Descripción de la oferta
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.
Flexible start hours from Monday to Friday (full 40-hour workweek).
Permanent contract.
Co-payment for voluntary health insurance.
Development plans, internal mobility policy.
⭐We will continue with a face-to-face/virtual interview based on availability and as agreed; there may be one or two interviews, and depending on the type of process, there may also be some kind of test.
➡️Follow us on social media like LinkedIn/Instagram and stay tuned for any offers we post. The InsudPharma group is aware that business management must align with the needs and demands of society, and therefore assumes the commitment to equal opportunities and treatment between men and women, as established in current regulations - Organic Law 3/2007, and we do not discriminate against anyone based on ethnicity, religion, age, sex, nationality, marital status, affective or sexual orientation, gender identity or expression, disability, or any other personal or social circumstance.
