EPM Scientific - Phaidon International
Director of Clinical Operations
EPM Scientific - Phaidon International, Cambridge, Massachusetts, us, 02140
Title: Director of Clinical OperationsSalary:
$220,000-$235,000Company Summary:
This hot biotech has raised $1 billion dollars in funding since being founded in 2016. They are the first targeted protein degradation (TPD) biotech of its kind. Their goal is to reinvent the treatment of diseases, hoping to reach the patients that have not been reached before. This company is nearing phase three and looking to expand their clinical operations team. This will give you the opportunity to join right before explosive growth.The Director of Clinical Operations will be responsible for:Direct and manage the strategic planning, implementation, and execution of clinical trials for a key immunology program, ensuring compliance with project timelines, budgets, and quality standards.Collaborate with various internal teams, such as Clinical Development, Regulatory Affairs, Biostatistics, Translational Medicine, and Program Leadership, to align on clinical trial objectives and milestones.Serve as the primary contact for CROs and vendors, managing their performance to ensure they meet contractual obligations, timelines, and quality benchmarks.Prepare and review clinical study documents, such as the Investigator Brochure, Investigational New Drug Applications (IND), study protocols, clinical study reports, and relevant sections of New Drug Applications (NDA) and Marketing Authorization Applications (MAA), including updates and safety reports.The Director of Clinical Operations should have the following qualifications:10-12 years of clinical trial experience, with 5-7 years leading global trials.Oncology, immunology, and inflammatory disease experience.Building and leading clinical operations teams.Benefits:Wide range of benefits covered by the company (health, dental, HSA, vision, life, mental health, disability).Hybrid work schedule with three days in office, two days remote.Culture of constant improvement and commitment to meet employee's needs.If you are interested in the Director of Clinical Operations role, please don't hesitate to apply.
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$220,000-$235,000Company Summary:
This hot biotech has raised $1 billion dollars in funding since being founded in 2016. They are the first targeted protein degradation (TPD) biotech of its kind. Their goal is to reinvent the treatment of diseases, hoping to reach the patients that have not been reached before. This company is nearing phase three and looking to expand their clinical operations team. This will give you the opportunity to join right before explosive growth.The Director of Clinical Operations will be responsible for:Direct and manage the strategic planning, implementation, and execution of clinical trials for a key immunology program, ensuring compliance with project timelines, budgets, and quality standards.Collaborate with various internal teams, such as Clinical Development, Regulatory Affairs, Biostatistics, Translational Medicine, and Program Leadership, to align on clinical trial objectives and milestones.Serve as the primary contact for CROs and vendors, managing their performance to ensure they meet contractual obligations, timelines, and quality benchmarks.Prepare and review clinical study documents, such as the Investigator Brochure, Investigational New Drug Applications (IND), study protocols, clinical study reports, and relevant sections of New Drug Applications (NDA) and Marketing Authorization Applications (MAA), including updates and safety reports.The Director of Clinical Operations should have the following qualifications:10-12 years of clinical trial experience, with 5-7 years leading global trials.Oncology, immunology, and inflammatory disease experience.Building and leading clinical operations teams.Benefits:Wide range of benefits covered by the company (health, dental, HSA, vision, life, mental health, disability).Hybrid work schedule with three days in office, two days remote.Culture of constant improvement and commitment to meet employee's needs.If you are interested in the Director of Clinical Operations role, please don't hesitate to apply.
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