ROLE SUMMARY

This position provides regulatory compliance, technical and operational oversight to the implementation of a full range of ADME, pharmacokinetic, regulated bioanalytical and specialty outsourced studies supporting clinical asset development across all stages of drug development including post-marketing. Key activities include vendor oversight, sample, data, and document management to ensure delivery of high quality, timely, regulatory compliant bioanalytical (BA) assays,  Toxicokinetic (TK) data and other specialized ADME studies. A successful candidate is well organized, can communicate effectively, has a broad knowledge of ADME studies, as well as technology platforms such as  mass spec or NMR and regulatory requirement for validation of such assays, and can work both independently and collaboratively in teams. Core responsibilities will include managing outsourced IND and NDA enabling BA/TK programs towards successful delivery of method validation, facilitation of method transfer, study coordination, sample analysis and reporting, study monitoring for regulated nonclinical safety studies.  Duties also include technical evaluations of new vendors, onboarding vendors, SOP reviews and management/oversight of all regulatory, bioanalytical and logistical aspects of the studies towards successful completion of deliverables.  Colleagues contribute into regulatory filings and provide SME support on regulatory query responses.   

At the senior manager level, colleagues are expected to maintain a higher level of awareness around Pfizer SOPs and to be engaged with the global bioanalytical community at Pfizer.  They are a subject matter experts on mass spectrometry and provide bioanalytical troubleshooting for regulated nonclinical safety studies in collaboration with the vendors.  They willingly take on leadership roles related to refining our processes and/or engaging the vendors for the types of assays and studies needed and are accountable for managing outsourcing budgets for vendors within their assigned scope of responsibility.

ROLE RESPONSIBILITIES

• Active member of the nonclinical PDM project team as the bioanalytical SME.  Contributes to protocol designs, is responsible for assay development/ validations and sample analysis/reporting ensuring compliant data, reporting under project timelines and responding to regulatory queries.

• Leads and oversees small molecule bioanalytical assay lifecycle, management from early stage to registration encompassing executing analytical strategy, development and method design, validation, data quality review, corresponding sample analyses & reporting to meet evolving program objectives and regulatory expectations. Assists CROs with effective troubleshooting of the bioanalytical assay and issue resolution.

• Strategically identify sourcing partners, perform vendor evaluation, relationship/contract development and management, performance evaluation as well as periodic audits of laboratories, bioanalytical and toxicokinetic data at CROs.

• Technical assay transfer, project management, cross-site and cross-discipline coordination with internal Study Directors, PDM project representatives, CRO PIs,  PDM bioanalytical members, and others as needed to ensure timely execution of studies.

• Finance reporting of outsourcing spend at each vendor relative to budgetary targets and capturing metrics on quality, workload, timelines for performance score cards and strategic adjustments to sourcing strategies.

• Continuous improvement in productivity and work process development and optimizations.

• Regulatory guidance on local, regional and international regulations and FDA/ICH guidance documents and maintenance of departmental SOPs/best practices in accordance with these regulations for both nonclinical and clinical assay conduct

• Review of deliverables (data, validation and study reports, SEND datasets) for compliance with procedures and regulations,  adequacy of quality and achievement of acceptance criteria.

• Adhering to and managing timelines to ensure timely analysis and reporting of bioanalytical and TK data.

• Provide timely and high quality regulatory responses on queries related to methods or bioanalytical data/results.

• Additional responsibilities and activities may also be involved commensurate with business need and incumbent’s capabilities. Technical Skill requirements:

• Experience interacting and coordinating outsourced studies for regulated bioanalytical, setting-up contractual work agreements, and managing CRO priorities and timelines.

• Strong knowledge of LC/MS assays as to enable the development of novel or complex assays with a strong understanding of method development processes, acceptance criteria and incurred sample reanalysis for regulated studies/compounds.

Experience with, human ADME, protein binding, immunocapturing hybrid assays and technologies such as LC-AMS and HRMS.

• Strong knowledge of regulatory requirements including FDA/ICH Guidance for Bioanalytical Method Validation, Good Laboratory Practices  and Standards for the Exchange of Nonclinical Data

• Demonstrates strong business acumen - knows how businesses work; knowledgeable in current and possible future policies, practices, trends, technology, and information affecting his/her business and organization; knows the competition; is aware of how strategies and tactics work in the marketplace.

  

Qualifications

BASIC QUALIFICATIONS

•  B.S. minimum of 8 yrs, M.S. + 5 yrs, relevant job experience

• Relevant experience includes bioanalytical/metabolism Pharma experience using mass spectrometry, SM/LM/ADC

• Working knowledge of regulatory requirements (i.e., GLPs)

PREFERRED QUALIFICATIONS

• Industry experience
• Demonstrated problem-solving skills
• Ability to manage and contribute effectively to multiple projects at once
• Highly effective verbal and written communication skills
• Proven track record in Pharmacokinetics, Dynamics and Metabolism or like function.
• Team Player

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

15% travel

Work Location Assignment: On Premise

The annual base salary for this position ranges from $99,900.00 to $166,500.00. 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.

Medical

#LI-PFE