Job Description
Note: The job is a remote job and is open to candidates in USA. Helus Pharma is a late-stage neuropsychiatry company focused on revolutionizing mental healthcare through innovative therapeutics. The Director of Global Clinical Operations will lead the design and execution of clinical pharmacology studies, ensuring high-quality delivery and regulatory compliance while developing scalable processes for the clinical portfolio. Responsibilities • 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 • 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 • 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 • 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 • 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 • 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 Company Overview • Helus Pharma is a biopharmaceutical company that develops psychedelic therapeutics for mental health conditions. It is a sub-organization of Clarmin. It was founded in 2019, and is headquartered in Toronto, Ontario, CAN, with a workforce of 51-200 employees. Its website is Apply tot his job
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