The Director Clinical Research and Development should be a highly qualified and motivated individual who will take a leadership role in the development of our compounds in autoimmune and acute inflammatory diseases. He/she should have extensive clinical and scientific experience, a strong network in the medical community, and a successful track record in leading clinical programs. He/she reports to the Chief Medical Officer. The position is located in Jena, Germany or Munich, Germany.
Create and execute global clinical development plans consistent with the Company’s strategic vision and mission
Support regulatory interactions, including the preparation of regulatory documents and presenting at meetings with regulatory agencies
Ensure the optimal planning, implementation and interpretation of clinical studies
Specifically analyzing potential issues and risks that affect the project, particular those that affect the quality and integrity of the data and the safety of the drugs
Maintain and build productive relationships with investigators, thought leaders and centers of excellence across the scientific community, as well as with colleagues across the organization
Interact with sites to support study awareness, patient recruitment, and quality of study conduct
Communicate appropriate program issues and results to key internal and external stakeholders
Develop a strong knowledge base of the relevant therapeutic area and drug development issues and become a company expert for the respective treatment to ensure that study concepts, protocol summaries and final protocols related to the relevant development plans are high quality, state of the art and aligned with related Clinical Development Plans and Target Product Profiles
Comply with current local and international regulations, laws, scientific and regulatory guidance, Good Clinical Practice, and internal policies and procedures
M.D. or Ph.D.
Minimum of 5 years’ experience in the biotech, pharma or CRO industry
Knowledge of all aspects of the clinical drug development process, including experience in successfully creating and implementing development plans for drugs
Experience with monoclonal antibodies is preferred
Experience in the writing and/or participation in the preparation of submission documents
Ability to engage in an open, constructive and continuous dialogue with the Company’s stakeholders based on equality and mutual respect; transparency is critical and a key element to success
Effective communication and presentation skill
Fluent in written and verbal business English
Highly motivated, self-driven and dependable
Ability to travel (domestic and international travel is required)
We offer a multilayered and varying field of activity. You will be able to introduce your own ideas and concepts in a fast growing organization with a young and highly motivated team. We look forward to receiving your application by e-mail.