Clinical Strategy Manager

Clinical Strategy Manager

Location – Vienna, Austria

Company –

A medium sized pharmaceutical company with 3 commercialised products and much more coming in the pipeline, the company has focused their efforts on providing products to address previously unmet medical needs. Every member of the team is driven by the knowledge their efforts are providing highly needed solutions for the patients.

The Role –

In this role, you would be responsible for the Clinical side of the study (Phase III/IV) and providing regulatory input for the interactions with the FDA and EMA

Summary of Key Responsibilities

• Develop clinical study documents, and be responsible for individual clinical study tasks
• Medical writing for clinical and regulatory documents focused on FDA and EMA submission
• Perform analysis and interpretation of clinical study trials data
• Organize advisory boards and study committees (Scientific Advisory Boards, DSMBs, Endpoint Adjudication Committees, etc.)
• Conduct and summarise literature searches and competitive landscape reviews to support decisions on study designs, endpoints, assays, etc.

Required Experience

• Education
  • Scientific Background (PhD,Masters, or MD )
• Specific Background
  • Experienced in Clinical Development
  • Strong background with Medical writing
  • Regulatory input with EMA and FDA
  • Experienced working in Phase III/IV
  • Knowledge on writing manuscripts

Compensation:

• Midpoint of €70,000 salary (flexible based on experience)
• Annual Bonus
• Multiple benefits (meal vouchers, company events, kindergarten
• Flexible working for home base/office based – 5 days a month in office on average

Interested in finding out more? Then please send a CV or just drop me a message directly!