Senior Bioscientist

Proclinical is seeking a Senior Bio scientist to be based in Cambridge on a contract basis. The Scientific Study Monitor Associate Principle Scientist is responsible for monitoring DMPK ADME work that is conducted within external contract research organizations (CRO). He/she will ensure timely delivery of high quality experimental data for all outsourced studies to enable effective decision making and successful regulatory submission and registration.
He/she maintains an in-depth knowledge of state-of -the-art principles and scientific theories. The Senior Scientist displays leadership by scientific influence. He/she can author scientific publications in peer reviewed journals and make presentations at scientific meetings. He/ She will be expected to represent the company with our preferred partners and other bespoke partners (if appropriate) and build good working relationships, whilst at the same time, ensuring that personal integrity and high ethical standards are met.

Job Responsibilities:

• Perform the role of Study Monitor across all types of ADME DMPK studies including in vivo pharmacokinetics, QWBA, mass balance and transporter studies.
• Provide expert and independent contribution to the design, conduct, analysis of the studies and interpretation and contextualization of the study results
• Ensure that study protocols and reports are appropriately reviewed and approved in consultation with the DMPK project lead and CRO responsible person
• Monitor for scientific integrity, quality and timeliness, including potential visits to assess the facilities, staff and raw data
• Maintains a thorough understanding of the DMPK needs to support IMED scientists
• Responsible for keeping other relevant contacts updated about the progress of outsourced work
• Facilitate the sharing of relevant scientific information between the company laboratory staff and relevant CRO staff
• Organise logistical aspects of study including test item supply, appropriate documentation and shipment / return of samples where appropriate
• To ensure all work conducted externally meets relevant standards (e.g. GLP)
• Ensure that relevant documentation is filed and accessible in company systems
• Ensure compliance with all relevant corporate policies
• To build an awareness of current scientific development relevant to a particular area of pharmacokinetics
• To contribute to the continuous improvement process by identifying opportunities in the workplace where improvements can be made
• To use judgment and knowledge where appropriate to influence the work of the project, team, section and department
• To participate in and contribute to local discipline review groups
• To ensure their own work is conducted in accordance with local Safety, Health and Environment requirements.

Skills and Requirements:

• Ph.D. or corresponding experience in a relevant scientific area with several years of relevant experience in drug development.
• Biofluid and tissue sample analysis
• Analytical techniques e.g. LC-MS/MS, LC-UV, ligand binding
• Has a good, practical, understanding of study design and PK/TK data analysis
• Has a basic understanding of toxicokinetics and pharmacology
• Has a basic understanding of the impact of pharmaceutics on PK
• Experience in both small molecule, large molecule and oligonucleotide drug discovery and development process and familiarity with regulatory principles and guidelines

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Weronika Ficek on +44 203 0789 550 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.