Senior Director Clinical Development (w/m/d)

Ansprechpartner
Dilsâd Babayigit
+49 (0)89 7263 210 – 00
babayigit@ageneo.de
Branche
Biotechnologie
Berufsfeld
R&D
Region
Bayern

DAS UNTERNEHMEN

For a growing and exciting biopharma company focussing on biosimilars, we are currenty looking for a Senior Director Clinical Development (w/m/d). As such, you will be involved in the further clinical strategy and development of the company and will be responsible for the clinical portfolio. You will lead and manage the clinical team and will be the interface for other stakeholders internally and externally. 

IHRE AUFGABEN

  • You lead and supervise the clinical development department
  • You also lead clinical operations and trial management
  • You are responsible for the clinical development strategy and execution for the complete portfolio of the company
  • You prepare, develop, and review relevant documents (IND, aBLA, CTA, study documents, CRFs...)
  • You select and work closely with CROs and other external consultants 
  • You prepare and host health authority inspections
  • You prepare and set-up clinical strategies and execute their operations

IHR PROFIL

  • Extensive professional experience in clinical trial design, execution, and interpretation of results for international registrations
  • Thorough understanding of all phases of biopharma (ideally biosimilar!) drug development in compliance with FDA and EMA regulations
  • Therapeutic area experience in immunology or/and opthalmology would be ideal
  • Experience in collaborating with and instruction of CROs
  • Profound knowledge of innovative trial design methods
  • Experience in negotiation and interaction with international health authorities
  • Experience with relevant regulations
  • Leadership experience and excellent communication skills

BENEFITS

  • High-impact function 
  • Ambitious team and very productive atmosphere
  • Additional social benefits