Pfizer
Clinical Development Scientist (Senior Director)
🇺🇸Collegeville, Pennsylvania, United States3 days ago
$215K – $358KSeniorFull Time
The Clinical Development Scientist (Senior Director) is responsible for scientific oversight, data integrity, and quality of clinical trials in Internal Medicine, with direct responsibility for clinical deliverables for one or more studies, leading and contributing to process improvement initiatives. They may also manage, supervise, and mentor others.
JOB RESPONSIBILITIES
Independently leads clinical execution of one or more studies; 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; may participate in protocol-related KOL and Health Authority interactions
Ensures development of Study Informed Consent Documents and responses to external stakeholder (e.g., Health Authority and Independent Ethics Committee) 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, ensuring alignment with the protocol and SAP, optimized data collection principles, and clinical data review best practice; sets the clinical data review strategy and leads the team in the review of emerging clinical data and trends; reviews and queries data; presents data to internal and external stakeholders; partners with site-facing colleagues in support of data issue resolution; ensures all clinical queries are appropriately addressed in support of database lock
Provides clinical guidance to the development of the Safety Review Plan and Safety Narrative Plan; reviews safety data and ensures clinical documents are updated in response to emerging safety profile; tracks and reconciles Serious Adverse Events; leads clinical safety data discussion during Safety Review Team meetings in collaboration with Medically Qualified Individual(s); reviews safety narratives
Provides clinical guidance to the development of the Risk Management Plan; ensures clinical activities are consistent with the approved Plan and partners with key stakeholders to develop and implement risk mitigations
Establishes and manages External Data Monitoring Committees and Adjudication Committees, including chartering, contracting, provision and presentation of data, and documentation and dissemination of Committee recommendations
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; develops and delivers ongoing protocol training in response to e.g., protocol amendments, emerging data issues, and quality events
Serves as the primary clinical point of contact with investigators and study team for questions relating to clinical aspects of the protocol; manages clinical response development, delivery, documentation, and curation (e.g., in FAQ)
Ensures protocol deviation sub-categories are established; ensures protocol deviations identified during clinical data review are reported; ensures all reported protocol deviations are appropriately managed and reconciled; leads protocol deviation trends review
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; may contribute to publications
Provides clinical support to audits and inspections, including responding to and addressing audit and inspection findings
May contribute to clinical sections of regulatory filings (e.g., Briefing Documents, Pediatric Investigational Plan, Investigator Brochure, IND/NDA Annual Reports, Periodic Safety Update Reports, responses to Health Authority requests)
Leads the adoption and implementation of continuous improvement / process enhancement activities and innovative approaches to maximize effectiveness of clinical trial execution at the program and portfolio levels; contributes to enterprise-level initiatives
May have managerial responsibility for other clinical colleagues or contingent workers; may supervise, mentor, or develop others
BASIC QUALIFICATIONS
Science degree (PhD, PharmD, or equivalent) with at least 7 years, or MA/MS with at least 10 years, or BA/BS with at least 12 years of Clinical Research experience in a similar role in the biopharmaceutical industry
PREFERRED QUALIFICATIONS
Cardiometabolic disease experience, e.g., obesity, diabetes, endocrinology, etc.
Clinical research experience in the biopharmaceutical industry in study design, start-up, conduct, and close-out, including regulatory submissions and inspections
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; able to coordinate and execute clinical development during design, start-up, conduct, close-out, and reporting
Understands the complexities and recent developments in the principal disease areas; competent discussing scientific and regulatory aspects of drug development
Able to set priorities and manage cross-functional teams and complex projects to deliver milestones according to budgets and priorities; able to define and manage resource requirements
Effective leader; able to mentor/coach, delegate to, and oversee others; able to develop others’ skills and move them toward autonomy
Able to resolve conflicts equitably; fosters open dialogue; addresses conflicts; reads situations quickly; negotiates agreements; escalates issues when appropriate; takes responsibility for decisions
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
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Global travel may be required
Work Location Assignment: This is a hybrid role requiring you to live within commuting distance and work on-site an average of 2.5 days per week.
Relocation assistance may be available based on business needs and/or eligibility.
Candidates must be authorized to be employed in the U.S. by any employer.
U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.
Sunshine Act
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EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.
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