Sr. Director, Vaccines Clinical Scientist, RSV Asset Lead
Sr. Director, Vaccines Clinical Scientist, RSV Asset Lead
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$ 204700 - 341100
1 Vacancy
Job Description
ROLE SUMMARY
The Clinical Scientist (CS) provides leadership in conduct of observational study execution including epidemiological non-interventional pragmatic and low-interventional studies and research collaborations to ensure consistency of approach conduct monitoring analysis reporting oversight of core team activities and best practices to deliver both clinical and operational excellence within one or more programs in the Therapeutic Area (TA). The Sr. Director CS may also have one or more direct reports/contractors to manage for their execution of studies within the specified product or disease area.
In collaboration with cross functional colleagues the CS is responsible for execution and project management of their studies as well as oversight of studies executed by CSs supporting the product. The CS collaborates with other Pfizer groups and oversees vendors to execute the studies. The CS is responsible for numerous observational and epidemiological studies run as Pfizer-sponsored and/or as non-Pfizer sponsored Research Collaborations.
The CS has a significant role in partnership with Medical Evidence Generation (MEG) Medical Affairs Statistics Clinical Data Sciences Statistical Data Sciences & Analytics and external team members where applicable and other team members on development of operational plans and provides input on tactical implementation of studies to support the asset strategies in line with Pfizer SOPs. As co-lead of the Study Core Team the CS leads via a matrix organization to execute studies.
This position is specifically for a Vaccines RSV Asset Lead CS role.
ROLE RESPONSIBILITIES
Serve as Clinical Scientist Lead for a given product in the category with asset level responsibility in addition to managing studies
Responsible for leading end to end numerous studies across various SOPs including tasks related to: 1) protocol and protocol specific training 2) vendor management 3) study level planning and oversight 4) data review 5) regulatory document study report and publication preparation and review and 6) overall study execution with a critical focus on consistency quality data integrity safety and alignment with company processes.
Works in a global environment on studies across all regions.
Represents the line in program-wide functions and governance as needed. Contributes to discussions to ensure consistency across products/TA.
May provide line management support for other Clinical Scientists within the program. Reviews work develops staff 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 epidemiologic/observational and TA specific aspects of trials provides oversight of operational strategic partner involvement at a program or study level. Identifies issues in a timely manner leads implementation of complex solutions and/or escalates as appropriate.
Influences management/senior staff decisions and is viewed as the Subject Matter Expert on CS decisions impacting a study/program.
Provides CS leadership role in preparation of regulatory submissions responses to regulatory queries and in preparation for program regulatory inspections and audits.
In collaboration with MEG and Medical Affairs colleagues present and discuss data at relevant team governance external consultants KOLs and potentially regulatory meetings.
Contribute/champion R&D initiatives process improvement initiatives and/or solutions for complex issues.
BASIC QUALIFICATIONS
Training and Education
BA/BS Degree in life sciences or health related field with 12 years practical experience or MS/MBA with 10 years PharmD/PhD 7 years and MD/DO with 5 years.
Prior Experience and Capabilities
Significant years of strong hands-on experience in study design conduct and analysis.
Experience working on global teams/studies
Ability to work independently and collaborate with multiple functional groups within and outside (e.g. outside CROs/vendors) company
Demonstrated advanced ability and level of experience with working across multiple studies for incorporation of consistent medical/scientific concepts in multiple protocols
Extensive knowledge of the clinical research process and Good Clinical Practices (GCPs) monitoring clinical and regulatory operations
Solid knowledge of therapeutic area
Demonstrated independent authorship of study protocols and other study documents
Working knowledge of statistics data analysis and data interpretation
Experienced in managing external vendors for clinical and/or epidemiological study(ies)
Skills
Has exceptional written and oral communication and cross-functional collaborative skills
Ability to influence and collaborate with peers
Strategic thinking and targeted problem-solving skills
Ability to leverage negotiate and resolve conflicts to enhance team performance and delivery
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.
NON-STANDARD WORK SCHEDULE TRAVEL OR ENVIRONMENT REQUIREMENTS
Position requires travel (10%) includes domestic and global travel. Weekend and evening work likely to be required based on project needs as needed but the exception rather than rule.
Work Location Assignment:Hybrid
Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care providers name address and the type of payments or other value received generally for public disclosure. Subject to further legal review and statutory or regulatory clarification which Pfizer intends to pursue reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse your name address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter please do not hesitate to contact your Talent Acquisition representative.
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.
Required Experience:
Director
Employment Type
Full-Time
