Website Opiant Pharmaceuticals
Clinical Operations Director
This position is based in the United Kingdom
Opiant Pharmaceuticals, Inc., the company that developed NARCAN® Nasal Spray, is building a leading franchise of new medicines to combat addictions and overdose. We are a publicly traded company, listed on the NASDAQ exchange under the ticker symbol OPNT. At Opiant, we envision a world where addictions are recognized as diseases of the brain and treated like other chronic medical conditions. We are applying science and technology to address some of the most serious conditions affecting our communities, including opioid overdose and opioid use disorder; acute cannabinoid overdose; and alcohol use disorder. We aspire to be the leading life science company in this field of healthcare. For more information visit: www.opiant.com.
We are looking for a Clinical Operations Director to coordinate the clinical activities and ensure compliance to applicable regulatory guidelines and ICH GCP.
Your key responsibilities:
- Design, develop and oversee clinical operations across all development projects.
- Lead the clinical team setting the standards for clinical operations performance, building the culture of collaboration required for success and coaching and developing the team for future growth.
- Actively builds, coaches and develops the clinical team.
- Ensure clinical trial teams and clinical trial sites are properly trained and in compliance with protocols, ICH GCP, relevant SOPs and any relevant local regulations.
- Manage 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 program.
- Interact with investigators and thought leaders for protocol development, presentations and publications.
- Clinical review as required for product in-license opportunities as part of due diligence activities.
- Build and maintain effective relationships with external stakeholders.
What you’ll bring to the role:
- Educated to degree level or equivalent.
- Minimum of 15 years experience in clinical development and 5+ years management experience.
- Demonstrate experience in leading and delivering the clinical development of projects in accordance with US and EU guidance.
- Demonstrate experience in designing and developing clinical trial programs and protocols.
- 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.
Opiant offers attractive and competitive benefits, exciting development opportunities and a great atmosphere. You will be part of an enthusiastic, dedicated and highly motivated team.
Opiant Pharmaceuticals is an Equal Opportunity Employer and we take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
Commitment to Diversity & Inclusion:
Opiant embraces diversity, equal opportunity, and inclusion. We support employees who are in recovery from substance use disorders. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace where we work to the following ‘O-P-I-A-N-T’ standards: open-minded, professional, innovative, accountable, nimble and trustworthy.