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In short Position: Clinical Development Leader Location: Azuqueca de Henares. Experience: 3 to 5 years in similar roles. Want to know more? INSUD PHARMA operates across the entire pharmaceutical value chain, providing specialized knowledge and experience in scientific research, development, manufacturing, sales, and marketing of a wide range of active pharmaceutical ingredients (APIs), finished dosage forms (FDFs), and branded pharmaceutical products, adding value for human and animal health. INSUD PHARMA's activity is organized into three synergistic business areas: Industrial (Chemo), Branded (Exeltis), and Biotech (mAbxience), with over 9,000 professionals in more than 50 countries, 20 state-of-the-art facilities, 15 specialized R&D centers, 12 commercial offices, and over 35 pharmaceutical subsidiaries, serving 1,150 clients in 96 countries worldwide. INSUD PHARMA believes in innovation and sustainable development. Ready to become a #Challenger? What are we looking for? Planning, designing, organization, supervision of conduct and reporting of clinical trial contracted to Clinical Research Organizations (CRO) to enable studies execution within the planned timelines and in compliance with current GCP and other applicable requirements. The main focus is on pharmacokinetic (PK) and bioequivalence (BE) trials. Multicenter clinical trials and phase II and III trials may also be required with the necessary support. The challenge Assume overall responsibility for the plan, design, execution, reporting and evaluation of results of clinical trials as well as assure conduct of the trials in compliance with applicable requirements including but not limited to GCP. Specific responsibilities include: Design and manage the clinical trials according to plan and in compliance with applicable laws, regulations, and guidelines (ICH, EMA, FDA, and others). Participate in the selection of CROs and other external vendors and control the execution of all contracted activities and ensure that the activities are conducted in accordance with the requirements (cost, quality, and time). Review the necessary documentation before (e.g. Protocol, ICF, etc.), during (e.g. Monitoring etc.) and at the end (e.g. Study Report, etc.) of clinical trials. Coordinate internal Chemo activities and procedures related with the conduct of the clinical trials (e.g. investigational medication shipment, etc.). Collaborate in the interaction with Health Authorities: Scientific Advices and Deficiency Letters. Collaborate with other departments and experts (e.g. in Pharmaceutical Development, Regulatory, Pharmacovigilance, Project Management) to define strategies and plans for projects execution and execute clinical activities according to agreed plans. Participate on the maintenance of GCP system through elaboration and/or review of SOPs, etc. Contribute to the maintenance of GCP system through elaboration and/or review of SOPs, etc. ~ Specific Knowledge: Experience in global Clinical Development, primarily in PK and BE studies: Current knowledge of laws, regulations, and guidance (ICH, EMA, FDA, etc.) related to design and execution of clinical trials, primarily PK and BE studies as well as demonstrating bioequivalence in general. Experience in studies design and studies program development. Preparation and review of study documentation. Implementation of trials in global environment: Site selection and management (clinical / bioanalytical sites, monitoring activities). Project management of multiple studies Experience in development of generic drugs and related methodologies: evaluation of in vitro dissolution studies results, evaluation of PK/BE studies results and reports, assessment of suitability of bioanalytical methods, in vitro/in vivo correlations etc. Experience (years/area): Mandatory: Degree in Medicine, Pharmacy or Life Science Desired: Training/experience in Pharmacokinetics, bioequivalence studies and most of the relevant guidelines. Fluent in English required, communicative level in Spanish preferred, knowledge of other languages will be an asset. At least 3 years of experience in a similar position. Our Benefits Flexible start hours from Monday to Friday (full 40-hour workweek). Permanent contract. Attractive salary package.
