Senior Clinical Operations Manager (gn)

  • Formycon AG
  • Senior, very experienced
  • Medicine, Pharmacy, Laboratory
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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 200 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 Clinical Operations 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

  • Plan and prepare department/study related documents/activities and operational oversight (e.g. CROs) under minimal supervision and coordination with involved SME departments and external partners
  • Lead assigned activities that ensure quality, consistency and integration of study deliverables / data to agreed time, cost and quality objectives
  • Support review and revision of study related documentation (e.g. clinical trial protocol, patient information, clinical study report) and other functional documents (e.g. monitoring plan)
  • Represent Clinical Operations in internal and external project team meetings
  • Lead CRO interaction and oversight, serve as primary contact person and continuously assess CRO performance
  • Identify and resolve any clinical trial related issues and risks
  • Participate in review activities (e.g. blinded data review meetings) and co-monitoring visits / on-site audits
  • Ensure compliance to time schedules and study budget as well as study-specific administration and archiving
  • Harmonize internal and external clinical study activities to assure compliance to GCP, relevant guidelines and local laws
  • Support selection process of study vendors and trial sites
  • Support non-study related activities and department processes and procedures
  • Participate in audits and regulatory meetings
  • Establish and coordinate interactions/relationships with internal and external partners (CROs, KOLs, labs, specialist service providers, consultants, license partners)
  • Coordinate packaging and labeling activities at CMOs as well as material shipping to study sites.
  • Create and monitor the Drug Supply Plan and Forecast for the seamless supply of international clinical trials (Phase I-IV)
  • Management of the supply chain for study medication
  • Monitor the cold chain and handle deviations while ensuring compliance with operational quality standards in cooperation with QA
  • Prepare SOPs and work instructions
  • Participate and take an active role in Investigator Meetings
  • Professionally guide and supervise your colleagues
  • May take over responsibility/accountability for global clinical programs (Global Clinical Program Manager)

Your qualifications

  • 6-10 years professional experience with Phase I-IV clinical trials
  • Very thorough knowledge of relevant legislation and international guidelines (e.g. ICH-GCP) for the performance of clinical research projects
  • Experience in development of biological drugs / biosimilars preferable
  • Advanced computer skills (MS-Office)
  • Fluent in written and spoken English, German knowledge preferable
  • Very strong presentation, communication and networking skills

We offer

  • Flexible working time
  • Hybrid 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 46 204.