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Project Team Leader, Phase II-III drug developmentRef: mc 23637

Salary:€139000 - €154000 per annum + +12% bonus + great benefits

Added:08 Nov 2018

Region: Europe

Sector: Pharmaceutical

Sub Sector: Clinical Research

An excellent opportunity has arisen to join a leading pharmaceutical company as a Project Team Leader, Phase IIB-III Development. The Project Team Leader, Late-stage drug development, R&D will: *Lead multidisciplinary and cross-organizational project teams *Be responsible for establishing and agreeing a viable project drug development strategy to satisfy Target Product Profile requirements *Provide scientific leadership on different aspects of the project and align relevant team members and experts *Be responsible for preparing data-driven recommendations for management and Joint Steering Committee decisions *Take active part in advisory boards, meetings with regulators and public health officials *Proactively manage collaborations with partners and represent our client - aligned strategy and implementation *Engage with the selection and management of external vendors as needed *Develop and maintain an approved project plan and associated budget *Be accountable for delivering on project plan according to timelines, budget, operational procedures, Quality standards, and for reporting progress to donors *Be responsible for successful transition of projects to the Access and Product Management project leader and continue to serve as a team member *Ensure accuracy of all internal and external communications relating to the project/product Education and Experience: *PhD in life sciences *Minimum 8-10 years of drug development experience at a pharmaceutical or biotech company *Must have >5 years of experience in leading complex cross-organizational projects in late-stage development (phase II and III); registration experience desired *Demonstrated success in positions involving influencing and negotiation *Experience in anti-infective therapeutic area, drug combination development and pediatric therapeutics is desired Title examples> Global Project Lead, Clinical Leader, Regulatory Leader Less> CMC product development leader (focus on clinical) Technical skills required: *Proven ability to successfully lead multiple projects in a drug development environment *Scientific expertise in late-stage drug development with emphasis on clinical and regulatory aspects *Broad working knowledge of non-clinical, formulation development, Chemistry, Manufacturing & Controls (CMC) and other aspects of drug development *Experience in working with market access and product management groups to align drug development strategy with target product profiles *Knowledge of ICH / GCP & GMP guidelines *Fluency in English (oral and written) *Familiar with common computer statistical, technical, and database applications Key People is a specialist international recruitment consultancy with over 25 years' experience of working within the life sciences, biotech, healthcare and CRO industries. Please contact Mark Cussens, Clinical Research Recruiter on Tel: +44 1727 817623 or email: mcussens@keypeople.co.uk Tel: +41 4350 86620 or email: mark.cussens@keypeopleswitzerland.ch Key People is a recruitment company with a reputation for providing good value that's been built up over 20 years. For our candidates, we have developed relationships with thousands of clients nationwide and across Europe, who choose to recruit through Key People, so you'll have a wide choice of opportunities to further your career.

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