Director of Clinical Development - Biotechnology (Budapest)

Director of Clinical Development - Biotechnology (Budapest)
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Our partner is a prominent and constatly developing Pharmaceutical company looking for an experienced Director of Clinical Development to join the leadership team of their Biotechnology Business Unit.

Responsibilities:

  • Leading and managing the Biotechnology Business Unit clinical experts from professional and people management point of view
  • Coordinating the design and implementation of clinical programs /clinical studies in support of an overall Clinical Development Plan
  • Overseeing CRO in terms of project-related education of investigators, study site personnel, and study staff related to the medical elements
  • Being in charge of the clinical aspects of the clinical studies in the EU and US
  • Coordinating the design, analysis, interpretation, and reporting of all kind of scientific content protocols and plans, etc.
  • Responsible for clinical trial execution including, data analysis and reporting to prepare documentation required for regulatory and legislative drug approvals
  • Ability to challenge current processes and promote continuous improvement ideas
  • Engage leaders, investigators, cooperative groups and other experts in constructive scientific and clinical dialogue around study design, study conduct and interpretation of clinical results
  • Taking responsibility for the medical elements within CRO selection and RFPs
  • Identification and evaluation of new opportunities: in-licensing and out-licensing activities, due diligence activities and partner relationships
Requirements:
  • 10+ years of relevant clinical development experience in the pharmaceutical industry
  • Demonstrated experience leading successful development of complex drug therapies
  • Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials
  • Experience in development of clinical strategy and the design of study protocols
  • An M.D. (Medical Doctor) or PhD (natural sciences) qualification
  • A proven success record in biologics/biosimilars research studies and trial design as well as the successful submission of IND’s
  • Strong execution skills, project and people management experience
  • Fluent English (Hungarian is an advantage)
  • Ability to travel occassionally domestically and internationally
  • To be a well-organized manager, an effective team builder and an influential collaborator
What we offer:
  • Being a significant part of an innovation-driven pharmaceutical company and challenging international projects in the field of biotechnology with over a hundred years of experience
  • Get engaged into wide array of projects covering the entire value chain of drug candidates
  • Be a member of a growing team with an international and highly experienced management
  • Competitive salary and wide range of benefits package
  • Flexible working hours
  • Join a company with great reputation and a global footprint

 

Budapest

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