Pharmacokineticist I

**Pharmacokineticist I**:
Fortrea’s Clinical Operations team is recruiting for a Pharmacokineticist. You will join a global team and have the opportunity to work across a number of compounds across Phase I studies. In a versatile opportunity, you will work closely with a variety of different Sponsors, being responsible of Pharmacokinetic deliverables across a number of projects.

We are looking for a Pharmacokineticist / Clinical Pharmacologist who will be involved in reviewing study designs, providing input to Statistical Analysis Plans, performing/reviewing PK/PD data analyses and providing accurate interpretation of data. You will also contribute to project management activities and have the opportunity to assist with proposal activities.

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?**:
**Duties will include**:

- Provide PK(PD) guidance and consultancy in development of clinical research program and in design of individual studies as part of multi-disciplinary 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 data-handling 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 non-compartmental 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 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.
- Represent Pharmacokinetics in internal and external audits.
- Supervision and training of less-experienced Pharmacokineticists within project activities.
- Contribute to proposal activities and client presentations.
- Provide PK(/PD) guidance and consultancy in development of clinical research program and in design of individual studies as part of multi-disciplinary team.

**Ideally you will have the following experience/skills**:

- Bachelor’s degree in Bioanalytical Chemistry or a Biological Life Science field.
- Proficient in compartmental/non-compartmental data analysis.
- Proficient in PK/PD analysis tools WinNonLin and NONMEM.
- Effective interpersonal and communication skills
- Cooperative, team-oriented and proactive.
- Ability to work in tight deadlines while maintaining high quality standards.
- 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 non-pharmacokineticists
- An evident appreciation of the possible impact of day-to-day activities and actions on company as a business.

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