Clinical Development Scientist, Manager
Pfizer
9 days ago
Remote friendly (Cambridge, MA)
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 internal protocol review governance submissions and interactions
- Contribute to Study Informed Consent Documents and responses 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; present data; partner with site-facing colleagues to resolve data issues; ensure clinical queries are addressed for database lock
- Review safety data; contribute to clinical document updates; track and reconcile Serious Adverse Events; participate in Safety Review Team discussions; review safety narratives
- Support clinical 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; provide clinical input to site selection; deliver protocol training to sites
- Participate in investigator meetings; contribute to ongoing protocol training
- Develop and curate clinical protocol responses (e.g., FAQ)
- Contribute to protocol deviation management and reconciliation; support deviation trend review
- Ensure TMF compliance for clinical documents
- Provide clinical input/review of the Clinical Study Report
- Support disclosure of safety/efficacy data and trial conclusions; may contribute to primary publications
- Support audits and inspections; respond to findings
- Contribute to continuous improvement and process enhancement
Basic Qualifications:
- Science degree (PhD, PharmD, or equivalent); or MA/MS with 2+ years; or BA/BS with 4+ years Clinical Research experience in industry
- Phase 3/pivotal trial experience as sponsor-side support, including study design, start-up, conduct, and close-out, plus regulatory submissions and inspections
Preferred Qualifications:
- Cardiometabolic disease experience (e.g., obesity, diabetes, endocrinology)
- Scientific productivity (publications, posters, abstracts, presentations)
- Knowledge of clinical development, global/regional regulation, and ICH/GCP
- Strong clinical/administrative capabilities and verbal/written communication skills
- Ability to prioritize milestones to budgets and priorities
- Ability to resolve conflicts, negotiate, escalate appropriately, and take responsibility for decisions
- Demonstrate responsibility, team-focused success, and poise in uncertainty/organizational change
- 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 internal protocol review governance submissions and interactions
- Contribute to Study Informed Consent Documents and responses 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; present data; partner with site-facing colleagues to resolve data issues; ensure clinical queries are addressed for database lock
- Review safety data; contribute to clinical document updates; track and reconcile Serious Adverse Events; participate in Safety Review Team discussions; review safety narratives
- Support clinical 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; provide clinical input to site selection; deliver protocol training to sites
- Participate in investigator meetings; contribute to ongoing protocol training
- Develop and curate clinical protocol responses (e.g., FAQ)
- Contribute to protocol deviation management and reconciliation; support deviation trend review
- Ensure TMF compliance for clinical documents
- Provide clinical input/review of the Clinical Study Report
- Support disclosure of safety/efficacy data and trial conclusions; may contribute to primary publications
- Support audits and inspections; respond to findings
- Contribute to continuous improvement and process enhancement
Basic Qualifications:
- Science degree (PhD, PharmD, or equivalent); or MA/MS with 2+ years; or BA/BS with 4+ years Clinical Research experience in industry
- Phase 3/pivotal trial experience as sponsor-side support, including study design, start-up, conduct, and close-out, plus regulatory submissions and inspections
Preferred Qualifications:
- Cardiometabolic disease experience (e.g., obesity, diabetes, endocrinology)
- Scientific productivity (publications, posters, abstracts, presentations)
- Knowledge of clinical development, global/regional regulation, and ICH/GCP
- Strong clinical/administrative capabilities and verbal/written communication skills
- Ability to prioritize milestones to budgets and priorities
- Ability to resolve conflicts, negotiate, escalate appropriately, and take responsibility for decisions
- Demonstrate responsibility, team-focused success, and poise in uncertainty/organizational change