Pharmacokineticist I - Bengaluru, India - Labcorp

Labcorp

Verified Company

Bengaluru, India

3 weeks ago

Posted by:

Deepika Kaur

beBee Recuiter

Description

As a leading contract research organization (CRO), Labcorp Drug Development provides comprehensive drug development solutions for a range of industries.

Our services cover the preclinical, clinical and post-market phases of drug development, the product life cycles for medical device and diagnostics and development services paired with regulatory support for the chemical testing and crop protection industries.

Labcorp Drug Development is a global leader in nonclinical safety assessment, clinical trial testing and clinical trial management services. Our unique perspectives are based on decades of scientific, medical and regulatory expertise.

Did you know?

Job responsibilities

Liaise with the relevant bioanalytical departments over the transfer and quality of PK and PD data.
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 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 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.
Represent Pharmacokinetics in internal and external audits.
Perform other duties as requested by management.

Minimum Experience:

Bachelors degree in Bioanalytical Chemistry or a Biological Life Science field
Proficient in compartmental/noncompartmental data analysis
Proficient in PK/PD analysis tools WinNonLin and NONMEM
Effective interpersonal and communication skills
Cooperative, teamoriented and proactive
Selfmotivated
Ability to work in tight deadlines while maintaining high quality standards
Ability to adhere to strict guidelines and codes of practice

-
Good knowledge of Clinical Development

Competence in the preparation of Pharmacokinetic Analysis Plans, reporting, etc., across a variety of trials
Ability to explain PK and PD concepts to nonpharmacokineticists
An evident appreciation of the possible impact of daytoday activities and actions on company as a business.

Labcorp is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind.

We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic.

We encourage all to apply.

For more information about how we collect and store your personal data, please see our Privacy Statement.