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SalaryROLE SUMMARY
- The Vendor Strategy Category Director will serve as the single point of business accountability in Clinical Development and Operations to support strategic sourcing, vendor selection, assessment, onboarding, and monitor performance of vendors in Oncology Regulatory and Medical Affairs Strategy
- Serve as point person for stakeholders across the organization as well as to the relevant vendors.
- Works closely with colleagues in CD&O Regulatory and Oncology Medical Strategy to ensure outsourcing requirements are delivered as defined while ensuring Regulatory Strategic and Medical Affairs vendor scope for all Oncology products are achieved
- Lead and ensure vendor risk management, vendor issues management, and general GCP guidance are maintained for all relevant vendors within these service categories
ROLE RESPONSIBILITIES
- Selection of preferred vendors within the strategic framework for regulatory strategy and medical affairs
- Monitor and support compliance with sourcing and contract adherence
- Ensure appropriate communication and oversight of vendor panel
- Support audit/inspections/litigation readiness and responses
- Oversee risk management of central labs to mitigate volume and impact of issues
- Provide guidance and expertise to teams for required vendor onboarding and engagement activities
- Act as functional line in vendor assessments for applicable operating procedures including but not and onboarding.
- Define and assign curriculum to vendor resources; ensure systems access for vendor resources.
- Core member of governance structure
- Provide technical issue management; partners with study level study management/relevant line.
- Co-Leads with Procurement the MSA and rate card negotiations
- Monitor trends, SQEs, metrics related to time/ quality/ cost.
- Track volume and spend across preferred vendors
- Oversee the maintenance of performance metrics and indicators, issue escalation, CAPAs, remediation plans, and monitoring systemic deficiencies
BASIC QUALIFICATIONS
- Bachelor’s degree is required with 14+ years of clinical trial experience with relevant vendor management experience
- At least 10 years’ pharmaceutical or healthcare industry experience within associated functions (e.g. pre-clinical, clinical operations, clinical systems, finance, R&D or procurement, medical affairs, regulatory affairs)
- Extensive background in clinical trial conduct, global clinical trial operations, and a thorough understanding of the processes associated with project and study management, monitoring, clinical and regulatory operations
- Demonstrated experience and understanding of risk management within clinical trial execution
- Business experience and understanding of vendor engagement and contracting processes
- Good Clinical Practice (GCP), quality systems infrastructure, and 3rd party supplier management experience
- Ability to support document requests and create tools for internal audits, regulatory agency inspections, and litigation
- Excellent analytical management skills
- Demonstrated sound business acumen and judgement
- Models key behaviors of customer focus; integrity and trust
- Deals with ambiguity is creative and has ability to adapt in real-time
- Drives for results, plans, manages and measures work
- Multi-tasking; prioritizing; coping with high work volume
- Ability to meet tight deadlines
- Ability to work autonomously as well as working within a team
- General knowledge of applying continuous improvement tools to business process improvements/business process re-engineering
- Demonstrated experience to manage and improve large complex processes and/or business operating models
PREFERRED QUALIFICATIONS
- An advanced degree is preferred - Master's degree with 12+ years, or a PhD with 9+ years.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- Occasional travel for business/team meetings.
- During exceptional circumstances, need to work non-traditional hours (such as during a regulatory agency inspection)
#LI-PFE
The annual base salary for this position ranges from $149,200.00 to $248,600.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 20.0% 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.
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 provider’s 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.
