Clinical BA

Highly Competitive
  1. Permanent
  2. Biological Sciences
  3. China
Shanghai
Posting date: 07 Aug 2019
SC.LZ.24719_1565191891

An internationally renowned pharmaceutical organisation is seeking to hire a Clinical BA for their office in Shanghai. This historic company, which has been established for well over a century, prides itself on its work across multiple therapy areas, including cardiovascular, neurology, and immunology. This is an exciting opportunity to work with one of the most prestigious pharmaceutical establishments in the world.

Job Responsibilities:

  • Serves as a member of the clinical study team and analytical subject matter expert for executing clinical study setup & conduct, contributing 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 or large molecule PK, PD, and immunogenicity (ADA and Nab) assay and biomarker assay lifecycle management from early stage registration.
  • Analytical strategy execution, method design, development, and validation, as well as data quality review will be involved.
  • Corresponds sample analyses & reports 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 (or leads, as appropriate) selection, qualification, performance evaluation, and periodic audits of CR laboratories
    conducting clinical PK, PD and immunogenicity assays (as relevant to the role).
  • 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 the development of Best Practices, processes, templates, and policies.
  • Maintains up-to-date knowledge of current and novel chromatographic separation/mass spectrometry-based detection, ligand binding technologies & techniques or bioanalytical techniques commonly used for Biomarkers (as relevant to the role), global regulatory guidances & expectations, and industry best practices.

Skills and Requirements:

  • PhD or equivalent in biology or analytical chemistry/chemistry. M.S. degrees will be considered based on relevant industry experience
  • PhD with 5+ years or M.S. with 8+ years of industry or bioanalytical experience with PK and/or immunogenicity assay and biomarker assay development, validation, and sample analyses using chromatographic/mass spectrometry, ligand binding (ELISA and ECL) or other methodologies like flow cytometry, FISH and etc. (as relevant to the role).
  • Working knowledge of GxP regulations governing conduct of clinical trials and regulatory guidances and expectations relevant to regulated bioanalysis.
  • Subject matter expert in regulated bioanalysis small organic molecules or Biologics and understanding of bioanalytical techniques commonly used for Biomarkers.
  • In depth knowledge of GxP regulations governing conduct of clinical trials and regulatory guidances and expectations relevant to regulated bioanalysis.
  • Demonstrated CR management and outsourcing experience.
  • Experience with regulatory inspections.
  • Experience preparing regulatory submissions and addressing regulatory queries.
  • 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).
  • Prior experience with training, mentoring or managing colleagues.
  • 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.
  • Hands-on experience with the development, validation and troubleshooting of the methods for PK and immunogenicity (including the determination of assay cut points, tolerance, and sensitivity along with experience implementing ACE, BEAD, and SPEAD methodologies) and clinical sample analysis.
  • Understanding of critical reagent generation & lifecycle management
  • Experience with biosimilars, gene therapy, multi-domain therapeutics, immunocapture, protein binding, cell-based assays and technologies such as RT-PCR, qPCR, ELISPOT, AMS and FACs.
  • Hands-on experience with the development, validation and troubleshooting of the methods commonly used for Biomarkers, including but limited to flow cytometry, FISH, IHC, and NGS.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Lily Zhao at +86 21 51694106 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

#LI-148632573_桃赵1

#Scientific

close