PROJECT MANAGER, CLINICAL OPERATIONS
EMPLOYMENT STATUS: Full-Time Permanent
LOCATION: Home-Based Remote (Eastern Standard Time Zone)
DEPARTMENT: Clinical Operations
POSITION SUMMARY:
The Project Manager will be responsible for the management of all operational aspects of Phase I-IV clinical trials and Investigator Initiated Trials (IIT) conducted by us. This role will offer supervision and oversight of all functional areas and third-party vendors aligned with trial conduct. The Project Manager will work with key internal and external stakeholders and multidisciplinary teams to advance our clinical programs. This position requires a high degree of professionalism, organization, and the ability to be resourceful and think fast.
ABOUT CYBIN:
Cybin is a remote-based workplace that operates internationally and is growing daily. This growth provides numerous opportunities for advancement and development, making it an exciting time to join our team. We work across multiple time zones and with various internal and external partners. Our core values are the backbone of our business and guide our hiring process: we are a team of disciplined, high-performing, and results-oriented people who strive for excellence in our execution. Our mission is to revolutionize mental healthcare by developing differentiated, next-generation therapeutics.
OBJECTIVES:
- Assists in creating and managing a development program across all associated Chemistry, Manufacturing, and Control (CMC), preclinical and clinical areas
- Ability to manage multiple studies simultaneously
- Establish a close partnering relationship with functional leaders to ensure strategic and operational alignment for all aspects of the development process
- Act as a point of escalation for early pipeline issues and risks. Ensure appropriate visibility and support the teams' response and risk management planning
- Assists in developing of the overall Project Plan and drives the results necessary to advance the molecules to the next phase of development (Preclinical - Clinical - Registration), including risk identification and mitigation strategies
- Provides strategic guidance to teams through the creation, governance approval, and execution of studies
- Provides financial oversight and collaborates closely with accounting and finance teams to review, track and project financial activities related to study vendors and partners
- Provides the overall demonstrable leadership, engagement, communication, planning and execution necessary to drive the development program forward
- Any additional duties which may be assigned from time to time
COMPETENCIES:
- Proficiency with Microsoft Office Suite
- Excellent follow-up and follow-through skills
- Excellent organizational, multitasking, and time management skills
- Excellent attention to detail and problem-solving skills
- Excellent written and verbal communication abilities
- Commitment to working independently with minimal supervision
- Commitment to handling confidential information with discretion
EDUCATION AND EXPERIENCE
- Bachelor’s Degree required
- Minimum of 7+ years of experience in the biotechnology/ pharmaceutical industry within a clinical project or program management, with a comprehensive understanding of overall study management
- Knowledge of global regulatory and compliance requirements for clinical research, including but not limited to Case Report Forms (CFR), International Council for Harmonization (ICH), Good Clinical Practices (GCP)
- Experience in developing study budgets, forecasting, managing financial oversight
- Team leadership experience within a cross-functional matrix environment
- Experience managing phase 3 global clinical trials (neuroscience experience preferred), including selecting and managing multiple study vendors, Contract Research Organizations (CRO), and clinical study teams
- Proficient in the creation, review, and approval of clinical study documents, including but not limited to Informed Consent Forms (ICF), study manuals, forms, plans, and templates
- Proven ability to maintain inspection readiness for Trial Master Files (TMFs), sites, and studies through regular audit reviews, prompt resolution of inspection findings, and overall study management
- Strong initiative, attention to detail, effective in a fast-paced work environment, proactive prioritization
- Desire and ability to work within an agile and cohesive team-based structure
- Demonstrated excellent communication (oral and written), teamwork, organizational, interpersonal, and problem-solving skills
- Ability to travel globally is required, including attendance at conferences, site visits, team meetings, etc.
PHYSICAL REQUIREMENTS
- Prolonged periods sitting at a desk and working on a computer
- Travel 1-2x per year
BENEFITS
- Medical, Dental & Vision Coverage
- Health Spending Account
- Retirement Savings Plan
- Internet and Mobile monthly stipend
- Paid Time Off
- Mandatory Office Closure December 25 – January 1 inclusive
COMMITMENT TO DIVERSITY:
As an Equal Opportunity Employer committed to meeting the needs of a multigenerational and multicultural workforce, Cybin Inc. recognizes that a diverse staff, reflective of our community, is an integral and welcome part of a successful and ethical business. We hire talent at all levels regardless of 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 accommodations during the recruitment process. Should you require accommodation, please contact us at HR@cybin.com and we will work with you to meet your accessibility needs. We appreciate all applications however, only those candidates selected for an interview will be contacted.
If this position caught your eye, send us your resume! For best consideration, include the job title and source where you found this position in the subject line of your email to HR@cybin.com.
