Job Title: Director of Clinical Affairs & Operations
Location: Miami, Florida (hybrid, open to remote)
Job Type: Full-Time
Salary: $250,000-$275,000
About Us:
We're partnering with a clinical-stage biotechnology company focused on developing novel antiviral therapeutics. Their mission is to create first and best-in-class antiviral drugs using a unique structure-based drug discovery technology platform. Their pipeline is rapidly advancing several programs, with clinical trials in progress for influenza, norovirus, and coronaviruses. Additionally, they are actively discovering and developing antiviral compounds for other significant indications.
Position Summary:
The Director of Clinical Affairs & Operations will lead the strategic and regulatory aspects of our clinical research programs. This role requires a deep understanding of clinical operations, regulatory requirements, and the ability to drive clinical strategy to support our antiviral therapeutic programs.
Key Responsibilities:
Oversee the planning and execution of clinical trials from initiation to completion.
Prepare and submit documents to regulatory authorities to gain approval for clinical trials and marketing of new drugs.
Ensure all clinical activities comply with regulatory requirements and ethical standards.
Develop and implement clinical development plans and strategies.
Communicate clinical data to healthcare professionals and stakeholders, and support post-marketing studies and phase IV trials.
Manage and lead the Clinical Operations team, including recruitment, training, and performance evaluation.
Work closely with other departments such as Regulatory Affairs, and Research & Development.
Identify and assess risks, and implement preventative measures.
Allocate and manage budgets for clinical affairs activities.
Build and maintain relationships with external entities such as regulatory bodies, key opinion leaders, and clinical investigators.
Generate and present reports on clinical affairs activities to senior management and stakeholders.
Qualifications:
10 years of experience in clinical affairs/operations on the sponsor side.
5 years of leadership experience.
Experience with infectious disease trials and research.
Experience with phase I and II trials.
Proven track record of successful regulatory submissions and clinical strategy development.
Strong knowledge of regulatory requirements and ethical standards in clinical research.
Excellent leadership, communication, and interpersonal skills.
Ability to work collaboratively with cross-functional teams.
Strong problem-solving and decision-making abilities.
Benefits:
Competitive stock options and bonus.
Opportunity to work with a dynamic and innovative team.
Competitive benefits (401k, health insurance, PTO).