Director Clinical Development, USA
Jim Gleeson at CK Clinical is recruiting for an Associate Director of Clinical Development to join a leading global Pharmaceutical company based in the East Coast of the USA.
As Associate Director of Clinical Development, you will be responsible for leading the project planning and operational delivery of a portfolio of late phase drug development activities both locally and globally.
The role is to lead and manage defined clinical deliverables across a broad range of activities. This can include the responsibility to lead complex components of a clinical program such as Life Cycle Management, clinical submission activities, or indication development responsibilities or lead independent work packages or maintenance projects.
- Leading a cross functional team of clinical experts in the planning and delivery of a defined clinical project to scope, quality, budget, time, managing resource and risk
- Programme management including the development, baselining and maintenance of realistic, up to date and appropriate quality, project and study plans
- Input into study feasibility, study specifications, vendor/partner contracts and essential documents such as clinical study protocols
- Act as the company's operational interface with external (e.g. CRO/ARO) partners for externally managed/outsourced studies as appropriate
- Responsible for ensuring timely compliance with companywide governance controls
- May be assigned responsibility for leadership and program/project management of non-drug project work
Minimum Requirements - Education and Experience:
- University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research. Advanced degree is preferred.
- Strong clinical development experience gained within a pharmaceutical company environment
- Extensive knowledge of clinical operations, project management tools and processes
- Global programme management experience
- Experience from leading clinical projects and deliverables or similar expertise from other areas of drug development (such as pharmaceutical development).
- Project management certification is desirable but not mandatory.
- Knowledge of process improvement methodology such as Lean Sigma/Change Management is desirable but not mandatory.
For more information or to apply for this Associate Director, Clinical Development position please contact Jim Gleeson on +44 (0)1438 842973 or email email@example.com. Alternatively, please click on the link to apply online now.
CK Clinical 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 US is essential. Please quote reference CL33491 in all correspondence.