Exel
Associate External Data Management Director
Alameda, CA · Director
Stay score
odds of building a lasting career here
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
$14,512 more — $174,512 — 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 $174,512 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 "Data Scientists" for prevailing-wage purposes.
DOL prevailing wage, 2026-27 wage year · Data Scientists (15-2051) · 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.
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from this employer's Department of Labor filings
Files H-1B transfers
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
- The Associate External Data Management Director is responsible for managing the processing of external and/or local lab data received by Exelixis throughout the clinical trial lifecycle.
- The base pay range for this position is $160,000 - $226,500 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.
Responsibilities
- Develop and maintain strong, collaborative relationships with internal study execution/management teams, CROs, laboratory service providers, and other key stakeholders.
- Develop the Data Transfer Plan (DTP), including the Data Quality Review reconciliation section for the external vendor data transfer(s), obtain final approvals and file document to the Trial Master File (TMF) as applicable.
- Develop and document external data edit checks and reports in the edit check template, obtain approvals and perform QC/UAT to verify the checks and reports are functioning properly.
- Collaborate with external functional setvice provider counterparts for study expectations including milestones, deliverable timelines, communication expectations, etc.
- Review external data discrepancies generated by edit checks and reports and perform subsequent query management to resolve data issues.
- Maintain appropriate documentation of data issues in both study and vendor logs and follow outcome to resolution.
- May assist with review of draft protocols from an external data perspective and assist with review of eCRF design per protocol parameters.
- Effectively plan and support multiple high quality external data management projects simultaneously and provide updates to line management or other relevant stakeholders as requested.
- They provide support to the Lead Data Manager (LDM), Clinical Operations as well as the Biosamples managment group with the review, maintenance, and management of external vendor.
- Leads functional service provider resources in a matrixed environment.
Requirements
- BS/BA degree in related discipline and a minimum of 11 years of related experience
- MS/MA degree in related discipline and a minimum of 9 years of related experience
- PhD in related discipline and a minimum of 5 years of related experience
- 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.
Nice to have
- Clinical or biological laboratory experience with a focus on processing and/or analyzing biological samples.
- Familiarity with oncology laboratory terminology and genomic biomarker and pharmacokinetic/pharmacodynamic endpoints derived from tissue and blood samples is essential.
- Preferred experience in oncology trial management.
- Strong understanding of FDA and ICH/GCP regulations and guidelines.
- Highly detail-oriented, with a creative mindset focused on process optimization.
- Excellent organizational and communication skills.
- A minimum of 7 years of clinical data management experience is also required in the pharmaceutical industry or clinical trials.
- A minimum of 4 years in a project leadership role.
Skills
- The ability to problem solve and have people/project leadership skills.
- Knowledge of GCP is essential.
- General knowledge of FDA regulations that govern the execution of clinical trials and Electronic Data Capture (EDC) systems required.
- Expertise in CDASH/CDISC standards preferred.
- Has extensive experience in relevant industry/profession and area of specialization.
- Uses professional concepts and company objectives to resolve complex issues in creative and effective ways.
- Has complete understanding and wide application of technical principles, theories, concepts, and techniques.
- Has good general knowledge of other related disciplines.
- Applies strong analytical and business communication skills.
- Demonstrated Project Management skills.
- Excellent verbal and written communication skills and interpersonal skills are required.
- Education/Experience:
Compensation
- The base pay range for this position is $160,000 - $226,500 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.
This listing is sourced directly from Exel's careers page and normalized into a canonical job model.