* 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+ 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
* Company's Pension
* Group accident insurance
* Company's card
* Continuing education offers
* Team spirit, great working atmosphere and much more
