide support to Clinical Operations (and other functions being supported by embedded compliance role) CAPA owners, including owner assignment, follow-up and completion
Provide development leadership with updates on CAPA completion data (late, near due, due later)
Work closely with and act as liaison for Quality Assurance team and other functional teams across R&D and beyond
Qualification
Required
Bachelor's degree in related discipline and a minimum of 15 years of related experience; or
Master's degree in related discipline and a minimum of 13 years of related experience; or
Doctoral degree in related discipline and a minimum of 12 years of related experience; or
Equivalent combination of education and experience
Typically requires a minimum of 15 years of related experience and/or combination of education/training and experience
Experience in biotech/pharmaceutical industry required
Experience in biotech/pharmaceutical industry: CROs, R&D outsourcing, purchasing or procurement roles required
Evidence of leadership and management skills of a team at a senior level in a relevant industry role involving strong engagement with external suppliers
Current understanding of the relevant external scientific, legal and regulatory environment
Prior experience leading a team
Leadership and networking skills
Communication and engagement skills
Partnership and collaboration skills
Influencing skills to drive robust oversight processes across a complex supplier landscape
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
Accountable for leading, designing and driving changes in ways of working across a complex network of stakeholders and SMEs
Ensure processes are efficient and minimize burden on business owners across the clinical landscape
Responsible for embedding a risk and issue management framework
May include occasional travel (less than 10%) to current and/or prospective vendor facilities
Benefits
401k plan with generous company contributions
Group medical, dental and vision coverage
Life and disability insurance
Flexible spending accounts
Discretionary annual bonus program
Sales-based incentive plan
Opportunity to purchase company stock
Receive long-term incentives
15 accrued vacation days in their first year
17 paid holidays including a company-wide winter shutdown in December
Up to 10 sick days throughout the calendar year
Company
Exelixis
Exelixis works is focused on discovering, developing and commercializing therapies for the treatment of cancer and other serious diseases.
1001-5000 employees
H1B Sponsorship
Exelixis has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (39)
2024 (25)
2023 (25)
2022 (28)
2021 (29)
2020 (15)
Funding
Current Stage
Public CompanyTotal Funding
$514MKey Investors
Deerfield
2015-07-23Post Ipo Equity· $135M
2012-02-16Post Ipo Equity· $65M
2010-06-03Post Ipo Debt· $160M
Leadership Team
Michael Morrissey
President and CEO
Christopher Senner
Executive Vice President and CFO
Recent News
2026-01-07
Investor's Business Daily
2025-12-22
Company data provided by crunchbase