Senior Director, PK/ADA Bioanalytical job in Cambridge, USA

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Last Name*

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Job type: Permanent

Discipline: Senior/Director & VP, Biological Sciences, Pharmacology

Location: United States

This vacancy has now expired. Please see similar roles below...

Proclinical is seeking a Senior Director to lead the group responsible for preclinical and clinical ADA/PK assay development/validation and implementation. This role will help lead and build internal laboratory capability for ligand binding, mass spectrometry and genetic assay development of ADA/PK and other associated preclinical assays for our client's portfolio. In addition, this role will lead the selection of strategic partner labs for the use of these assays in clinical trials in keeping with all applicable regulatory expectations.

Job Responsibilities:

Lead a team of dedicated and ligand binding assay (LBA), mass spectrometry laboratory scientists to develop and validate new ADA and PK assays under appropriate guidance/regulations for preclinical study and clinical trial use
Lead the build of a new genetic assay group for PK assay development
Oversee the growth of a bioanalytical laboratory for LBA, mass spec, and genetic assay development and outsourcing for preclinical study and clinical trial use
Lead the assessment of new technology and scientific breakthroughs for use in support of preclinical studies and clinical trials
Represent Quantitative Bioanalytics in governance meetings for all therapeutic and oncology programs, both preclinical and clinical
Responsible to ensure assays are developed in a timely manner and fit the requirements of study teams, the qualification or validation of assays is fit for purpose in preclinical or clinical use, and troubleshoot any issues that come up with the internal labs or external partners
Oversee a growing team of laboratory scientists, as well as oversight of external vendors
Lead the selection of strategic external partners for the company's ADA and PK assay use in preclinical and clinical studies
Participate in committees and work streams that support process and procedure for standardized language, assay usage, and data transfer and collection
Be a senior leader within the clinical development organization and help lead and interpret assay use for preclinical and clinical trial studies, from assay development throughout the assay life cycle

Skills and Requirements:

PhD (with at least 6 years pharmaceutical/biotechnology experience) in leading a bioanalytical laboratory, with clear experience with PK and ADA assay oversight
Experience leading a team of laboratory scientists
Experience with and deep understanding of relevant guidance around PK and ADA assays from regulatory agencies
Experience leading in a matrix environment
Experience with overseeing vendors
Solid experience in the development of complex ADA and PK assays
Experience in managing third party assay laboratories, collaborations and budget management.
Strong communication and project management skills

If you are having difficulty in applying or if you have any questions, please contact Sofia Amark at (+1) 646-367-2764 or s.amark@proclinical.com.

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.

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Salary

US$120 - US$130 per hour

Location:

Cambridge, USA

Ready to bridge the gap between breakthrough science and real-world therapies? Join our client in turning discovering into impact with the pharmaceutical industry!