Exelixis · 1 day ago
Clinical Trials Manager (Biotechnology Oncology)
Alameda, CA
Full-time
Onsite
Senior Level
$136K/yr - $192K/yr
5+ years expExelixis is a biotechnology company focused on oncology drug discovery and development. The Clinical Trials Manager coordinates the activities associated with the evaluation, initiation, and management of solid tumor oncology clinical trials, overseeing execution and collaborating with cross-functional teams.
BiotechnologyHealth CarePharmaceutical
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)
Qualification
Required
BA/BA/BSN in biological sciences or related field and a minimum of 7 years of related experience; or
MS/MA/MSN in biological sciences or related field and a minimum of 5 years of related experience; or
PhD/PharmD in biological sciences or related field and zero or more years of related experience; or
Equivalent combination of education and experience
Typically requires a minimum of 7 years of related experience in life sciences, including 5 years in experience in clinical research
Experience in either starting a study up, maintenance phase, or study close-out
Experience with development of prospective site-selection criteria
Protocol development experience
Maintain a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, local regulatory requirements, SOPs, and study-specific procedures
Familiar with advanced concepts of clinical research
Ability to deal with time demands, incomplete information or unexpected events
Experience in interactions with outside vendors, e.g., CROs and contract labs
Experience with reviewing adequacy of site-proposed ICs for compliance with relevant regulations
Demonstrated ability to write and present clearly using on scientific and clinical issues terminology
Strong organizational and planning skills
Strong interpersonal skills and communication skills (both written and oral)
Ability to work effectively in a team/matrix environment
Ability to understand technical, scientific, and medical information
Demonstrated success in problem-solving
Ability to anticipate and resolve problems
Ability to write and present clearly, especially on scientific and clinical issues
Demonstrated professional collaboration skills
Understands departmental processes and implements solutions to address any task-related challenges
Identifies and escalates issues that may have a broader impact
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
The Motley Fool
2026-01-09
2026-01-08
Company data provided by crunchbase