Nonclinical Drug Development Strategist - Pharmacology, Pharmacokinetics, Toxicology
Mary Bolt at CK Science is recruiting for a Nonclinical Drug Development Strategist - Pharmacology, Pharmacokinetics, Toxicology to join a leading, global, full service CRO at their site based in Central London on a permanent basis.
The Company:Our client is an expanding global CRO, providing expert support across all stages of the clinical trial process and a wide range of therapeutic areas in the Biotech, Pharma and Medical Device industries.
The role is based at our client's site in Central London which is easily commutable with links to multiple tube stations as well as being close to a range of restaurants and cafes overlooking the River Thames.
Your main duties will be to:
- Be responsible and accountable for the development and execution of global nonclinical strategy in support of RA project team goals as well as acting as the nonclinical point-of-contact within the RA project team, company and with Sponsors to provide end-to-end support and guidance within the contracted scope of the project.
- Seamlessly collaborate with the project manager, project lead, other SMEs, medical writing, and regulatory publishing to deliver world-class RA strategy and execution and maintain up-to-date knowledge and understanding of global regulatory requirements, guidance, conventions, and technologies as it applies to nonclinical drug development strategy.
- Lead the development of nonclinical summary documents including Module 2.4 and 2.6 documents for INDs, NDAs, BLAs, and MAAs, as well as the nonclinical sections of other regulatory documents, including briefing documents, Investigator's Brochure, waiver requests, whitepapers, literature, and protocols as needed.
Further responsibilities will include:
- Ensuring that all nonclinical documents and document sections are completed within the agreed upon timelines and developed with full compliance to all internal review and quality control processes.
- Responding to Regulatory Authority nonclinical queries and participating at meetings and teleconferences with Regulatory Agencies as needed as well as representing RA on relevant bid defenses and general capabilities discussions and providing nonclinical expertise to RA senior management in support of Sponsor interactions to meet business targets.
- Function as RA project lead on RA projects as needed assuming responsibility and accountability of project success, delivering scientific leadership in conjunction with other SMEs, and demonstrating effective communication with the project team and with the Sponsor.
The ideal candidate for this role will have:
- Educated to degree level or above (MSc, PhD etc.) in life science or a related field with Pharmacology, Pharmacokinetics or Toxicology experience in the CRO, Biotechnology, or Pharmaceutical industries.
- Direct experience of working on multidisciplinary drug development project teams and comprehensive knowledge of drug development strategy as well as demonstrated experience of writing or contributing to the development of nonclinical summary documents including Modules 2.4 and 2.6 of INDs, NDAs, BLAs, etc. or nonclinical sections of regulatory documents including briefing documents, Investigator's Brochures, study waivers, whitepapers, etc.
- Excellent communication (both written and oral) and interpersonal skills to positively influence internal and external teams and the ability to work independently with little to no guidance as well as the ability to act as a team player.
For more information or to apply for this position, please contact Mary Bolt on 01438 768717 or email firstname.lastname@example.org. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 46341 in all correspondence.