ABOUT THE COMPANY
Helus Pharma (NASDAQ: HELP) is a late-stage neuropsychiatry company dedicated to revolutionizing mental healthcare. Through the development of innovative next-generation therapeutics, Helus Pharma aims to address the significant unmet needs of people affected by depression, anxiety, and other mental health conditions. Founded in 2019, the company operates in Canada, the United States, the United Kingdom, the Netherlands, and Ireland.
With promising data from its lead programs, HLP003—a proprietary deuterated psilocin analog currently in Phase 3 (with U.S. Food and Drug Administration Breakthrough Therapy Designation) for the adjunctive treatment of major depressive disorder—and HLP004, a deuterated DMT in Phase 2 for generalized anxiety disorder, Helus Pharma is set to transform the mental health treatment landscape. The company’s robust research pipeline of 5-HT-receptor-focused compounds has the potential to redefine the treatment of neuropsychiatric conditions.
Supported by strong proof-of-concept data and a global team of scientists, clinicians, and mental health innovators, Helus Pharma is well-positioned for growth through thoughtfully engineered intermittent therapies that deliver durable, meaningful outcomes. Driven by compassion and the urgent need for better mental health solutions, Helus Pharma is building a pathway to make accessible, scalable, and transformative care available to millions of people worldwide.
POSITION PURPOSE
The Director of Global Clinical Operations will provide leadership and overall strategic management for the design, execution, and interpretation of clinical pharmacology studies, including first-in-human (FIH), dose-ranging, and healthy subjects and patient pharmacology trials. This role ensures high-quality delivery of clinical pharmacology operational components across all phases of development, with a strong focus on scientific rigor, regulatory compliance, and operational excellence. Additionally, this leader will play a critical role in shaping and maturing the Phase 1 Clinical Operations organization by developing scalable processes, governance structures, and operational infrastructure that support a growing and evolving clinical portfolio.
CORE ACCOUNTABILITIES
Clinical Pharmacology Strategy & Execution:
- Lead the planning and execution of clinical pharmacology studies, including FIH and early-phase trials, ensuring alignment with overall development strategy.
- Provide operational insight into feasibility, timeline and cost estimates during clinical program/study development
- Lead site selection and site qualification discussions, kick-off meetings and study team meetings in collaboration with other team members.
- Lead the development of contingency/risk management plans for projects with a focus on ensuring studies deliver according to principles of GCP.
- Collaborate with Clinical Development, Regulatory, and Biostatistics to ensure integrated study plans and regulatory readiness.
Scientific Leadership:
- Leads the review and approval of study-related documents and operational materials; and proactively identifies risks while developing robust mitigation and contingency plans to ensure high-quality and efficient trial execution
Vendor & Quality Oversight:
- Oversee CROs and bioanalytical vendors to ensure compliance with GCP and quality standards.
- Implement risk-based monitoring and centralized data review strategies for clinical pharmacology endpoints.
Cross-Functional Collaboration:
- Represent Clinical Pharmacology operations on project teams and governance committees.
- Partner with Global Clinical Operations to ensure seamless integration of pharmacology components into clinical trials.
Leadership & Team Development:
- Cultivate a high-performing team through mentorship, coaching, and professional development of clinical pharmacology professionals and contractors.
- Foster a culture of scientific excellence, collaboration, and continuous improvement.
SKILLS AND QUALIFICATIONS
Qualifications:
- Bachelor's Degree in Life Sciences required.
- 10+ years of experience in clinical pharmacology within biotech/pharma, including FIH and early-phase trials.
- Demonstrated experience supporting and contributing to NDA filings and major global regulatory submissions
- Standard use of Project Management skills including teamwork, analytical and problem-solving, time management and organizational skills, risk and cost management, and performance monitoring.
- Strong knowledge of global regulatory requirements and GCP.
- Excellent communication, leadership, and problem-solving skills.