Medical Director at HAL Allergy
HAL Allergy is looking for a Medical Director. This person serves as the internal and external medical expert of HAL Allergy. The Medical Director is engaged in defining the strategy, development and implementation of innovative clinical programs and the collaboration with strategic business partners. He/she provides overall medical (clinical and non-clinical) vision for HAL Allergy and guidance to ensure affordable, high-quality deliverables.
HAL Allergy is a modern company with high quality pharmaceutical GMP manufacturing and research facilities located in the Leiden Bio Science Park. With offices in seven European countries, we are one of the top European players in the field of allergy diagnostic and treatment. Since 1959 we have gained experience in developing, producing and selling allergy therapies for the treatment and prevention of allergic diseases. These immunotherapies are used primarily against common allergies such as hay fever, house dust mite allergy and allergic reactions towards wasp or bee stings. Beside the development and production of allergy vaccines, HAL Allergy started a new business in 2012. This new Contract Manufacturing Organization (CMO), named HALIX, is engaged in the production of biotechnological products for preclinical and clinical studies. HAL Allergy Group is a mid sized company with headquarters in Leiden. We employ around 300 highly specialized people acorss various functions. The departments at our headquarters include development, production, quality assurance and control, clinical and registration. Our staff work closely together with leading research institutes. At our locations in Germany, Poland, Austria, Spain and Italy we mainly focus on service and sales activities.
Serve as the medical expert within and outside the company and assist the management in achieving the company goals by providing fundamental input in defining the optimal way to develop and market immunotherapy. Provide leadership to the overall clinical vision and provides clinical direction to the entire HAL Allergy group. Candidate will be responsible for further developing the medical department of our organization.
Provide leadership in establishing and executing the clinical development strategy for the HAL Allergy product portfolio and provide leadership to the program of non-interventional and post-marketing studies.
Disseminate the clinical development strategy to important stakeholders internally (e.g., Supervisory Board, Scientific Advisory Board, BoD, R&D, Regulatory Affairs, Marketing & Sales.) and externally (e.g., regulatory bodies, CRO, and investigators).
Serve as internal and external medical expert at HAL Allergy, including serving as a key medical speaker on marketed products and products in development as well as providing medical and scientific input and support for presentations at international/national and regional meetings. Lead discussions with and influence academic and clinical opinion leaders, prescribers, and regulatory bodies. Define publication strategies and develop medical positioning for the Company's products. Manage the marketing product publications program together with the Marketing & Sales and Corporate Communication; review content of journal articles and other communications materials.
- Experience in the allergy/immunotherapy field is a distinct advantage.
- A proven record of direct experience working with clinical trials as an Investigator, Sub-Investigator, or Sponsor is desirable.
- Working knowledge of general medicine and drug therapy, including pharmacology, toxicology, pharmacotherapy, clinical trial methodology and an in depth knowledge and understanding of scientific principles for controlled trials, is essential.
- Working knowledge of clinical trial guidelines (ICH/GCP, EU CTD, international regulations), pharmacovigilance guidelines and regulatory guidelines for FDA submission (preferred).
- Experience interacting with regulatory agencies.
Personal and Professional skills:
- Strong people management skills.
- Ability to create and maintain team spirit
- Leadership: ability to change the mind-set of employees in a growing organisation and competitive business environment.
- Willing to take unpopular measures when necessary to reach goals.
- Strong communicator and ability to build bridges between groups and organizations.
- Good command of writing and speaking in (fluent) Dutch, English.
- Pro-active and solutions oriented.
- Ability to work under time pressure.
- Self-starter, hands-on, builder.
- Mentoring skills.
- Excellent command of both Dutch and English, in reading, writing and orally..
No unsolicited assistance from recruiters is absolutely not accepted for this employment.