Manager of Clinical Development - Biotechnology Field (Budapest)

Manager of Clinical Development - Biotechnology Field (Budapest)
Jelentkezem az állásra ›

If you already have experience in Biotechnology or interested to change your career to Biotechnology field we have an exciting opportunity for you in one of the leading Hungarian Pharmaceutical companies.

Main Responsibilities:

  • Leading and managing the Biotechnology Business Unit clinical expert team
  • Being in charge of the clinical aspects of the clinical studies in the EU and US (including medical monitoring, protocol deviations, data integrity / review, interpretation, communication of accumulating data pertaining to safety and efficacy
  • Managing numerous clinical programs simultaneously
  • Coordinating the design and implementation of one or more 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
  • Preparing and/or reviewing data listings, study results, regulatory documents, IND annual reports, IND safety reports, investigator brochures, and clinical development plans;
  • Overseeing the design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures Clinical Study Reports, ISE, ISS, and paediatric plans as needed
  • 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 thought 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 (clinical/medical/regulatory) of new opportunities: in-licensing and out-licensing activities, due diligence activities and partner relationships
Requirements:
  • 5-10 years of relevant clinical development experience in the pharmaceutical industry, in a global role
  • An M.D. (Medical Doctor) or PhD (natural sciences) qualification
  • The ability to effectively support a global scientific business strategy through communication
  • Profound knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials
  • Experience in development of clinical strategy and the design of study protocols
  • Strong execution skills, project and people management experience
  • Track record in research studies, trial design and successful submission of IND’s
  • Fluent English
  • Ability to travel occassionally domestically and internationally
  • To be a well-organized manager, an effective team builder and an influential collaborator
  • Experience in Biotechnology is an advantage but not a must
What they 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
  • 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
  • Joining a company with great reputation and a global footprint

Budapest

Küldjünk emailt, ha hasonló hirdetés kerül az oldalra?

Ne maradj le egy jó állásról!

Állásajánlatok - legnépszerűbb városok