Associate Director of Clinical Operations
Salary: $200,000- $225,000
A dynamic and rapidly expanding pharmaceutical company at the forefront of groundbreaking medical advancements is seeking a highly qualified and motivated individual to join their team as an Associate Director of Clinical Operations. The company has quickly risen to prominence as a leader in the pharmaceutical industry, driven by its unwavering commitment to innovation, research excellence, and patient-centric solutions. As they continue to grow nationwide, they are dedicated to advancing healthcare and improving the lives of patients worldwide.
Position Overview:
This company is seeking a highly qualified and motivated individual to join our team as an Associate Director of Clinical Operations. As a rapidly growing pharmaceutical company, they are dedicated to advancing healthcare and improving the lives of patients worldwide. The Associate Director of Clinical will play a pivotal role in driving their clinical development programs forward and ensuring the success of our innovative therapies. They will also be seen driving the clinical development programs forward and ensuring the success of their innovative therapies.
Responsibilities:
- Provide leadership and strategic direction for the planning, execution, and management of clinical trials across various phases, ensuring adherence to timelines, budgets, and quality standards.
- Collaborate cross-functionally with internal teams including Research & Development, Regulatory Affairs, Medical Affairs, and Commercial to drive alignment and achieve project goals.
- Oversee the selection and management of Contract Research Organizations (CROs) and other external partners involved in clinical trial conduct.
- Lead the development of clinical trial protocols, informed consent forms, case report forms, and other essential study documents.
- Monitor and analyze clinical trial data, identify trends, and provide insights to guide decision-making and optimize trial designs.
- Ensure compliance with all relevant regulatory guidelines, ethical considerations, and industry best practices throughout the clinical development process.
- Contribute to the development of clinical sections of regulatory submissions, including INDs, NDAs, and other relevant documents.
- Manage and mentor a team of clinical professionals, fostering their growth and development.
An ideal candidate will have the following qualification...
- Advanced degree in a relevant scientific field (PhD, MD, PharmD, or equivalent).
- 5+ years Clinical Trial Management experience, in an industry setting
- Proven track record of successful management and oversight of clinical trials, including experience with multiple phases of development.
- Strong understanding of GCP, ICH guidelines, and other relevant regulatory requirements.
- Excellent leadership and communication skills, with the ability to collaborate effectively across cross-functional teams and external partners.
- Experience with regulatory submissions and interactions with health authorities is preferred.
