Lead Clinical Research Director
il y a 5 jours
A cutting-edge biopharmaceutical company focused on developing innovative treatments for rare and life-threatening liver diseases is seeking a skilled Lead Clinical Research Director. This opportunity allows you to contribute significantly to groundbreaking medical advancements and improve patient outcomes globally.
The Organization:
With over two decades of expertise in liver disease research, this organization has established a robust R&D portfolio addressing unmet medical needs. Current areas of focus include Acute-on-Chronic Liver Failure (ACLF), cholangiocarcinoma (CCA), and urea cycle disorders (UCD), among others. Its global presence spans offices in France, Switzerland, and the United States, with a strong commitment to scientific excellence and patient-centered innovation.
Job Overview:
Reporting to the Senior Vice President of Clinical Strategy, the Lead Clinical Research Director will oversee the clinical development of assigned assets. The position involves managing all aspects of clinical trials, from strategy development to data analysis, regulatory reporting, and publication.
Main Responsibilities:
- Develop comprehensive clinical study plans aligned with overall program strategy.
- Lead the creation of clinical protocols, amendments, and study reports.
- Contribute to regulatory submissions, including INDs, DSURs, and clinical sections of BLAs/CTDs.
- Oversee the execution of clinical trials, ensuring compliance with Good Clinical Practices (GCP).
- Collaborate with cross-functional teams to design statistical analysis plans and operational strategies.
- Engage with external stakeholders, including regulatory authorities and Key Opinion Leaders (KOLs).
- Monitor and analyze clinical data to inform decision-making and scientific publications.
Candidate Profile:
- Educational Background: PhD (MD, PharmD, or equivalent).
- Experience: 7+ years in clinical development, research, or related fields in the biopharmaceutical or healthcare industry.
- Expertise: Strong understanding of liver diseases, clinical trial design, and regulatory frameworks.
- Leadership: Demonstrated ability to lead multidisciplinary teams and solve complex challenges.
- Skills: Strategic thinker with excellent communication and analytical skills.
- Language Proficiency: Fluency in English (B2+ level); French language skills are advantageous.
What's Offered:
- A pivotal role in a company driving innovation in rare and serious diseases.
- Opportunities to collaborate with a highly skilled and passionate team.
- A competitive compensation package of approximately $250,000 per annum, including benefits.
This position is ideal for a clinical research professional eager to make a meaningful impact in the biopharmaceutical sector.
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