Clinical Development Leader
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.
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. 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).
Monitoring etc.) 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.
Experience in global Clinical Development, primarily in PK and BE studies:
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.
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.
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.
Versátil start hours from Monday to Friday (full 40-hour workweek).
Permanent contract.
Co-