Clinical Development Manager (gn)

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Formycon is a leading, independent developer of high-quality biopharmaceutical medicines, especially biosimilars.
With an experienced team comprised of more than 170 professionals, the company is able to span the entire value chain of biosimilar drug development, from market analysis and target definition by protein analytics, to the development of production processes, to clinical trials and the regulatory approval process.

Formycon is making a major contribution towards providing as many patients as possible with access to vital and affordable medicines. Based on its extensive experience in the development of biopharmaceutical drugs, the company is also working on the development of a COVID-19 fusion protein.

To support our team in Martinsried near Munich, we are looking for suitable candidates for this full-time and permanent position, to begin work as soon as possible.

Your responsibilities

  • Prepare tailored medical / clinical strategy for biosimilar candidates (e.g. PK / PD, most sensitive indication, primary endpoints, equivalence margin and justification)
  • Prepare relevant clinical parts of regulatory documents and coordination with involved SME, departments, external partners
  • Prepare clinical parts of briefing books, CTA / IND submission and answer clinical questions
  • Contribute to essential clinical documents and tasks including but not limited to protocol/amendment update, IB update, annual study report, data cleaning activities, trend analysis and TFL review
  • Analysis of clinical data and review of clinical study reports (CSR)
  • Ensure compliance to GCP, ICH and other ethical and company policy at all time
  • Support drug safety and/or pharmacologic evaluations
  • Review SAE’s and safety data, ensure all relevant parties are notified and the company is compliant
  • Present the medical /clinical strategy to internal and external stakeholders
  • Build relationships to key opinion leaders
  • Accountability for deadlines within area of expertise
  • Participate in audits and regulatory meetings
  • Adherence to and continuous improvement of internal quality standards and workflows
  • Independent planning and preparation of department/study related documents/activities and clinical strategies and coordination with involved SME departments, external partners

Your qualifications

  • MD or clinical pharmacologist (or equivalent)
  • 5-8 years of relevant work experience; other education and relevant work experience may be considered
  • Deep knowledge in the clinical development of biological drugs and biosimilars
  • Deep understanding of physiological processes and relevant medicinal literature
  • Experienced with interactions within cross-functional teams, with external consultants and regulatory authorities (e.g. Scientific Advice)
  • Skilled in the establishment and coordination of interactions/relationships with internal and external partners (CROs, labs, specialist service providers, consultants, license partners)
  • Fluent in written and spoken English, German knowledge preferable
  • Very strong presentation and communication skills
  • Strategic thinker
  • Excellent time management
  • Networking skills

We offer

  • Flexible working time
  • Mobile work
  • 30 days paid vacation
  • Formycon pension
  • Group accident insurance
  • Formycon card
  • Continuing education offers
  • Team spirit, great working atmosphere and much more!

Bring us your skills and energy, and shape your own career in a stimulating and open work environment. We are looking for highly motivated individuals who are ready to take on new challenges with enthusiasm and personal commitment. Working at Formycon means being part of a smart, innovative team with minimal hierarchy and opportunity to share your own ideas.

Have we sparked your interest? Then we look forward to receiving your application for employment through our online application portal. Please be sure to include all supporting documents, along with your earliest possible starting date and your salary expectations. We look forward to learning about you and the qualifications which you would bring to this position.

Our recruiting process is supported by the recruiter service by Constares GmbH. For initial questions, please contact Rebecca Schön:+49 89 1241 46204