The Clinical Assay Lead plays a critical role in delivering quality and compliant PK, PD, and immunogenicity bioanalytical assays and data through all stages of clinical biotherapeutic drug development and applicable post marketing activities. This is achieved through scientific and technical leadership, external and internal laboratory partnerships, clinical trial execution, and submission support.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 and review, preparing submissions, addressing regulatory queries, developing and implementing bioanalytical strategies & assays, and delivering regulatory compliant data and reports within program timelines.
- Leads and oversees large molecule PK and immunogenicity (ADA and Nab) 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. Guides and leads study teams with respect to the selection and execution of the analytical strategy.
- Functions as key point of contact with external & internal laboratories and leads selection, qualification, performance evaluation, periodic visits and audits of CRO laboratories conducting clinical PK, PD, and Immunogenicity assays.
- Leads development of novel complex methodologies, troubleshooting & resolution of complex technical & logistical issues with vendors and study teams. Identifies technology/capabilities gaps and proposes mitigation strategies including development of novel technical capabilities with vendors. Scientifically evaluates complex data (i.e. evaluates aberrant results and data trends), anticipates and corrects potential issues, and able to appropriately guide study teams through complex issues resolution.
- Supports clinical trials and programs involving novel modalities, cross-company collaborations, and/or external partnerships in addition to Clinical Assay Group study responsibilities, which include 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.
- Leads internal and cross-functional organization initiatives, best practices and demonstrates internal and external influence.
- Provides subject matter expertise, guidance and mentoring to colleagues. May have responsibility for dotted/direct line management of staff.
- PhD or equivalent in biology or analytical chemistry/chemistry with 5+ years of industry or bioanalytical experience with PK and/or immunogenicity assay development, validation, and sample analyses using ligand binding (ELISA and ECL) methodologies, Master's degree with 7+ years OR Bachelor's degree with 9+ years.
- Expertise in development, validation and troubleshooting of complex methods for PK and immunogenicity assessment (including the determination of assay cut points, tolerance, and sensitivity along with experience implementing ACE, BEAD, and SPEAD methodologies and in clinical sample analysis.
- In depth knowledge and ability to provide interpretation of GxP regulations governing conduct of clinical trials and regulatory guidances and expectations relevant to regulated bioanalysis.
- Experience preparing regulatory submissions and addressing regulatory queries.
- Demonstrated ability to think strategically, work effectively in a highly matrixed environment, and execute multiple projects simultaneously.
- Demonstrated CRO management and outsourcing experience.
- Understanding of clinical trial design, overall principles of clinical development, and related disciplines (e.g., pharmacokinetics and clinical pharmacology, statistics, immunology, human ADME, formulation and drug product).
- Strong understanding of critical reagent generation & lifecycle management.
- Highly effective communication skills: verbal, written, and presentation.
- Recognized subject matter expert in regulated bioanalysis and understanding of bioanalytical techniques commonly used for Biotherapeutics.
- Experience with biosimilars, gene therapy, multi-domain therapeutics, human ADME, immunocapture, protein binding, cell based assays and technologies such as RT-PCR, qPCR, ELISPOT, and FACs.
- Direct experience interacting with regulatory authorities and supporting regulatory inspections.
- Experience training, mentoring, and/or supervising colleagues.
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.Relocation support available
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
Work Location Assignment: FlexiblePfizer 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.