Clinical Trials Director
4 days ago
Essential Pharma is seeking a highly skilled Clinical Trials Director to lead the overall management and oversight of clinical trials. As a key member of our team, you will be responsible for ensuring the successful planning and execution of clinical studies.
Key Responsibilities:
- Study Planning and Execution: Develop detailed project plans, including timelines, budgets, and resource allocation.
- Regulatory Compliance: Ensure all trials are conducted in compliance with GCP, FDA regulations, and other applicable regulatory requirements.
- Regulatory Document Management: Manage the preparation and submission of regulatory documents, including INDs, IRBs, and ECs.
- Site, Data, and Vendor Management: Oversee the management of sites, data, and vendors.
- Budget, Resource, and Risk Management: Manage budgets, resources, and risks associated with clinical trials.
About Essential Pharma:
Essential Pharma is an international specialty pharmaceutical company dedicated to maintaining access to clinically differentiated, niche medicines in small patient populations. Our high-impact portfolio includes over 300 medicines covering ten therapeutic areas, with a focus on the central nervous system (CNS), gastroenterology, ophthalmology, and rare diseases.
Our Team:
Our UK Operations team is comprised of 60 people, based out of our Egham, Surrey office. We offer a dynamic and supportive work environment, with a focus on collaboration and innovation.
Requirements:
- Education: Degree or equivalent in life sciences, medical science, or nursing.
- Experience: Clinical trial management experience gained in a Clinical Trial Manager role with a proven track record of managing clinical studies.
- Regulatory Knowledge: Global regulatory knowledge (including the US), experience of biologics, oncology, and pediatrics would be highly desirable.
- Skills: Strong knowledge of GCP, ICH guidelines, and regulatory requirements.
What We Offer:
- Agile Working: We offer flexibility and trust from day one, with the option to work from home or in our office.
- Benefits: ~£150 towards your home office, healthcare insurance, pension, life insurance, enhanced family leave, enhanced sick pay, annual leave, discretionary annual performance bonus, and recognition program.
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