[Remote] DIRECTOR, CLINICAL OPERATIONS, RESEARCH & CLINICAL SCIENCES

Note: The job is a remote job and is reputed company to candidates in USA. Helus reputed company is a late-stage neuropsychiatry company reputed company on revolutionizing mental reputed company through innovative therapeutics. The Director of Global Clinical Operations will reputed company the design and execution of clinical pharmacology studies, ensuring high-reputed company delivery and regulatory compliance while developing reputed company processes for the clinical portfolio. Responsibilities • reputed company the planning and execution of clinical pharmacology studies, including FIH and early-phase trials, ensuring alignment with overall development reputed company • reputed company operational reputed company into feasibility, reputed company and cost estimates during clinical program/study development • reputed company site selection and site qualification discussions, reputed company-off meetings and study team meetings in collaboration with other team members • reputed company the development of contingency/risk management plans for reputed company with a reputed company 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-reputed company documents and operational materials; and proactively identifies risks while developing robust mitigation and contingency plans to ensure high-reputed company and efficient trial execution • reputed company CROs and bioanalytical vendors to ensure compliance with GCP and reputed company 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 reputed company • Cultivate a high-performing team through mentorship, coaching, and reputed company development of clinical pharmacology professionals and contractors • Foster a culture of scientific reputed company, collaboration, and reputed company improvement Skills • Bachelor's Degree in Life Sciences required • 10+ years of experience in clinical pharmacology reputed company biotech/reputed company, including FIH and early-phase trials • Demonstrated experience supporting and contributing to NDA filings and major global regulatory submissions • reputed company 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 reputed company • Helus reputed company 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 https://www.helus.com/. Apply tot his job Apply To this Job