Global Clinical Pharmacology Director
Mid-size pharma client in North London with a global outreach looking for an experienced CMC/DMPK specialist
> Ability to work in the UK - full right to work
> Strong experience as a clinical pharmacology study director
> Global experience - solid knowledge of the global regulatory processes/bodies
> In this role you will work to direct the clinical study strategy from a scientific stand point, designing the critical pharmacology studies on a global scale. Despite the role being European based, this position is not limited to European submissions and thus, it is preferred if candidates have experience across U.S, Europe & Asian markets.
> The role will replace the current director and is open to an Associate Director stepping up into the position.
• You would provide scientific leadership on global Clinical Pharmacology (CP) strategy and executing the CP program as CP representative of projects; developing CP part of Clinical Development Plan/Drug Development Plan, identifying CP studies required for NDA/BLA filing, leading CP contributions to all regulatory documents (including authoring CTD module 2.7.2)/reviews/responses while managing strict timelines.
• Designing and directing CP studies as study director; developing protocol concept sheets and protocol, driving the execution of the protocol with close collaboration with study team members, interpretating results and delivering the clinical study report.
• Conducting PK and PK/PD data analysis; interpreting PK and PK/PD results for the project teams.
• Managing BA activities locally and globally: developing BA global strategy to meet future needs and improve efficiency; reviewing bioanalytical plans and reports to ensure that the reports meet current/future regulatory requirements.
• Maintaining and improving BA and PK service deliverables to project teams. Assuring quality and timeliness to project teams.
• Oversee BA/PK services for outsourced studies – in particular to maintain consistency across outsourced CROs.
• Improve systems and process as appropriate for optimal efficiency and quality for all global clinical BA and PK work.
• Contributing to global CP/BA/PK team; joining/contributing to meetings, sharing ideas on innovation in technology, methodology which can improve timelines, quality or cost-effectiveness in the CP/BA/PK area.
Interested in hearing more? Contact Tom Hancox on +44(0)207 822 1710
- Agency: Cpl Life Sciences
- Reference: JO-2205-492104
Website: Cpl Life Sciences
- Posted: 8th June 2022
- Expires: 6th July 2022