Clinical Development Scientist (Senior Director)
Pfizer
17 days ago
Remote friendly (La Jolla, CA)
United States
Clinical Research and Development
Job Responsibilities:
- Independently leads clinical execution of one or more studies; accountable for program level clinical deliverables.
- Leads development of protocols, including protocol amendments, Protocol Administrative Change Letters, and Dear Investigator Letters.
- Represents study team in internal protocol review governance; partners with Global Development Lead on study/disease area strategy; may support KOL and Health Authority interactions.
- Ensures Study Informed Consent Documents and responses to Health Authority/Independent Ethics Committee requests.
- Provides clinical guidance for Statistical Analysis Plan and Tables, Listings, and Figures.
- Sets clinical data review strategy; leads review of emerging clinical data/trends; reviews/queries data; supports resolution and addresses queries for database lock.
- Provides guidance for Safety Review Plan/Narrative Plan; reviews safety data and updates clinical documents; tracks/reconciles SAEs; leads safety discussions in Safety Review meetings; reviews safety narratives.
- Ensures clinical activities align with Risk Management Plan; partners on risk mitigations.
- Establishes/manages External Data Monitoring Committees and Adjudication Committees.
- Develops site selection criteria; provides clinical input; ensures protocol training to sites.
- Plans investigator meetings; develops/delivers protocol training and ongoing updates.
- Primary clinical point of contact for protocol questions; manages clinical response development/FAQ curation.
- Ensures protocol deviation sub-categories; reports and manages deviations; reviews deviation trends.
- Ensures TMF compliance; provides clinical input/review of Clinical Study Report.
- Ensures disclosure of safety/efficacy data and trial conclusions; may contribute to publications.
- Supports audits/inspections; may contribute to regulatory filings.
- Leads continuous improvement/process enhancement; may supervise/mentor others.
Basic Qualifications:
- Science degree (PhD, PharmD, or equivalent) with 7+ years; or MA/MS with 10+ years; or BA/BS with 12+ years Clinical Research experience in biopharmaceutical industry.
Preferred Qualifications:
- Cardiometabolic disease experience (e.g., obesity, diabetes, endocrinology).
- Biopharma clinical research experience across design/start-up/conduct/close-out; regulatory submissions and inspections.
- Scientific productivity (publications/posters/abstracts/presentations).
- Knowledge of clinical development, global/regional regulation, and ICH/GCP.
- Clinical/administrative/project management and communication skills.
- Experience launching/managing/training clinical development teams.
Benefits/Compensation:
- Annual base salary range: $214,900.00–$358,100.00; eligible for Global Performance Plan bonus target 22.5% of base salary; and other long-term incentives. Benefits include 401(k) with matching, paid time off, caregiver/parental and medical leave, and medical/dental/vision coverage.
Application Instructions:
- None provided.
- Independently leads clinical execution of one or more studies; accountable for program level clinical deliverables.
- Leads development of protocols, including protocol amendments, Protocol Administrative Change Letters, and Dear Investigator Letters.
- Represents study team in internal protocol review governance; partners with Global Development Lead on study/disease area strategy; may support KOL and Health Authority interactions.
- Ensures Study Informed Consent Documents and responses to Health Authority/Independent Ethics Committee requests.
- Provides clinical guidance for Statistical Analysis Plan and Tables, Listings, and Figures.
- Sets clinical data review strategy; leads review of emerging clinical data/trends; reviews/queries data; supports resolution and addresses queries for database lock.
- Provides guidance for Safety Review Plan/Narrative Plan; reviews safety data and updates clinical documents; tracks/reconciles SAEs; leads safety discussions in Safety Review meetings; reviews safety narratives.
- Ensures clinical activities align with Risk Management Plan; partners on risk mitigations.
- Establishes/manages External Data Monitoring Committees and Adjudication Committees.
- Develops site selection criteria; provides clinical input; ensures protocol training to sites.
- Plans investigator meetings; develops/delivers protocol training and ongoing updates.
- Primary clinical point of contact for protocol questions; manages clinical response development/FAQ curation.
- Ensures protocol deviation sub-categories; reports and manages deviations; reviews deviation trends.
- Ensures TMF compliance; provides clinical input/review of Clinical Study Report.
- Ensures disclosure of safety/efficacy data and trial conclusions; may contribute to publications.
- Supports audits/inspections; may contribute to regulatory filings.
- Leads continuous improvement/process enhancement; may supervise/mentor others.
Basic Qualifications:
- Science degree (PhD, PharmD, or equivalent) with 7+ years; or MA/MS with 10+ years; or BA/BS with 12+ years Clinical Research experience in biopharmaceutical industry.
Preferred Qualifications:
- Cardiometabolic disease experience (e.g., obesity, diabetes, endocrinology).
- Biopharma clinical research experience across design/start-up/conduct/close-out; regulatory submissions and inspections.
- Scientific productivity (publications/posters/abstracts/presentations).
- Knowledge of clinical development, global/regional regulation, and ICH/GCP.
- Clinical/administrative/project management and communication skills.
- Experience launching/managing/training clinical development teams.
Benefits/Compensation:
- Annual base salary range: $214,900.00–$358,100.00; eligible for Global Performance Plan bonus target 22.5% of base salary; and other long-term incentives. Benefits include 401(k) with matching, paid time off, caregiver/parental and medical leave, and medical/dental/vision coverage.
Application Instructions:
- None provided.