Principal Scientist, Non-Clinical PKPD

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it's the best of both worlds….

ClinChoice is searching for an experienced Principal Scientist to work with one of our partner biopharmaceutical companies. This is a full-time (1 FTE) position, office based in Slough, initially for a 12 month fixed term contract, with the possibility of extension.

The Principal Scientist will sit within the Non-Clinical PKPD group, who are searching for an enthusiastic, communicative, matrix-team operational individual with experience in non-clinical development PKPD, toxicokinetics analysis and reporting.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counter-parts.

Main Job Tasks and Responsibilities:

• Participate in the development of non-clinical PKPD and GLP toxicokinetics studies.
• Lead the non-clinical PKPD strategy.
• Participate in protocol designs and writing by providing scientific support and input into regulatory study designs and protocols.
• Work collaboratively with the project team representatives (e.g. Non-Clinical Safety, Bioanalysis, Clinical Pharmacology) and with the CROs, to ensure high quality data is generated.
• Work under GLP compliance to deliver data packages that meet regulatory standards.
• Effectively communicate with the relevant team members to understand requirements and provide updates to ensure projects timelines are met.
• Analyse and communicate the results of interim and final PKPD/toxicokinetic data analysis to different stakeholders in a timely manner.
• Deliver PKPD study reports and integrated summaries of the studies and participate in regulatory submission documents.
• Facilitate the advancement of drug candidates by building a thorough knowledge of the drug pharmacology and PKPD.
• Represent the interests of the department internally and externally and contribute to enhancing the scientific reputation of Non-Clinical PKPD, Translational Science, and the company.

Education, Experience and Skills:

• PhD/MSc/BSc in a relevant discipline (quantitative pharmacology; pharmacokinetics /pharmacodynamics; DMPK, etc.) with more than 5 years hands on experience in PKPD data analysis within a pharma company or CRO environment.
• Good understanding of pharmacology and pharmacologic processes related to disease and drug mechanisms.
• Demonstrated experience in developing and executing effective non-clinical PKPD studies, and in delivering high-quality data packages for regulatory submissions.
• Experience working in a matrix environment, to help design and set non-clinical PKPD study protocols, and analyze, interpret, and report PKPD results including GLP toxicokinetics studies.
• Hands-on experience in delivering high quality pre-clinical PKPD data analysis. Proficiency in the use of Phoenix- WinNonlin for PKPD analysis is essential. Use of other modelling and simulation packages and tools, such as Berkeley Madonna and/or R would be advantageous.
• Able to handle several projects at any given time, to work successfully in project teams, and to communicate clearly to a variety of audiences.
• Good written and verbal communication skills, and ability to communicate study results and produce high standard reports that meet regulatory submission standards. Record of publications and other external scientific contributions relevant to PKPD will be a plus.

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?
About ClinChoice
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

Key words:
Principal Scientist, PKPD, Toxicokinetics, Pharmacokinetics, Pharmacodynamics, Pharmacology, GLP, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated