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    Head of Pharmacology and Toxicology (m/f/d)

    from: 04.10.2022
    medac is a dynamic company that has been growing continuously for over fifty years. More than 2,000 employees work on the further development of medical products and medical devices for the diagnosis and treatment of oncological, urological and autoimmune diseases. We are one of the leading pharmaceutical companies, in particular in the field of niche products.
    • Disciplinary lead of the nonclinical department
    • Responsible for the scientific output and management of the Department in accordance with the strategic objectives of the company
    • Provides leadership and nonclinical expertise for our entire product portfolio and development pipeline
    • Responsible for conception and management of nonclinical drug development programs as well as life-cycle activities according to appropriate governmental and regulatory requirements (like GLP/ICH, OECD, EMA, FDA) and company's SOPs and development strategy
    • Responsible for nonclinical excellence and operational support in preparation of relevant nonclinical regulatory documents in the course of nonclinical, quality and clinical development of investigational new drugs as well as in the context of generic, bibliographic or full dossier submissions for marketing authorization
    • Responsible for creation and regular updates of existing nonclinical documentations such as nonclinical parts of development plans, briefing books for scientific advice, target product profiles, investigational medicinal product dossiers, investigator´s brochures, developmental safety update reports, periodic safety update reports, orphan drug applications, paediatric investigational plans, and CTD modules 2.4, 2.6 and 4
    • Supports pre-clinical evaluations and due diligences (gap-analysis) of new product opportunities
    • Works towards a learning organization and ensures expanding the department’s expertise according to the needs of innovative product development candidates, provides training measures and external consultancy activities
    • Fosters efficient cross-functional cooperation and quick decision making in his/her department
    • University degree in medicine or life science
    • 10 years + nonclinical development experience within the Pharmaceutical Industry, preferably in the indications oncology, haematology and autoimmune diseases.
    • Experience on small molecule, biologicals (ATMPs), therapeutic cell product development, as well as biosimilar approaches
    • General knowledge in the field of nonclinical in vitro / in vivo pharmacodynamic-, pharmacokinetic- and toxicology testing
    • Demonstrated track record in successful product developments (regional and global)
    • Leadership quality
    • Capability of developing strategies and executing at the same time (strategic thinker)
    • High communication and cooperation ability
    • Ability to work in teams
    • Fluency in English and German
    • Your work-life balance is important to us. We offer flexible working conditions with the option of working up to 60% of your hours remotely, 30 annual vacation days and an excellent cafeteria
    • Attractive salaries and success-based bonuses for all medac employees
    • Individual training opportunities: Our medac academy offers a wide range of programmes including leadership training, coaching essentials and language classes
    • A funded pension scheme and other social benefits
    • We care for our employees beyond the workplace and provide advice on caring for elderly relatives as well as offering counselling and childcare
    • We promote sports and activities to improve our employees’ health
    If you are looking for a new career challenge and a future-oriented role, then we are looking forward to receiving your application including your earliest possible starting date and salary expectations. For your convenience, please feel free to use our online application form on medac.de
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