Clinical Development Scientist, Manager
Pfizer
9 days ago
Remote friendly (La Jolla, CA)
United States
Clinical Research and Development
Job Responsibilities:
- Provide clinical support for one or more studies; may support program-level clinical deliverables.
- Contribute to protocol development, including protocol amendments, Protocol Administrative Change Letters, and Dear Investigator Letters.
- Support study team in internal protocol review governance submissions and interactions.
- Contribute to Study Informed Consent Documents and respond to external stakeholder requests (e.g., Health Authority, Independent Ethics Committee).
- Provide clinical input to the Statistical Analysis Plan and Tables, Listings, and Figures.
- Perform clinical data review per the data review plan and best practices; may present data; partner with site colleagues to resolve data issues; ensure clinical queries are addressed to support database lock.
- Review safety data; track/reconcile Serious Adverse Events; participate in Safety Review Team meetings; review safety narratives; contribute to clinical document updates for emerging safety.
- Support activities consistent with the approved Risk Management Plan.
- Support External Data Monitoring Committees and Adjudication Committees (chartering, contracting, data provision/presentation, and dissemination of recommendations).
- Contribute to site selection criteria and provide clinical input; may deliver protocol training to sites.
- Contribute to clinical response development and curation (e.g., FAQ) for protocol questions.
- Support protocol deviation management and reconciliation; may contribute to deviation trend review.
- Ensure TMF compliance for clinical documents.
- Provide clinical input and review of the Clinical Study Report.
- Support disclosure of safety/efficacy data and trial conclusions; may contribute to primary publications.
- Support audits/inspections and address findings.
- Contribute to continuous improvement/process enhancement.
Qualifications:
- Science degree (PhD, PharmD, or equivalent), or MA/MS with at least 2 years, or BA/BS with at least 4 years of clinical research experience in a similar industry role.
- Clinical research experience preferably in Phase 3/pivotal trials on the sponsor side, including study design, start-up, conduct, close-out, regulatory submissions, and inspections.
Preferred Qualifications/Skills:
- Cardiometabolic disease experience (e.g., obesity, diabetes, endocrinology).
- Scientific productivity (publications, posters, abstracts, presentations).
- Knowledge of global/regional regulation and ICH/GCP.
- Strong verbal and written communication; clinical/administrative capability.
- Ability to set priorities and deliver milestones; equitable conflict resolution and negotiation.
- Team-oriented leadership; personal accountability for results; ability to work in uncertainty/change.
Work Conditions:
- Global travel may be required.
- Hybrid work location.
- Provide clinical support for one or more studies; may support program-level clinical deliverables.
- Contribute to protocol development, including protocol amendments, Protocol Administrative Change Letters, and Dear Investigator Letters.
- Support study team in internal protocol review governance submissions and interactions.
- Contribute to Study Informed Consent Documents and respond to external stakeholder requests (e.g., Health Authority, Independent Ethics Committee).
- Provide clinical input to the Statistical Analysis Plan and Tables, Listings, and Figures.
- Perform clinical data review per the data review plan and best practices; may present data; partner with site colleagues to resolve data issues; ensure clinical queries are addressed to support database lock.
- Review safety data; track/reconcile Serious Adverse Events; participate in Safety Review Team meetings; review safety narratives; contribute to clinical document updates for emerging safety.
- Support activities consistent with the approved Risk Management Plan.
- Support External Data Monitoring Committees and Adjudication Committees (chartering, contracting, data provision/presentation, and dissemination of recommendations).
- Contribute to site selection criteria and provide clinical input; may deliver protocol training to sites.
- Contribute to clinical response development and curation (e.g., FAQ) for protocol questions.
- Support protocol deviation management and reconciliation; may contribute to deviation trend review.
- Ensure TMF compliance for clinical documents.
- Provide clinical input and review of the Clinical Study Report.
- Support disclosure of safety/efficacy data and trial conclusions; may contribute to primary publications.
- Support audits/inspections and address findings.
- Contribute to continuous improvement/process enhancement.
Qualifications:
- Science degree (PhD, PharmD, or equivalent), or MA/MS with at least 2 years, or BA/BS with at least 4 years of clinical research experience in a similar industry role.
- Clinical research experience preferably in Phase 3/pivotal trials on the sponsor side, including study design, start-up, conduct, close-out, regulatory submissions, and inspections.
Preferred Qualifications/Skills:
- Cardiometabolic disease experience (e.g., obesity, diabetes, endocrinology).
- Scientific productivity (publications, posters, abstracts, presentations).
- Knowledge of global/regional regulation and ICH/GCP.
- Strong verbal and written communication; clinical/administrative capability.
- Ability to set priorities and deliver milestones; equitable conflict resolution and negotiation.
- Team-oriented leadership; personal accountability for results; ability to work in uncertainty/change.
Work Conditions:
- Global travel may be required.
- Hybrid work location.