Descripción de la oferta
International Pharmaceutical Company Clinical Development Director About Our Client International Pharmaceutical Company based in Barcelona, Spain. Job Description As Clinical Development Director, you will hold ultimate responsibility for the design, execution, and analysis of clinical trials (Phase I-IV), ensuring compliance with the 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 the 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, a 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. The Successful Applicant 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. 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 cross-functional approach. Good leadership and communication skills. What's on Offer Great professional opportunity. #J-18808-Ljbffr