Oncology Clinical Scientist Lead
Oncology Clinical Scientist Lead
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$ 219800 - 366400
1 Vacancy
Job Description
ROLE SUMMARY
This position is in the Medical Evidence Generation (MEG) Operations department which is responsible for executing endtoend observational studies across all therapeutic areas. The Clinical Scientist (CS) Lead is the leader accountable for oversight and execution of their portfolio comprised of multiple programs and observational studies including noninterventional pragmatic and lowinterventional studies research collaborations and data analyses bringing expertise to the studies in their respective Therapeutic Area (TA). The CS Lead will provide leadership to ensure consistency of approach conduct monitoring analysis reporting and oversight of study team activities in both Pfizersponsored and nonPfizer sponsored Research Collaborations in any region (US Global International). The CS Lead has a significant role in partnership with MEG colleagues Medical Affairs Statistics Clinical Data Sciences Statistical Data Sciences & Analytics and external team members where applicable to develop and implement practical study execution strategies in support of the product plans (e.g. Integrated Evidence Plans finalizing study designs etc.) in line with Pfizer SOPs.
The CS Lead will be responsible for talent development and supervision of Clinical Scientists (CSs) in the group along with mentoring and coaching CSs on their study responsibilities. In addition the CS lead will oversee study timelines the quality and accuracy of data inputs for reporting budgets and quality targets to meet or exceed business needs. The ability to collaborate crossfunctionally and leverage relationships will be instrumental to ensure optimal resourcing as well as the ability to anticipate potential project risks exercise foresight and judgment in initiating planning and guiding study execution.
ROLE RESPONSIBILITIES
Accountable for execution of TA portfolio comprised of multiple programs and observational studies.
Responsible for delivery of end to end numerous observational studies across various SOPs including: 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.
The CS lead will work in a global environment on studies across all regions
Responsible for the identification selection development performance management mentoring/training retention and engagement of a group of up to 8 direct reports/contractors. Responsible for short and longterm resource planning priority setting and filling of resource and skill gaps to address the needs of the program(s).
Represents line on asset teams as needed. Contributes to discussions to ensure consistency across products/TA.
Potential to work at the program/asset or study level and assume CS responsibilities if needed
Using expert knowledge of epidemiologic/observational and TA specific aspects of trials provides oversight of CROs/vendors at a program or study level. Identifies issues/risks in a timely manner leads implementation of complex solutions/mitigations and escalates as appropriate working with MEG colleagues and cross functional partners.
Influences management/senior staff decisions and is viewed as the Subject Matter Expert on CS decisions impacting a program
Collaborates with MEG colleagues and others on development of strategic plans to provide input on tactical implementation of studies to support the asset strategies.
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 the 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 15 years practical experience or MS/MBA with 13 years PharmD/PhD 8 years and MD/DO with 5 years in biopharmaceutical industry. PhD PharmD M.S. or other professional certification preferred.
Prior Experience and Capabilities
Significant years of strong handson global experience in study conduct and analysis.
Significant experience leading study teams.
Significant experience working independently and collaborating with multiple functional groups within and outside (e.g. outside CROs/vendors) company
Demonstrated advanced ability and level of experience 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
Demonstrated 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
Skills
Exceptional communication and crossfunctional collaborative skills
Ability to influence and collaborate with peers
Strategic thinking and targeted problemsolving 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.
PHYSICAL/MENTAL REQUIREMENTS
Lifting sitting standing walking and bending
NONSTANDARD WORK SCHEDULE TRAVEL OR ENVIRONMENT REQUIREMENTS
Position requires up to 15% travel including domestic and global travel.
Work Location Assignment:Hybrid
The annual base salary for this position ranges from $219800.00 to $366400.00. In addition this position is eligible for participation in Pfizers Global Performance Plan with a bonus target of 25.0% 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 lifes 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 (). 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.
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 EVerify employer. This position requires permanent work authorization in the United States.
Employment Type
Full-Time
