Clinical Pharmacology Director

hace 5 días

Barcelona, Barcelona, España Icon Clinical Plc A tiempo completo

Job Summary:

As a Clinical Pharmacology Director at ICON plc, you will play a key role in advancing clinical research and drug development. Your expertise will be instrumental in designing and reviewing product development plans, collaborating with key opinion leaders and regulatory authorities, and guiding the development of clinical development programs and studies.

Key Responsibilities:

  • Design or review product target profiles and overall product development plans, focusing on early development path to clinical proof-of-concept.
  • Liaise with key opinion leaders and regulatory authorities to challenge and improve draft target product profiles and development plans.
  • Review medical and scientific literature, and review preclinical and clinical safety and efficacy data of novel compounds.
  • Design or review study outlines in the early clinical development plan, including ADME, PK, and PK/PD studies.
  • Review study results and study reports, and guide the development of manuscripts and regulatory submission documents.
  • Develop and present innovative early clinical development, PK, PD, and biomarkers strategies.
  • Collaborate with clients on the design of drug development programs.
  • Provide formal training to staff and direct a group responsible for clinical pharmacology, PK, and PD activities.
  • Participate in business development activities and the RFP process, building and maintaining a network in the biotech and pharma landscape.

Requirements:

  • Proven expertise in clinical pharmacology, PK, and PD.
  • Strong understanding of regulatory requirements and guidelines.
  • Excellent communication and collaboration skills.
  • Ability to work in a fast-paced environment and prioritize multiple tasks.

About ICON plc:

ICON plc is a world-leading healthcare intelligence and clinical research organization. We advance clinical research, providing outsourced services to pharmaceutical, biotechnology, medical device, and government and public health organizations. Our people are our greatest strength, and we are committed to accelerating the development of drugs and devices that save lives and improve quality of life.

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