TheClinical 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.
JOB RESPONSIBILITIES
Provides clinical support for one or more studies; may provide support for program level clinical deliverables
Contributes to development of the protocol, including protocol amendments, Protocol Administrative Change Letters, and Dear Investigator Letters
Supports the study team in internal protocol review governance submissions and interactions
Contributes to Study Informed Consent Documents and responses to external stakeholder (e.g., Health Authority and Independent Ethics Committee) requests
May provide clinical input to the development of the Statistical Analysis Plan and Tables, Listings, and Figures
Performs clinical data review in accordance with the data review plan and clinical data review best practices; may present 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
Reviews safety data and may contribute to clinical document updates in response to emerging safety profile; tracks and reconciles Serious Adverse Events; participates in clinical safety data discussion during Safety Review Team meetings in collaboration with Medically Qualified Individual(s); reviews safety narratives
Contributes to clinical activities consistent with the approved Risk Management Plan
Supports establishment and management of External Data Monitoring Committees and Adjudication Committees, including chartering, contracting, provision and presentation of data, and documentation and dissemination of Committee recommendations
Contributes to site selection criteria, provides clinical input to selection of sites, and may deliver protocol training to site-facing colleagues
May participate in investigator meeting; may contribute to ongoing protocol training in response to e.g., protocol amendments, emerging data issues, and quality events
Contributes to clinical response development, delivery, documentation, and curation (e.g., in FAQ) for questions relating to clinical aspects of the protocol
May contribute to protocol deviation sub-category development; ensures protocol deviations identified during clinical data review are reported; contributes to protocol deviation management and reconciliation; may contribute to protocol deviation trends review
Ensures TMF compliance for clinical documents
Provides clinical input and review of the Clinical Study Report
Provides clinical support to disclosure of safety and efficacy data and trial conclusions; may contribute to primary publications
Provides clinical support to audits and inspections, including responding to and addressing audit and inspection findings
Contributes to continuous improvement / process enhancement activities and innovative approaches to maximize effectiveness of clinical trial execution
BASIC QUALIFICATIONS
Science degree (PhD, PharmD, or equivalent) with some, or MA/MS with at least 2 years, or BA/BS with at least 4 years of Clinical Research experience in a similar role in industry
Clinical research experience preferably in Phase 3/pivotal trial space, on the side of the sponsor, preferably with experience in study design, start-up, conduct, and close-out, including regulatory submissions and inspections
PREFERRED QUALIFICATIONS
Cardiometabolic disease experience, e.g., obesity, diabetes, endocrinology, etc.
Scientific productivity via publications, posters, abstracts and/or presentations
Knowledge of clinical development, global and regional regulation, and ICH/GCP
Clinical and administrative capabilities; effective verbal and written communication skills
Able to set priorities to deliver milestones according to budgets and priorities
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: Hybrid
The annual base salary for this position ranges from $106,000.00 to $176,600.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 15.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
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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