1+ months

Clinical Assay Lead, Manager

Groton, CT 06340
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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.


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.


Minimum of 5 years of industry or bioanalytical experience with PK assay development, validation, and sample analyses using chromatographic/mass spectrometry methodologies.

Bachelor's Degree required.

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 verbal and written communication skills.


MS with 10+ yrs of experience, or PhD with 5+ yrs of experience.

Hands-on experience with the development, validation and troubleshooting of the methods for LC/MS quantitation, along with experience implementing HPLC/UPLC/GC separation, sample preparation techniques, 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).

**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.

**Other Job Details:**

+ Additional Location Information: Groton, CT and La Jolla, CAEligible for Relocation PackageEligible for Employee Referral Bonus

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Posted: 2019-11-27 Expires: 2020-02-20

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Clinical Assay Lead, Manager

Groton, CT 06340

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