The Director Clinical Strategy is responsible for assisting clients with clinical strategy related development activities of drug, biologic or medical device products. He/she leads, develops and coordinates the activities of the Clinical Strategy team; ensures timely preparation of organized and scientifically valid quality deliverables; translates regulatory requirements into practical, workable plans and may lead or participate in Health Authority (HA) interactions as subject matter expert. Responsibilities may include provision of strategy, review and authoring of clinical/scientific documents. The Director Clinical Strategy is knowledgeable in overall drug development process.
The Director Clinical Strategy will serve on project teams in various capacities including, but not limited to: Subject Matter Expert, Technical Lead, Assistant Consulting Project Lead, and Consulting Project Lead. The Director Clinical Strategy may have one or more direct reports.
The Director Clinical Strategy is responsible for the following tasks:
• Reviews and/or writes clinical/scientific documents or sections thereof, with efficiency, accuracy, and independent thought
• Has advanced knowledge of HA Regulatory Guidance & Regulations pertaining to clinical strategy through all phases of drug or device development and lifecycle management
• Reviews and prepares HA questions and briefing documents.
• Attends / may lead HA meetings as Clinical Strategy SME
• Provides strategic advice and expertise in translating clinical requirements into practical plans and solutions
• Has advanced knowledge of CTD format and structure for regulatory submissions
• Contributes to Due Diligence Reviews / reports
• Learns and keeps abreast of updates to regulatory guidance, law, and best practice related to job functionality
• Mentors less experienced Clinical Strategy Scientists
• Participates in interdepartmental communications to assist with compliance with regulations.
• Takes accountability for responsibilities in area of expertise
• Performs other scientist related duties as assigned
Director with and without direct reports:
• Actively supports staff learning & development within the company
• Provides guidance and advises Project Leads, and/or Project Teams
• Adherence to project budgets and contracts including scope and scope changes, timeline deliverables and active management of resources
• Manages projects as a Technical Lead as assigned
• Leads and/or participates in meetings with clients
• Provides mentorship to team members
• Acts professionally with peers and clients, knows business etiquette
• Requires a B.Sc., M.Sc., Ph.D., or equivalent degree, in a scientific area, and equivalent combination of relevant experience in drug, biologic, or device development
• Advanced scientific and regulatory knowledge of drug, biologic, or device development
• Critical thinking and analytical skills, as well as strong written and verbal communication skills in English
• Strong computer skills, including, Word, Excel, and PowerPoint
• Quality focus
• Strong emotional intelligence, customer focused leadership and decision-making skills
• Innovative, creative, and practical thinking including problem-solving skills
• >8 years’ experience with regulatory requirements of US FDA, Health Canada and/ or European authorities