Exelixis · 3 weeks ago
Clinical Operations Associate Director (Oncology / Biotechnology)
Alameda, CA
Full-time
Onsite
Lead/Staff, Director/Executive
$190K/yr - $270K/yr
9+ years expExelixis is a biotechnology company focused on oncology, seeking a Clinical Operations Associate Director to lead the design, execution, and reporting of clinical trials. This role is accountable for the delivery of studies, ensuring compliance with protocols and collaboration with various teams to meet project objectives.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Accountable for the global study delivery strategy (e.g., country selection, diversity, patient engagement strategy, recruitment plan, etc.) and for overall study deliverables
Guide assessment, selection, engagement, management, and oversight of appropriate vendors
Assure consent with ICH/GCP guidelines, all applicable laws and regulations, and Exelixis SOPs, for all products and services delivered for their designated studies
Responsible for making decisions that balance risk/benefit with clear understanding of impact on the study and project; takes action to mitigate risk where appropriate
Collaborate with matrix partners, Clinical Operations Program Lead and/or manager to develop and manage study level budget within project allocation
Responsible for the preparation of materials for internal governance and / or financial review cycles
Actively partner to build relationships and collaborate with aligned staff in other functions
Encourage others within matrix and line teams to seek alternative perspectives and develop solutions
Lead and conduct investigator meetings and other study related meetings and participate in governance meetings as necessary
Identify and communicate resource gaps for assigned studies
Lead risk management and quality efforts to ensure study compliance and continual inspection readiness
Lead/contribute to ways of working and process improvement initiatives
Provide expert clinical operational input into protocol development
Partner with Data Management and Clinical Sciences to develop the data cleaning strategy for the study
As the SDL, lead the SDT and actively partner to build relationships and collaborate with SDT
Work with the appropriate functions to develop patient centric documents and address patient burden
Contribute to and engage Clinical Operations staff in process development, innovative problem solving, training initiatives as needed
Provide proactive and consistent oversight of CRO and vendor performance
Support Clinical Operations Program and / or Indication Lead with key study level status updates, with a particular focus on delivery to corporate and project level objectives
Qualification
Required
BS/BA and a minimum of 11 years of related experience; or
MS/MA degree in related discipline and a minimum of 9 years of related experience; or
PhD/PharmD in biological sciences or related field and a minimum of 5 years of related experience; or
Equivalent combination of education and experience
Extensive clinical development experience with at least 6 years as a global study leader with proven experience in driving operational study delivery to time, cost, and quality within the pharmaceutical / biotech industry or CRO environment
Proven operational experience of leading high performing global study teams in Oncology clinical trials
Proactively identify and resolve issues to ensure timely study delivery to quality, timelines, and budget
Excellent leadership skills, influencing and negotiation skills
Demonstrated experience leading in the matrix environment to deliver projects, develop clinical plans and manage change
In-depth knowledge of either study management or data management and knowledge of essential global regulatory guidelines and ICH/GCP
Proven experience working with investigators, external experts and regulatory agencies and oversight of Contract Research Organizations and third-party vendors including realigning with CRO partners when deliverables are at risk, negotiating solutions and leading After Action Reviews to share lessons learned
Ability to establish and build internal and external relationships at all levels in a highly dynamic and matrixed environment
Excellent project management skills and budget management skills
Possess competent written skills and experienced in authoring patient facing materials, study procedures manuals, pharmacy manuals, and informed consent forms
Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles and to achieve goals in creative and effective ways
Interprets, executes and recommends modifications to companywide policies and/or divisional programs. May establish organizational policies in a major segment of the company
Has extensive knowledge of other related disciplines
Applies strong analytical and business communication skills
Preferred
Experience in Biotech/Pharmaceutical industry preferred
Management experience including outsourcing to Contract Research Organizations (CROs)
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
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
2026-01-12
The Motley Fool
2026-01-09
Company data provided by crunchbase