[Remote] DIRECTOR, CLINICAL OPERATIONS, RESEARCH & CLINICAL SCIENCES
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
ā¢ Lead the planning and execution of clinical pharmacology studies, including FIH and early-phase trials, ensuring alignment with overall development strategy
ā¢ Provide operational insight into feasibility, timeline and cost estimates during clinical program/study development
ā¢ Lead site selection and site qualification discussions, kick-off meetings and study team meetings in collaboration with other team members
ā¢ Lead the development of contingency/risk management plans for projects with a focus on ensuring studies deliver according to principles of GCP
ā¢ Collaborate with Clinical Development, Regulatory, and Biostatistics to ensure integrated study plans and regulatory readiness
ā¢ 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
ā¢ Oversee CROs and bioanalytical vendors to ensure compliance with GCP and quality standards
ā¢ Implement risk-based monitoring and centralized data review strategies for clinical pharmacology endpoints
ā¢ Represent Clinical Pharmacology operations on project teams and governance committees
ā¢ Partner with Global Clinical Operations to ensure seamless integration of pharmacology components into clinical trials
ā¢ Cultivate a high-performing team through mentorship, coaching, and professional development of clinical pharmacology professionals and contractors
ā¢ Foster a culture of scientific excellence, collaboration, and continuous improvement
Skills
ā¢ Bachelor's Degree in Life Sciences required
ā¢ 10+ years of experience in clinical pharmacology within biotech/pharma, including FIH and early-phase trials
ā¢ Demonstrated experience supporting and contributing to NDA filings and major global regulatory submissions
ā¢ Standard use of Project Management skills including teamwork, analytical and problem-solving, time management and organizational skills, risk and cost management, and performance monitoring
ā¢ Strong knowledge of global regulatory requirements and GCP
ā¢ Excellent communication, leadership, and problem-solving skills
Company Overview
ā¢ 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 https://www.helus.com/.
Apply Now
Apply Now
Responsibilities
ā¢ Lead the planning and execution of clinical pharmacology studies, including FIH and early-phase trials, ensuring alignment with overall development strategy
ā¢ Provide operational insight into feasibility, timeline and cost estimates during clinical program/study development
ā¢ Lead site selection and site qualification discussions, kick-off meetings and study team meetings in collaboration with other team members
ā¢ Lead the development of contingency/risk management plans for projects with a focus on ensuring studies deliver according to principles of GCP
ā¢ Collaborate with Clinical Development, Regulatory, and Biostatistics to ensure integrated study plans and regulatory readiness
ā¢ 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
ā¢ Oversee CROs and bioanalytical vendors to ensure compliance with GCP and quality standards
ā¢ Implement risk-based monitoring and centralized data review strategies for clinical pharmacology endpoints
ā¢ Represent Clinical Pharmacology operations on project teams and governance committees
ā¢ Partner with Global Clinical Operations to ensure seamless integration of pharmacology components into clinical trials
ā¢ Cultivate a high-performing team through mentorship, coaching, and professional development of clinical pharmacology professionals and contractors
ā¢ Foster a culture of scientific excellence, collaboration, and continuous improvement
Skills
ā¢ Bachelor's Degree in Life Sciences required
ā¢ 10+ years of experience in clinical pharmacology within biotech/pharma, including FIH and early-phase trials
ā¢ Demonstrated experience supporting and contributing to NDA filings and major global regulatory submissions
ā¢ Standard use of Project Management skills including teamwork, analytical and problem-solving, time management and organizational skills, risk and cost management, and performance monitoring
ā¢ Strong knowledge of global regulatory requirements and GCP
ā¢ Excellent communication, leadership, and problem-solving skills
Company Overview
ā¢ 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 https://www.helus.com/.
Apply Now
Apply Now