Head of Clinical Development (gn)

  • Medicine, Pharmacy, Laboratory
  • Research, development, teaching
  • Fulltime
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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 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.
 
We are looking for a Head of Clinical Development (gn) in full-time to strengthen our team in Martinsried near Munich to begin work as soon as possible.

Your responsibilities

The position holder leads the clinical R&D department, is responsible for strategy, design & conduct of all clinical drug programs and supports and ensures fast and efficient development and registration of the assigned portfolio in compliance with applicable laws guidelines and best practices.
This includes the following tasks:
  • Lead the clinical development department
  • Lead operations of clinical trials
  • Preparation of study relevant documents for submissions of Biosimilar registrations
  • Lead CRO selection process
  • Close cooperation with CROs
  • Close cooperation with consultants e.g. medical writing, Biostatistics
  • Budget responsibility for CRO contracts and all consultant activities within clinical development
  • Develop & review health authority documents (briefing documents, IND, aBLA, BLA, CTD and equivalents) and study-related documents such as IB's, CRFs, Protocol, CSRs etc.
  • Prepare and host health authorities inspection
  • Lead due diligence activities for licensing of new biosimilar candidates with focus on clinical development
  • Prepare clinical strategies for new development candidates
  • Direct staff to ensure operation´s efficiency and to ensure that international health authority standards and project goals/timelines are achieved
  • Interact closely with regulatory department, program management and quality department
Impact on organization:
  • Staff responsibility: line management of small to mid- size team
  • Financial responsibility: responsibility for assigned clinical program budgets
  • Key to ensuring fast and efficient registration of biosimilars through effective cross-departmental coordination

Your qualifications

  • Thorough understanding of all phases of global biopharmaceutical drug development in line with EMA and FDA drug development regulations
  • Minimum 15 years of relevant experience in all elements of clinical trial design, execution and interpretation of results from phase I to phase IV studies for international registrations
  • Demonstrated experience with Biosimilars preferred
  • Therapeutic area expertise in immune diseases and ophthalmology as a plus
  • Strengths in instructing CRO to perform according to expectations
  • Demonstrated success in working with KOLs and PIs
  • Thorough knowledge of innovative trial design methods (e.g. statistical modeling, biomarkers, surrogate parameters)
  • Experience in negotiations and interaction with health authorities including EMA and FDA; experience PMDA and other authorities of advantage
  • Experienced in medical writing e.g. reviewing & editing briefing books, protocols, INDs and CSRs
  • Expertise in GcP and associated SOP system
  • Experience in people development, minimum 5 years leading clinical development teams
  • Excellent communicator/ability to present, write effective reports, respond to questions from senior management, regulators, KOLs and customers
  • German work permit is mandatory

We offer

  • Flexible working time
  • mobile working
  • 30 days paid vacation
  • Formycon pension
  • Group accident insurance
  • Formycon card
  • Continuing education offers
  • Team spirit and 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.