ppExperience: 3 to 5 years in similar roles. /p pWant to know more? /p pINSUD 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. /p pINSUD 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 RD 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. /p pReady to become a #Challenger? /p h3What are we looking for? /h3 pPlanning, 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. /p h3The challenge! /h3 ul liAssume 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: /li liDesign and manage the clinical trials according to plan and in compliance with applicable laws, regulations, and guidelines (ICH, EMA, FDA, and others).



/li liParticipate 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). /li liReview 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. /li liCoordinate internal Chemo activities and procedures related with the conduct of the clinical trials (e.g. investigational medication shipment, etc.). /li liCollaborate in the interaction with Health Authorities: Scientific Advices and Deficiency Letters. /li liCollaborate 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. /li liParticipate on the maintenance of GCP system through elaboration and/or review of SOPs, etc. /li liContribute to the maintenance of GCP system through elaboration and/or review of SOPs, etc. /li liSpecific Knowledge: /li liExperience in integral Clinical Development, primarily in PK and BE studies: /li liCurrent 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.



/li liExperience in studies design and studies program development. /li liPreparation and review of study documentation. /li liImplementation of trials in global environment: Site selection and management (clinical / bioanalytical sites, monitoring activities). /li liProject management of multiple studies /li liExperience 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. /li /ul h3Experience (years/area): /h3 ul liMandatory: Degree in Medicine, Pharmacy or Life Science /li liDesired: Training/experience in Pharmacokinetics, bioequivalence studies and most of the relevant guidelines. /li liFluent in English required, communicative level in Spanish preferred, knowledge of other languages will be an asset. /li liAt least 3 years of experience in a similar position. /li /ul pFlexible start hours from Monday to Friday (full 40-hour workweek). /p ul liAttractive salary package. /li liCompany cafeteria (free of charge). /li liBenefits and Savings Club. /li liDevelopment plans, internal mobility policy. /li liAnd much more! /li /ul pCOMMITMENT TO EQUAL OPPORTUNITIES /p pThe 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. /p /p #J-18808-Ljbffr

📌 Clinical Development Leader (Azuqueca de Henares)
🏢 Chemo
📍 Azuqueca de Henares