As a member of the Clinical Assay Group within Global Clinical Pharmacology, Clinical Assay Lead will play a critical role in supporting clinical strategies in all stages of drug development and post marketing activities through scientific and technical oversight and management of external and internal partners involved in delivering quality, timely, and regulatory compliant PK, PD bioanalytical assays and data.ROLE RESPONSIBILITIES
- Serves as a member of the clinical study team and bioanalytical subject matter expert for executing clinical study setup & conduct, contributing to the study protocol development & review, preparing submissions, addressing regulatory queries, implementing bioanalytical strategies & assays, and delivering regulatory compliant data and reports within program timelines.
- Leads and oversees small molecule PK, PD assay lifecycle management from early stage to registration encompassing analytical 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.
- Functions as key point of contact with external & internal laboratories and supports selection, qualification, performance evaluation, and periodic audits of CRO laboratories conducting clinical PK assays.
- Supports the clinical trial conduct within scope of the Clinical Assay Group responsibilities, including development and review of documents and processes such as CRF and data setup, clinical site lab manual, sample management & reconciliation, bioanalytical study planning & reporting, budgeting & invoicing, compliance with clinical SOPs & policies, and regulatory inspection readiness & conduct.
- Contributes to the development of Best Practices processes, templates, and policies.
- Maintains up-to-date knowledge of current and novel chromatographic separation/mass spectrometry based detection technologies & techniques, global regulatory guidances & expectations, and industry best practices.
- B.S. plus 9+years experience in relevant industry experience.
- Masters degree plus 7 +years experience in relevant industry experience.
- PhD or equivalent plus 4+ years experience in relevant industry experience.
- Minimum of 5 years of industry or bioanalytical experience with PK assay (including endogenous analytes) development, validation, and sample analyses using chromatographic/mass spectrometry methodologies.
- Working knowledge of GxP regulations governing conduct of clinical trials and regulatory guidances and expectations relevant to regulated bioanalysis.
- Demonstrated ability to think strategically, work in a highly matrixed environment, and execute multiple projects simultaneously.
- Highly effective communication skills: verbal, written, and presentation.
- Hold Degrees in analytical chemistry/chemistry or biology or relevant areas.
- Hands-on experience with the development, validation and troubleshooting of the methods for LC-MS/MS quantitation. Particularly, experience with separations of challenging analytes using various chromatographic techniques, in-depth knowledge of sample preparation including 2D-LC and expertise on various mass spectrometry detection platforms and their application in clinical sample analysis.
- Experience with, human ADME, protein binding, immunocapturing hybrid assays and technologies such as LC-AMS and HRMS.
- Demonstrated CRO management and outsourcing experience.
- Experience with regulatory inspections.
- Experience preparing regulatory submissions and addressing regulatory queries.
- Basic understanding of clinical trial design and overall principles of clinical development and related disciplines (e.g., pharmacokinetics and clinical pharmacology, statistics, ADME, formulation and drug product).
RESOURCES MANAGED Financial Accountability
- Reports to Small Molecule Group Lead, Clinical Assay Group within Global Clinical Pharmacology.
- Frequent interaction with colleagues in Global Clinical Pharmacology, Clinicians, Medicines Design (PDM), Contract Research Organizations (CROs), Clinical Operations, Statistics, Regulatory, Finance, and external collaborators, as appropriate.
- Member of Clinical sub-teams and study teams.
- Indirect responsibility for the clinical budget allocated to bioanalytical support of the clinical study or program.
- Develop bioanalysis agreements with commercial and academic laboratories.
- Responsible for approval of invoices for work overseen.
Individual contributor, no direct reports.
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
NANON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Due to the need to support global operations, the employee may be required to attend teleconference meetings at non-regular work hrs.
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.Pfizer 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
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.