Russell Oakley is currently recruiting for an Associate Director within Oncology for a global pharmaceutical drug developer based in Cambridgeshire. As Associate Director you will be responsible for leading the project planning and operational delivery of clinical work packages in Clinical Operations, GMD. The span of activities is broad covering clinical activities in late drug development, registration/submission and post registration product maintenance phases and will include local and global working.
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. Tasks involve project planning and operational delivery of clinical programmes, and project management of the scope, schedule and budget. In addition to clinical work in drug projects, the ADCD may manage improvement or change projects in other business areas. The ADCD may be aligned to one or more projects depending on size and complexity and is responsible to the Director Clinical Development for the program.
Key responsibilities include:-
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 (e.g. large studies/package of studies, submission planning, regulatory defense, inspection readiness, payer evidence)
Being responsible for project management including the development, baselining and maintenance of realistic, up to date and appropriate quality, project and study plans (including timings and total costs) in agreed systems (such as IMPACT, OPAL and ACCORD)
Providing input into study feasibility, study specifications, vendor/partner contracts and essential documents such as clinical study protocols
Lead a large/complex work package or manage a clinical study and the process to identify and solve operational issues and drive delivery to plan through internal or external partners (Alliance partners, CROs, vendors and Academic Research Organizations).
Acting as an operational interface with external (e.g. CRO/ARO) partners for externally managed/outsourced studies as appropriate
Being responsible for ensuring timely compliance with company wide governance controls (e.g. Sarbanes-Oxley, ACCORD access and study attestations, continuous assurance, Letter of Assurance and Clinical Trial Disclosure)
May be assigned responsibility for leadership and program/project management of non-drug project work
University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research. Advanced degree is preferred.
Significant experience from within the pharmaceutical industry or similar large multinational organisation.
Extensive knowledge of clinical operations, project management tools and processes
Proven experience of clinical development / drug development process in various phases of development and therapy areas.
Proven ability to learn by working in multiple phases, TAs and/or different development situations.
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.
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 CL42971 in all correspondence.
You must be eligible to work in the UK. Learn more
- Agency: CK Group (Science, Clinical, Engineers and IT Recruitment)
- Contact: Russell Oakley
- Phone: 01246 457733
- Reference: CL42971
- Posted: 31st July 2018
- Expires: 28th August 2018