Contract Associate Director, Clinical Development
ProClinical is advertising a vacancy for Contract Associate Director, Clinical Development position with a global biopharmaceutical company. The organisation focuses on developing treatments in the fields of oncology, cardiovascular & metabolic disease (CVMD) and respiratory fields, as well as actively participating in the fields of autoimmunity, neuroscience, and infection. This position offers an exciting opportunity to work with an innovative company whose medicines are used by millions of patients worldwide.
- Responsible for 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)
- 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)
- Provide 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).
- 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 (e.g. Sarbanes-Oxley, ACCORD access and study attestations, continuous assurance, Letter of Assurance and Clinical
- May be assigned responsibility for leadership and program/project management of non-drug project work
Skills and Requirements:
- University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research.
- Advanced degree is preferred.
- At least 10 years' experience from within the pharmaceutical industry or similar large multinational organization.
- 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 click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Matthew Pike on +44 207 440 0639 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Frankfurt am Main, Hessen
An exciting opportunity to work with an international life sciences organisation has arisen, based in the organisation's Frankfurt office.