Director, Clinical Operations
|Mar 24, 2021
|Focus / Industry:
Toronto, Ontario, Canada
Boston, Massachusetts, USA
Seattle, Washington, USA
Cybin has an exciting opportunity for a Director, Clinical Operations to join the growing team!
A leading biotechnology company, Cybin is focused on and dedicated to progressing psychedelic therapeutics by utilizing proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for psychiatric disorders. To learn more about Cybin, visit https://www.cybin.com.
Reporting directly to the SVP, Quality Assurance & Regulatory Affairs, the Director of Clinical Operations is responsible for leadership of all clinical development deliverables to support Cybin’s program to advance psychedelic therapeutics. The role involves integrating strategy, design, feasibility, and operational planning to produce business-focused clinical drug development programs that align with the company strategy. This position can work remotely or out of our Toronto, Boston or Seattle offices.
- Responsible for the operational strategy and overall execution of Phase 1, Phase 2, and Phase 3 clinical programs with psychedelic therapeutics, which includes scope, quality, budget, time, resources, and risk
- Work closely with functional areas and CROs to facilitate the execution of clinical trials and programs
- Provide clinical/scientific input during the development, execution, and completion of clinical trials within study timelines
- Lead preparation of clinical portions of all relevant regulatory filings (IND/CTA, NDA/MAA) and review sections from other functional areas
- Identify and interact with KOLs and academic organizations to assure incorporation of latest clinical thinking and guidelines into clinical development plans
- Serve as clinical resource for issues raised by internal and external collaborators, investigators, consultants and business development and investor contacts
- Provide clinical expertise and strategic input on new product concepts, long-range strategic plans, and licensing opportunities
- Develop and manage the global clinical operations budget with a focus cost effectiveness, efficiency, and quality
- Organize & conduct internal leadership meetings to share clinical trial strategies, risk mitigation tactics and post study lessons and assessments
Knowledge, Skills & Technical Abilities
- B.A./B.S. in Science, Pharm D, PhD in psychology, or Master’s Degree preferred
- Substantial pharmaceutical development experience in clinical research, neuroscience, or adjacent therapeutic areas
- 10+ years of experience in clinical research in the pharmaceutical industry, including 5+ years clinical study/program management; program management experience required
- Experience in preparation of regulatory submissions to US, Canada, and European regulatory agencies
- Excellent written and verbal communication skills and proven ability to work in an international collaborative environment
- Ability to effectively lead cross functional teams and successfully leverage internal and external partnerships
- Excellent organizational and time management skills, ability to lead and manage multiple complex projects
- Strong working knowledge and applicable understand of CFR and ICH GCP guidelines
- Experience in setup, execution, and operational management of domestic and international Phase 1, 2, and 3 clinical trials
- Must be able to review clinical study tables and listings to ensure clinical data integrity
- Ability to travel to clinical study sites, labs, etc. as needed
If you are passionate about pursing this position, please submit your resume and cover letter as one attachment to firstname.lastname@example.org no later than April 5th, 2021.
Cybin Inc. is an Equal Opportunity Employer. All qualified applicants will be considered for employment without regard to ethnicity, color, national origin, age, religion, sexual orientation, gender identity or expression, family or parental status, veteran status, neurodiversity status, disability status or any other basis protected by applicable law. We are proud to provide employment accommodation during the recruitment process. Should you require an accommodation, please contact us at HR@Cybin.com and we will work with you to meet your accessibility needs. We welcome applications from all qualified candidates. We thank all those who apply. However, only those selected for an interview will be contacted.