The clinical scientist lead is a clinician who will provide medical and scientific program support for a global clinical scientist team on a program, ensuring consistency of approach and strategy and appropriate oversight of clinical scientist activities within a program or provide medical and scientific support for multiple, global, Phase 1-4 clinical studies.
The clinical scientist lead is responsible for clinical scientist project management support on a program level and/or responsible for studies with a high degree of complexity, in emerging regions of the world, or large studies. They are responsible for working collaboratively with the clinical lead physician and lead study clinician physicians and may develop clinical development plans and study strategies in support of the plans.
The clinical scientist support includes multiple tasks within the categories of 1) program, protocol, and study design and training, 2) data review and interpretation, 3) study and/or program scientific and integrity oversight, 4) safety review and communication, 5) regulatory document, study report and publication preparation and review, and 6) clinical study implementation oversight, with a critical focus on consistency, quality, data integrity, safety, and alignment with company values.ROLE RESPONSIBILITIES
Performs clinical scientist activities or oversees all clinical scientist activities for a clinical program including:
- Protocol and study design and training.
- Data review and interpretation.
- Study and/or program scientific and integrity oversight.
- Safety review and communication in collaboration with safety risk leads.
- Regulatory document, study report, and publication review and preparation.
- Clinical study implementation oversight.
- Ensures consistency, quality, data integrity, safety, and alignment with company values in all clinical scientist activities.
Represents clinical scientist program-wide functions on Clinical Project Team, Clinical Scientist Leadership, Clinical Program Team, Clinical Study Teams, Asset Operational meetings, Asset Program Teams, and Regulatory Strategy teams. May manage and lead Clinical Project Team meetings. Ensures individual contributor clinical scientists are aligned and consistent in their approach to process and strategy interpretation across all studies within a program. Contributes to discussions to ensure consistency across all programs.
May provide line management support for other clinical scientists within the program. Reviews work, develops staff, ensures appropriate succession planning, and provides ongoing feedback. Responsible for short- and long-term resource planning, priority setting, and filling of resource and skill gaps to address the needs of the program(s).
Using expert knowledge of vaccine clinical trials, provides oversight of operational strategic partner involvement at a program or study level and in collaboration with lead study clinicians and clinical lead. Identifies issues in a timely manner, leads implementation of complex solutions, and/or escalates as appropriate working with clinical lead, lead clinician, Development Operations program lead and Alliance Partner representatives.
Provides clinical scientist leadership role in preparation of regulatory submissions, responses to regulatory queries, and in preparation for program regulatory inspections and audits. In collaboration with the clinical lead, prepare strategy decisions, present and discuss data at relevant team, governance, external consultants, Key Opinion Leaders and potentially regulatory meetings.
Represents Vaccine Clinical Research (VCR) and may take the lead on company-wide, global process improvement initiatives, and champions process enhancements and solutions for complex issues. Leads change for VCR on new company initiatives.
Influences management/senior staff decisions and is viewed as the subject matter expert on clinical scientist decisions impacting a program and potentially the clinical research unit.
Collaborates with clinical program lead and other team members on development of program strategy and Clinical Development Plan for a program or multiple programs.QUALIFICATIONS
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact. Must Have
Nice To Have
- BA/BS science or health-related field
- Minimum 8 years' experience in Clinical Research including a working understanding of clinical protocol development and other required documents (e.g. Informed Consent)
- Expert working knowledge of Clinical Data Review including query generation and management
- Expert working knowledge of the clinical research process and Good Clinical Practices
- Strong written and oral communication and cross-functional collaborative skills
- Strong ability to work independently
- Proficiency with Word, PowerPoint, and Excel
OTHER JOB DETAILS
- MS or PhD in science or health-related field
- Experience with managing colleagues, either direct reports or matrix management
- Working knowledge of vaccine therapeutic area
- Demonstrated ability and level of experience with integrating and summarizing medical/scientific concepts in protocols and other clinical documents
- Independently authored clinical protocols and other clinical study documents
- Experience with participating in and informally leading an operational team
- Applies knowledge of internal/external business challenges to facilitate process improvements
- Strong knowledge of statistics, data analysis, and data interpretation
- Has significant experience working independently and collaborating with multiple functional groups within and outside the business line
- Has demonstrated an advanced ability and level of experience with working across multiple studies for incorporation of consistent medical/scientific concepts in multiple protocols and ensuring they meet strategic program objectives
Eligible for Relocation Package
Eligible for Employee Referral Bonus
#LI-PFEPfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.Sunshine Act
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