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