Clinical Development Scientist, Manager
Pfizer
5 hours ago
Remote friendly (New York, NY)
United States
Clinical Research and Development
Clinical Development Scientist (Manager) provides support for scientific oversight, data integrity, and quality of clinical trials in Internal Medicine, with direct responsibility for clinical deliverables for one or more studies.
Responsibilities:
- Provide clinical support for one or more studies; contribute to program-level clinical deliverables.
- Contribute to protocol development and amendments; support governance submissions and interactions.
- Contribute to informed consent documents and responses to Health Authority/Independent Ethics Committee requests.
- Provide clinical input to the Statistical Analysis Plan and TLFs.
- Perform clinical data review per the data review plan; support data issue resolution with sites; ensure clinical queries are addressed for database lock.
- Review safety data; track/reconcile SAEs; contribute to safety review discussions, safety narratives, and safety-related document updates.
- Support activities aligned with the Risk Management Plan.
- Support External Data Monitoring Committees and Adjudication Committees (chartering, contracting, data provision/presentation, documentation/dissemination of recommendations).
- Contribute to site selection criteria and provide protocol training; support investigator meetings and protocol training.
- Contribute to clinical response development and curation (e.g., FAQ); support protocol deviation management and reconciliation.
- Ensure TMF compliance; provide clinical input/review of the Clinical Study Report.
- Support safety/efficacy disclosure, trial conclusions, publications; support audits/inspections and findings resolution.
- Contribute to continuous improvement to enhance clinical trial execution.
Basic Qualifications:
- 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 on sponsor side; experience in design, start-up, conduct, close-out, including regulatory submissions and inspections.
Preferred Qualifications:
- Cardiometabolic disease experience (e.g., obesity, diabetes, endocrinology).
- Publications/posters/abstracts/presentations; knowledge of clinical development, global/regional regulation, ICH/GCP.
- Strong communication; ability to prioritize, resolve conflicts, and take ownership.
Benefits/Work Requirements:
- Hybrid work location; global travel may be required.
- Salary range: $106,000–$176,600; bonus target 15% and eligibility for long-term incentives; comprehensive benefits (e.g., 401(k) with match, paid leave, medical/dental/vision).
Responsibilities:
- Provide clinical support for one or more studies; contribute to program-level clinical deliverables.
- Contribute to protocol development and amendments; support governance submissions and interactions.
- Contribute to informed consent documents and responses to Health Authority/Independent Ethics Committee requests.
- Provide clinical input to the Statistical Analysis Plan and TLFs.
- Perform clinical data review per the data review plan; support data issue resolution with sites; ensure clinical queries are addressed for database lock.
- Review safety data; track/reconcile SAEs; contribute to safety review discussions, safety narratives, and safety-related document updates.
- Support activities aligned with the Risk Management Plan.
- Support External Data Monitoring Committees and Adjudication Committees (chartering, contracting, data provision/presentation, documentation/dissemination of recommendations).
- Contribute to site selection criteria and provide protocol training; support investigator meetings and protocol training.
- Contribute to clinical response development and curation (e.g., FAQ); support protocol deviation management and reconciliation.
- Ensure TMF compliance; provide clinical input/review of the Clinical Study Report.
- Support safety/efficacy disclosure, trial conclusions, publications; support audits/inspections and findings resolution.
- Contribute to continuous improvement to enhance clinical trial execution.
Basic Qualifications:
- 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 on sponsor side; experience in design, start-up, conduct, close-out, including regulatory submissions and inspections.
Preferred Qualifications:
- Cardiometabolic disease experience (e.g., obesity, diabetes, endocrinology).
- Publications/posters/abstracts/presentations; knowledge of clinical development, global/regional regulation, ICH/GCP.
- Strong communication; ability to prioritize, resolve conflicts, and take ownership.
Benefits/Work Requirements:
- Hybrid work location; global travel may be required.
- Salary range: $106,000–$176,600; bonus target 15% and eligibility for long-term incentives; comprehensive benefits (e.g., 401(k) with match, paid leave, medical/dental/vision).