Global Brand Innovation Lead

Chemo; Madrid; Presencial; EUR 60.000 - 80.000; Jornada completa

Descripción de la vacante

A leading pharmaceutical company in Madrid is seeking a Clinical Development Leader to lead the planning and execution of clinical trials. Responsibilities include overseeing clinical research organizations and coordinating with various departments for project execution. Candidates should have experience in global clinical development, project management, and fluency in English, with Spanish as a preference. The position offers flexible working hours and a permanent contract.

Servicios

Co-payment for voluntary health insurance

Formación

• Practical understanding of PK and BE studies and related guidelines.
• Experience in development of generic drugs and related methodologies.

Responsabilidades

• Planning, designing, organizing, supervising conduct and reporting of clinical trials.
• Collaborate with departments to define strategies and plans for project execution.
• Experience in study design and program development.

Conocimientos

Experience in global Clinical Development

Fluent in English

Communicative level in Spanish

Project management of multiple studies

Descripción del empleo

Overview

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). The group has over 9,000 professionals in more than 50 countries, 20 facilities, 15 R&D centers, 12 commercial offices, and over 35 pharmaceutical subsidiaries, serving 1,150 clients in 96 countries worldwide. INSUD PHARMA emphasizes innovation and sustainable development.

Responsibilities

• Planning, designing, organizing, supervising conduct and reporting of clinical trials contracted to Clinical Research Organizations (CROs) to enable study execution within 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 to ensure they meet cost, quality, and time requirements.
• Collaborate with other departments and experts (e.g., Pharmaceutical Development, Regulatory, Pharmacovigilance, Project Management) to define strategies and plans for project execution and to conduct 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 and demonstrating bioequivalence in general.
• Experience in study design and study program development; implement trials in a global environment with 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 results, evaluation of PK/BE results and reports, assessment of bioanalytical methods, and in vitro/in vivo correlations.
• Training/experience in Pharmacokinetics, bioequivalence studies and relevant guidelines.
• Fluent in English; communicative level in Spanish preferred; knowledge of other languages is an asset.
• Flexible start hours from Monday to Friday (full 40-hour workweek).
• Permanent contract.
• Co-payment for voluntary health insurance.

Qualifications & Requirements

• Development plans and internal mobility policy knowledge is desirable.
• Experience in the development of generic drugs and related methodologies as described in Responsibilities.
• Practical understanding of PK and BE studies and related guidelines.
• Ability to work in a global environment and coordinate with CROs and external vendors.

Additional Information

• We will continue with a face-to-face or virtual interview based on availability; there may be one or two interviews, and depending on the process, there may be some form of test.
• Follow us on social media like LinkedIn and Instagram and stay tuned for offers; the InsudPharma group is committed to equal opportunities and non-discrimination as per applicable regulations.

We do not discriminate on ethnicity, religion, age, sex, nationality, marital status, affective or sexual orientation, gender identity or expression, disability, or any other personal or social circumstance.