Exel
Senior Director, Clinical Operations (Biotech, Oncology)
Alameda, CA · Director
Sponsorship not specified$246k-$350kDetected 28 days ago
StatisticsProject ManagementStakeholder ManagementNegotiationProcurementClinical TrialsPharmacologyFDA RegulatoryResearchLeadershipCommunicationCollaborationMentoringBiostatisticsRegulatory Affairs
Stay score
odds of building a lasting career here
61Sponsors, lottery-bound
Cap-exempt (no lottery)0
Sponsors this role90
Entry-level history0
PERM / green-card track0
Lottery odds (Level IV)94
Fits your clock70
Sponsors, but it's cap-subject — you still face the weighted lottery (~61% per draw at Level IV). Good if you win; have a cap-exempt backup on your list.
Lottery odds assume a STEM candidate.
Personalize to your clock →H-1B wage level
the lottery is wage-weighted — each level is one more entry
Level I$167,6481 entry
Level II$208,5822 entries
Level III$249,5383 entries
Level IV$290,4724 entries
$3,538 more — $249,538 — moves this role to Level III and 3 lottery entries. That figure is inside the range the employer already advertised.
Based on the DOL prevailing wage for this occupation and worksite, a base salary of $249,538 would place this position at wage Level III. That figure is within the posted range, and I'd like to target it. This role classifies under "Natural Sciences Managers" for prevailing-wage purposes.
DOL prevailing wage, 2026-27 wage year · Natural Sciences Managers (11-9121) · San Francisco-Oakland-Fremont, CA. Wage level is derived by USCIS from the offered wage, occupation and worksite; the occupation shown is inferred from the job title.
Employer immigration record
from this employer's Department of Labor filings
Files H-1B transfers
1 transfer filing in the last year, covering 1 worker. Median labor-condition decision: 9 days. An employer that already files transfers is one that can take over an existing H-1B.
Sourced from Department of Labor LCA, PERM and prevailing-wage disclosure data. Employer matching is by name, so figures may be split across an employer's legal entities. Absence of a filing means none appears in our copy of the data, not that none exists.
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About the role
- SUMMARY/JOB PURPOSE The Senior Director, Clinical Operations (ClinOps) is responsible for the worldwide execution of all oncology Phase I - IV clinical trials across the Exelixis portfolio.
- This position is accountable for resource management across assigned program, including ongoing assessment of resource needs and optimal deployment of resources.
- Works seamlessly with CRO and vendors, attending governance and oversight meetings, to ensure optimal delivery to plan.
Responsibilities
- Accountable for delivery of a program of studies in Oncology diseases; and be a key point of contact for portfolio leaders (e.g., Product Team Lead and/or Project Physician Leaders, as appropriate).
- Lead resourcing discussions on behalf of Clinical Operations, making recommendations on strategy; endorses the vendor(s) for the program and studies in accordance with the Clinical Operations resourcing strategy & principles; and ultimately approve the Clinical Operations FTE plan to support the program.
- Oversight of quality delivery by leading the Clinical Operations team to ensure excellence in operational planning and implementation; and being the escalation point for the program in Clinical Operations; ensuring inspection readiness at all times and having regular interactions with Study Delivery Leads involved in the program such that they are aware of issues / risks / successes with study delivery as they occur.
- Responsible for various scenarios for optimal program/study delivery linked to value drivers and drives decisions for governance boards to optimize delivery with transparent implications to time, quality, risks, and budget.
- Participate in and represent Clinical Operations at Product Development Team (PDT); co-lead Clinical Sub-team; and other internal governance boards as needed.
- Drive innovative approaches to study delivery through external facing advances in technology and science.
- Manage Study Delivery Leads and / or Indication Leads and a mentor to other Clinical Operations team members, with a particular emphasis on coaching and development.
Requirements
- Bachelor's degree in related discipline and a minimum of 15 years of related experience
- Master's degree in related discipline and a minimum of 13 years of related experience
- PhD degree in related discipline and a minimum of 12 years of related experience
- Ability to translate strategic concepts, scientific requirements, stakeholder feedback and requirements into cohesive actions for the Product team.
Skills
- 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,
- PhD 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 18 years of related experience or the equivalent combination of experience and education/training.
- Experience in Biotech/Pharmaceutical industry preferred.
- Management experience including outsourcing to Contract Research Organizations (CROs).
- Ability to define value-driven vision and roadmap for the Clinical Development Plan
Compensation
- Represent Clinical Operations in the development and finalization of annual Product corporate and project goals; continuously track and communicate status of goals throughout the year.
Benefits
- Contribute relevant knowledge of scientific and medical literature in the Oncology field to apply to operational goals.
Company info
- The Senior Director, Clinical Operations (ClinOps) is responsible for the worldwide execution of all oncology Phase I - IV clinical trials across the Exelixis portfolio.
- ClinOps plays a key role in ensuring all Exelixis clinical trials are performed in accordance with applicable SOPs, company policies, and regulatory guidelines to provide timely and high-quality clinical data that supports global registration and commercialization of Exelixis' oncology products.
- The Senior Director, Clinical Operations represents ClinOps at the Product Development Team (PDT) as the Clinical Operations Program Lead.
- The Clinical Operations Program Lead is accountable for developing the operational strategy and delivery plan to execute the scientific strategy for a product(s) and associated studies, working in partnership with clinical / biostats / clinical supplies and the functional subject matter experts to ensure informed asset decision-making from the operational, scientific and data perspectives.
- This position provides line leadership to Study Delivery Leads and / or Indication Leads from Senior Clinical Trial Manager to Director level to ensure optimal delivery of program clinical studies through the successful execution of the goals and deliverables outlined in the program corporate and project goals.
- As a Senior Director, oversees large clinical programs and represents Clinical Operations on internal and external strategy teams, including Product Development Teams (PDTs) which entails accountability for the operational strategy and successful execution of all Clinical Development Plans related to your assigned programs, including financial accountability.
- Serves as an expert resource by offering input / ideas to solve operational challenges for all clinical studies in the assigned program and providing expertise to PDT, clinical sub team, etc.
- In addition, this role is an active member of the Clinical Operations leadership team, leading Clinical Operations and/or cross-functional organizational initiatives and strategies that promote change management to accelerate adoption.
- Typically acts as the business process owner (BPO) and/or serves as a subject matter expert for complex Clinical Operations processes.
- Demonstrates an innovative mindset by championing new ideas and initiatives and incorporating best practices, external benchmarking, and standardization across Clinical Operations.
This listing is sourced directly from Exel's careers page and normalized into a canonical job model.