Assistant director Jobs in Grünwald
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Assistant director • grunwald
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Director / Sr Director / Executive Director- Clinical Development (Dermatology)
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subrosa health groupMunich , DEBeliebte Suchanfragen
Director / Sr Director / Executive Director- Clinical Development (Dermatology)
Glenmark PharmaceuticalsMunich , DEPlease Note : Incumbent can be based anywhere in Europe or US
The Clinical Sciences / Clinical Development Director for dermatology shall be responsible to provide a high level of clinical expertise in the area of Dermatology from the pre-registration stage to the commercialization of the innovative products to achieve Glenmark’s objective in various markets. The person shall be responsible to provide strategic & tactical clinical leadership to enable successful evaluation and planning of clinical development program, protocol preparation, trial execution from a medical perspective and regulatory interactions for registration clinical trials and life cycle management of innovative, speciality dermatology products across various markets. Additionally, the person shall review scientific data and perform due diligence for in-licensing of potential assets. The person shall act as the conduit between multiple internal as well as external stakeholders throughout the development and life cycle of the products in various markets. The person should be a trained dermatologist with experience working in clinical sciences / clinical development for registration assets and having experience working with various regulators including EU / USFDA, etc.
Job Responsibility :
- Critical evaluation of clinical data of the investigational products, similar drugs from clinical sciences perspective to build a foundation for clinical development strategies for registrational purposes.
- Closely collaborates with various teams (including Clinical Development team members, Project Management , Clinical Operations, Pharmacovigilance, Regulatory, Global Medical Affairs, Intellectual Property) for clinical development planning, protocol development & finalization, execution support, regulatory presentations and approvals interactions, etc.
- Medical monitoring and supervision of the clinical dermatology studies
- Develops and maintains collaborative partnerships with dermatology stakeholders , key external experts, and allied health professionals ensuring scientific understanding and advocacy around products and therapeutic area
- Global medical affairs team to provide medical / scientific expertise on due diligence of new product licensing and acquisition opportunities for late-stage compounds and marketed products.
- Plans publication / presentation of data in international conferences, scientific symposia’s, etc and / or journals in line with the clinical data generated
- Ensures that all activities are carried out in compliance with Glenmark standards, standard operating procedures and external regulations
Knowledge and Experience :