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Clinical Biomarker Senior Director

Company: Amazon Workforce Staffing
Location: Cambridge
Posted on: September 17, 2020

Job Description:

Company: Proclinical Group

Location: Cambridge

Posted on: September 12, 2020

Job Description:

You are here: Home > Clinical Biomarker, Senior Director

Discipline: Clinical Research Associate (CRA), Project/StudyManager (CSM/CPM), Program Manager / Director

Location: United States

This vacancy has now expired

Proclinical is currently recruiting for a Clinical BiomarkerSenior Director with a leading biotechnology company located inCambridge, MA. Successful candidate will liaise with external assaylaboratories, collaboration partners and CROs. This position willwork collaboratively across several disease teams and associatedcompounds to ensure planning, execution and data delivery of thebiomarker strategy for clinical trials conducted by the company andwill manage a team of direct and indirect reports.

Job Responsivities:

Develop the biomarker strategy with input from the research andclinical leads for the study.

Drive the biomarker strategy to ensure assay labs completeappropriate qualification or validation work in order to execute onthe clinical biomarker plan on time and with good quality.

Ensures the timely and efficient delivery of all biomarkeroperational aspects across therapeutic area clinical trials.

Accountable for planning, coordinating, and overseeing alloperational activities required to manage the flow of biomarkersamples from planning, collection, analysis, data delivery andfinal sample disposition.

Responsible for collaborating closely with TranslationalScience/Research and Biosample leads to execute biomarkeroperational strategies, serving as a single point of contact forbiomarker operations across teams, and with collaborators, assaylabs and CROs.

Responsible for the identification and selection of biomarkervendors in collaboration with the Translational Science/Researchleads.

Ensure collection, delivery and analysis of biosamples accordingto the protocol and in compliance with protocol, informed consent,local regulations as well as GCP/ICH.

Manages the development and oversight of the biomarker analysistimelines, budget, risk and quality plans.

Leads the development and finalization of the Biomarker Planbased on input from scientific and operational team members todeliver on biomarker operational strategies.

Develops and provides operational input and recommendations intoall study related documentation (including protocol, informedconsent form, and amendments) and processes.

Attends operations team meetings and monitor training, CROkick-off meetings, as applicable, to deliver trainings onbiomarker.

Participate in committees and work streams that support processand procedure for standardized language, biomarker usage, and datareporting.

Skills and Requirements:

MS (8+ years pharmaceutical/biotechnology experience) or PhD(with at least 5 years of pharmaceutical or biotechnologyexperience) in a related science focus (i.e. immunology, molecularbiology, biotechnology).

Experience in clinical translational or biomarker work and itsrole across drug development from early phase throughlicensure.

Solid experience in the application of biomarkers duringdevelopment of assets is preferred, including experience withclinical translational research, validation and implementation.

Experience in managing third party assay laboratories,collaborations and budget management.

If you are having difficulty in applying or if you have anyquestions, please contact Max Robinson at (+1) 929-388-1651 orm.robinson@proclinical.com .

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

Proclinical Staffing is an equal opportunity employer.

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By submitting this form, you consent to allow Proclinical tostore and process the personal information above and sendcommunications to you to provide the information and/or servicesyou have requested. For information on how to unsubscribe, as wellas our privacy practices and commitment to protecting your privacy,check out our Privacy Policy .

Keywords: Proclinical Group, Cambridge , Clinical Biomarker, Senior Director, Other , Cambridge, Massachusetts

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