You will lead direct, plan and execute Clinical Pharmacology programs and integrate novel translational biomarkers and quantitative modelling / simulation into clinical development programs for the neuroscience portfolio.
Key duties will include:
– Delivering Clinical Pharmacology strategy for large and small molecules in development and delivering key components of the Clinical Development Plan.
– Design and management of Clinical Pharmacology studies that allow early go / no-go decisions, incorporate innovative clinical development strategies and support competitive drug labels.
– Representing and leading clinical pharmacology contributions for all regulatory documents (Investigator Brochures, NDA meetings, EOP2 meetings etc).
– Recommendation of clinical doses and dosing algorithms.
You will require the following:
– MD or PhD in Clinical Pharmacology, Pharmacokinetics, Pharmacometrics or a related field.
– Experience of interactions with Regulatory Authorities, including direct involvement with a successful major regulatory filing.
– Extensive, industrially based experience of defining and implementing clinical pharmacology strategies.
– Experience of overseeing CROs and consultants.
– A background in neuroscience and translational science will be advantageous.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
For more information or to apply for this position please contact For more information or to apply for this position please contact Jim Gleeson on +44 (0)1438 842973 or email firstname.lastname@example.org
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 CL44177 in all correspondence.