Senior Medical Director Clinical Development
vor 3 Wochen
Proclinical is seeking a dedicated and experienced Senior Medical Director for Clinical Development. The successful candidate will be responsible for the medical monitoring of assigned clinical development programs and the strategy and implementation of one or more clinical development programs. This role involves working closely with external experts and academic collaborators, contributing to signal detection, and ensuring adherence to Good Clinical Practice and all applicable local and international regulations.
Responsibilities:
Develop clinical plans, manage development risks, monitor progress, and implement contingencies as required.Collaborate with Preclinical to ensure that preclinical development programs and data support the onset of clinical development activities.Develop clinical study protocols and other study-specific regulatory documents.Contribute to the preparation, development, review, and finalisation of regulatory documents related to key interactions with regulatory authorities.Participate in business development initiatives for new programs as needed.Contribute to vendor selection in collaboration with Clinical Operations.Represent the company at key internal and external meetings as requested.Participate in the selection process of new candidates for the company across functions as needed.Key Skills and Requirements:Experience working in clinical development/medical monitoring positions for Pharma Companies and/or CROs, with a particular focus on rare disorders.Background in neurosciences and/or neurometabolic diseases and/or immunology and/or genetic medicine is desirable.Understanding of regulatory environment, GCP/ICH and GMP, experience dealing with regulatory agencies and MAA/BLA regulatory filings in the EU and/or US.Robust understanding of all aspects of clinical development.Experience working with matrix teams.Excellent organisational skills; ability to prioritise activities depending on business imperative and to contribute to several projects in parallel.Outstanding presentation skills (Excel, PowerPoint).Able to manage complex data and work in a pressurised environment.First-rate academic background, educated to degree level, (MD, General Medicine).Specialise in Neurology, Paediatrics, Immunology or Medical Genetics would be preferable. If you are having difficulty in applying or if you have any questions, please contact Kain Rix at Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies. Proclinical Staffing is an equal opportunity employer. #MedicalAffairs-
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