Clinical Development Director

Barcelona Permanente Remoto / híbrido View Job Description
International Pharmaceutical Company is looking for a new Clinical Development Director.Ideally, the role is based in Barcelona but we are open to consider candidates working in full remote.

Added 24/01/2025

  • International Pharmaceutical Company
  • Clinical Development Director

¿Dónde vas a trabajar?

International Pharmaceutical Company based in Barcelona, Spain.

Descripción

As Clinical Development Director, you will hold ultimate responsibility for the design, execution, and analysis of clinical trials (Phase I-IV), ensuring compliance with Company's QMS, ICH/GCP EU & US standards, local regulations, and allocated budgets. Leading a multidisciplinary team, you will oversee all clinical research functions, including project management, safety, monitoring, regulatory, and biometry. This role is critical in driving clinical excellence and ensuring that Company's clinical programs align with strategic goals, supporting the organization's mission to bring innovative solutions to market.

The position will report to the Chief Scientific Officer, member of the Executive Committee of the Company.

  • Lead the design, execution, and analysis of Phase I-IV clinical trials, ensuring compliance with Company QMS, ICH/GCP, and local regulations.
  • Develop and oversee clinical development plans, including study protocols, safety oversight, and adherence to budgets and timelines.
  • Manage and optimize clinical operations, including resource allocation, vendor management, and monitoring activities.
  • Supervise and mentor a multidisciplinary clinical team, fostering professional growth and high performance.
  • Provide clinical support to corporate functions such as Regulatory, Pharmacovigilance, Legal, BD, and Quality.
  • Build and maintain relationships with investigators, research sites, and KOLs to enhance trial design and execution.
  • Drive publication strategies by preparing clinical findings for scientific journals and conferences.
  • Support regulatory submissions, respond to queries, and present at regulatory meetings.
  • Contribute to organizational strategy through participation in executive committees and provide regular updates to senior management on clinical progress, risks, and milestones identifying opportunities for optimization.

¿A quién buscamos (H/M/D)?

Education and experience

  • Pharm D, or BS preferably in a relevant biological or health science discipline.
  • Clinical Research and GCP training
  • Clinical Project Management training (plus)
  • Proven leadership in clinical development, including Phase I-IV clinical trials.
  • Clinical research and clinical development experience required (CRA) (>10 years)
  • Experience in study management working with all drug/ medical device development phases. It will be valuable experience in respiratory or neurological clinical studies.
  • Deep knowledge of GCP, EU/US regulations, and quality management systems.
  • At least 6 years in a People Management position

Abilities and Skills

  • Strong ability to manage cross-functional teams and build relationships with internal and external stakeholders.
  • Strategic mindset with a track record of contributing to organizational growth through clinical innovation.
  • Can do attitude and willingness to be hands on
  • Excellent command of English
  • Flexibility to adapt to changing conditions.
  • Ability to work in multidisciplinary teams and in a crossfunctional approach
  • Good Leadership and communication skills

¿Cuáles son tus beneficios?

Great professional opportunity.

Ver más ofertas de empleo
Andrea Sileo
Indicar número de referencia para la oferta
JN-012025-6647066

Resumen de empleo

Sector
Healthcare
Sub Sector
Operaciones Clínicas
Industria
Healthcare / Pharmaceutical
Localización
Barcelona
Tipo de Contracto
Permanent
Nombre del consultor
Andrea Sileo
Número de referencia
JN-012025-6647066
Modalidad de trabajo
Remoto / híbrido

En Michael Page creemos en la diversidad e inclusión. Defendemos la igualdad de oportunidades sin discriminar por género, raza, edad, religión ni orientación sexual o por cualquier otro aspecto que pudiera ser considerado excluyente.