# Clinical Development Scientist (Director)

**Company**: Pfizer
**Location**: Pennsylvania - Collegeville
**Work arrangement**: hybrid
**Experience**: senior
**Job type**: full-time
**Salary**: $176,600.00 to $294,300.00
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://pfizer.wd1.myworkdayjobs.com/en-US/PfizerCareers/job/United-States---Pennsylvania---Collegeville/Director--Clinical-Development-Scientist--Non-MD-_4967555-1?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/job/clinical-development-scientist-director-d548efb9-8f4/

## Description

The Clinical Development Scientist (Director) is responsible for scientific oversight, data integrity, and quality of clinical trials in Internal Medicine.

**Job Responsibilities**

- Independently leads clinical execution of one or more studies; may be accountable for program level clinical deliverables

- May provide input to the protocol design document; leads development of the protocol, including protocol amendments, Protocol Administrative Change Letters, and Dear Investigator Letters

- Represents the study team in internal protocol review governance submissions and interactions; partners with/supports the Global Development Lead in study and disease area strategy

- Ensures development of Study Informed Consent Documents and responses to external stakeholder requests

- Provides clinical guidance to the development of the Statistical Analysis Plan and Tables, Listings, and Figures

- Provides clinical guidance to the development of the clinical data collection strategy, instruments, and data review plan

- Provides clinical guidance to the development of the Safety Review Plan and Safety Narrative Plan

- Establishes and manages External Data Monitoring Committees and Adjudication Committees

- Develops site selection criteria, provides clinical input to selection of sites, and ensures protocol training is delivered to site-facing colleagues

- Participates in investigator meeting planning and develops and delivers protocol training

- Serves as the primary clinical point of contact with investigators and study team for questions relating to clinical aspects of the protocol

- Ensures protocol deviation sub-categories are established; ensures protocol deviations identified during clinical data review are reported

- Ensures TMF compliance for clinical documents

- Provides clinical input and review of the Clinical Study Report

- Ensures disclosure of safety and efficacy data and trial conclusions

- Provides clinical support to audits and inspections

- May contribute to clinical sections of regulatory filings

- Contributes to continuous improvement / process enhancement activities and innovative approaches to maximize effectiveness of clinical trial execution

- May have managerial responsibility for other clinical colleagues or contingent workers

**Basic Qualifications**

- Science degree (PhD, PharmD, or equivalent) with at least 5 years, or MA/MS with at least 7 years, or BA/BS with at least 8 years of Clinical Research experience in a similar role in the biopharmaceutical industry

**Preferred Qualifications**

- Cardiometabolic disease experience

- Clinical research experience in the biopharmaceutical industry in study design, start-up, conduct, and close-out

- Scientific productivity via publications, posters, abstracts and/or presentations

- Extensive knowledge of clinical development, global and regional regulation, and ICH/GCP

- Clinical, administrative, and project management capabilities; effective verbal and written communication skills

- Experience launching, managing, and training clinical development teams

- Track record of achievement in pharmaceutical development

- Understands the complexities and recent developments in the principal disease areas

- Able to set priorities and manage cross-functional teams and complex projects to deliver milestones according to budgets and priorities

- Effective leader; able to mentor/coach, delegate to, and oversee others

- Able to resolve conflicts equitably; fosters open dialogue; addresses conflicts

- Shares wins and success; defines success in terms of the whole team; develops strong team morale and spirit; creates a sense of belonging

- Takes personal responsibility for delivery of results

- Able to demonstrate perspective and poise in uncertainty and organizational change

- Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot

- Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices

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## Skills

### Required
- Clinical Research
- Protocol Development
- Statistical Analysis
- Clinical Guidance
- Safety Review
- Risk Management

### Nice to have
- Cardiometabolic disease experience
- Clinical research experience
- Scientific productivity
- ICH/GCP
- Leadership
- Project Management

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Source: [Apply at pfizer.wd1.myworkdayjobs.com](https://pfizer.wd1.myworkdayjobs.com/en-US/PfizerCareers/job/United-States---Pennsylvania---Collegeville/Director--Clinical-Development-Scientist--Non-MD-_4967555-1?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)