A new opportunity has arisen for a Clinical Operations Director at Opiant Pharmaceuticals a specialty pharmaceutical company focused on addiction and drug overdose.
We are looking for a Clinical Operations Director to coordinate the clinical activities and ensure compliance to applicable regulatory guidelines and ICH GCP. Opiant is developing a range of products including nasal and injectable technologies.
Key Roles & Responsibilities:
- Oversee day to day clinical operations across all development projects.
- Line manage a team of CRAs and CTAs, setting the standards for clinical operations performance and build the culture of collaboration required for success.
- Ensure clinical trial teams and clinical trial sites are properly trained and in compliance with the protocol, ICH GCP, relevant SOPs and any relevant local regulations.
- Monitor clinical trial milestones, ensuring accuracy and any required actions are being taken to mitigate risks and address issues.
- Review, approve and/or generate clinical project deliverables such as clinical study protocols, regulatory and ethics submission documents, monitoring plans and tools, data management plans, clinical study reports, etc.
- Planning resources and tasks to meet corporate goals for timely initiation and completion of clinical studies.
- Interact with investigators and thought-leaders for protocol development, presentations, and publications.
- Educated to degree level or equivalent.
- Minimum of 10 years of experience in clinical development.
- Demonstrates experience in leading the clinical development of projects in accordance with US and EU guidance.
- Extensive clinical development experience using outsourced service providers.
- Excellent interpersonal skills, negotiation skills, and facilitation skills.
- Demonstrates strong analytical and problem-solving skills.
- Excellent verbal and written communication and computer literacy skills.
- Ability to work well autonomously and within a multi-disciplinary virtual team environment.