Clinical Development Manager / Head Clinical Strategy (Biosimilars)
Gdańsk

Boost your career with us

Polpharma Biologics is a state-of-the-art biological R&D and manufacturing facility, one of the most modern in Europe. We have a fantastic, international team of experienced experts and dynamic young scientists with common goals and values. Biotechnology is our passion.

Together we develop medicines, offering a new hope to patients suffering from serious diseases. We create a passionate and friendly workplace environment. Join us!

Your role

The (Senior) Clinical Development Manager / Head Clinical Strategy (HCS) supports the clinical development programs for the investigational drug candidates of Polpharma Biologics. The HCS will provide strategic and medical input on the clinical development program for biosimilar programs. The HCS may also oversee one or more clinical development programs from planning, execution and dossier compilation of development programs at Polpharma Biologics.

The (Senior) Clinical Development Manager / Head Clinical Strategy (HCS) will report to Head Clinical Research and Development.

Your responsibilities

  • Contribution to clinical development strategies, including phase 1 and phase 3 study design
  • Open, effective, and proactive communication of the clinical development activities in close collaboration with other clinical development functions, clinical operations and other functions in drug development
  • Must have an excellent understanding of the drug development process and respective regulatory requirements
  • Strong experience in clinical strategies for Biosimilar development
  • Must be willing to travel to Polpharma Biologics offices in Poland, business partners, national and international (medical or industry relevant) congresses, conferences and symposia
  • May attend and present at scientific advice meetings at international HAs (e.g. EMA, FDA)
  • May interact with KoL, clinical advisory boards and DSMBs (Data Safety Monitoring Boards)
  • Must have strong work ethics and be able to work independently and productively
  • Provide clinical strategy also for clinical trials, e.g. for protocol development
  • May serve as clinical lead for clinical development programs, or support Clinical Program Head (CPH) in the planning and implementation of clinical development strategies
  • Represent clinical development in global program teams for assigned program(s)
  • May set up and lead Medical Advisory Boards
  • Interact with KOLs globally
  • Provide medical expertise on company portfolio for Biosimilars and innovative Biologics
  • Interact with Medical Experts / Medical Monitors from CROs
  • Present at Investigator Meetings for assigned clinical programs
  • Support clinical trial teams (CTLs) with Medical and Safety Expertise
  • Support company / CRO SOPs and develop internal SOPs as needed

If you have

  • PhD or doctorate degree (MD)
  • Should have a minimum of 10 years of clinical research and / or medical affairs experience
  • Work in Biosimilar development
  • Excellent working knowledge of ICH GCP guidelines, EMA, and other relevant regulations
  • Possess strong and influential leadership skills with proven ability to lead internal and external team members at all levels
  • Fluency in English, Polish is an advantage

We offer

  • International work environment
  • Attractive salary
  • Cutting-edge technology equipment
  • Conferences and trainings around the world
  • Private healthcare
  • Relocation package
  • Company car
  • And much more…
Join our Team!

Why you should work with us

Contact us
[email protected]