Principal Pharmacokineticist - Mississauga, Canada - Labcorp

Labcorp

Verified Company

Mississauga, Canada

3 weeks ago

Posted by:

Sophia Lee

beBee Recruiter

Description

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas.

With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

Did you know?

PK lead for large global or other major projects. Interact and collaborate with internal and external customers to ensure successful project delivery.

To include, but not limited to:

Acting as a source of expertise on all Pharmacokinetics processes. Provide technical solutions and advice to Labcorp staff and to clients on PK(/PD) methodology and principles.
Represent Pharmacokinetics in internal and external audits.
Provide scientific review of PK data analyses and interpretation performed by staff.
Ensure mechanisms in place to maintain flow of appropriate information between disciplines on project team.
Provide PK(/PD) guidance and consultancy in development of clinical research program and in design of individual studies as part of multidisciplinary team.
Fulfill the role of a study Pharmacokineticist:
Responsible for PK(/PD) deliverables within assigned projects.
Review draft protocols for allocated studies to ensure they meet the Sponsors requirements in terms of PK(/PD) analysis and study objectives.
Responsible for development of PK(/PD) Analysis Plans, to include methodology, definition of derived variables, and datahandling rules.
Conduct or review/QC interim PK(/PD) analyses, interpret the data, and attend dose escalation teleconferences to support dose progression in allocated studies.
Conduct or review/QC noncompartmental PK and PD analyses as specified in the report and analysis plans.
Conduct modeling/simulation of PK, PD, and PK/PD data, which may include population PK(/PD) analyses and provide interpretation of the results.
Responsible for PK(/PD) input to reports including Clinical Study Reports.
Independent peer review of PK and PD deliverables (e.g., protocols, Analysis Plans, PK reports, Clinical Study Reports).
Carry out all activities according to appropriate Labcorp SOPs, working within the framework of the Quality Management System and to GCP.
Contribute to review and amendment of departmental processes and supporting documentation. Provide PK input into other disciplines' activities and participate in interdepartmental processes.
Project management activities for identified projects including financial, resource planning and utilization, timelines, and milestone management.
Supervision and training of lessexperienced Pharmacokineticists within project activities.
Contact with client across multiple disciplines.
Contribute to proposal activities and client presentations.

_ Qualifications:
_

Proficient in compartmental /noncompartmental data analysis.
Knowledge of sophisticated PK(/PD) analysis tools such as WinNonLin and NONMEM.
Ability to explain PK and PD concepts to nonPharmacokineticists.
Supervisory skills
Bachelor's Degree in Bioanalytical Chemistry or a Biological Life Sciences Degree required
PhD in Pharmaceutical Sciences or a related field preferred.

US
Pay
Range:
$130,000-$160,000 USD.

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