Stoke is seeking an enthusiastic and highly motivated Associate Director to join the Clinical Operations group. The successful candidate will be responsible for leading clinical trial(s) and a team to make key decisions related to the overall clinical trial execution strategy.
Key Responsibilities Include:
- Independently leads projects with focus on successful delivery of trials within time, quality, and budget expectations while adhering to strategy and performance against key metrics and corporate goals.
- Understands the broader industry and uses knowledge of competitive environment to drive efficiency and sense of urgency through trial(s) while maintaining high quality standards
- Sets the standard for trial management at Stoke by demonstrating a high level of knowledge of clinical operations’ methodologies, organizational, project management and leadership capabilities as well as increased strategic insight, decisiveness, and strong judgment
- Leads cross-functional Clinical Study Team meetings
- Makes certain that there is appropriate identification and ongoing assessment of risks and risk mitigation to ensure integrity of programs and to maintain trial progress
- Works closely with Clinical Development staff and peers to ensure that study plans are aligned and in support of broader goals and objectives and that there is consistency in approach to management of clinical trial programs
- Ensures that multiple, novel ideas on how to deliver on clinical trials are generated and considered
- Builds and implements resource planning and management skills, processes and standards while using an understanding and knowledge of different clinical phase requirements to ensure effective resource management across trials
- Oversees and manages CRO and multiple vendors including budgets and timelines
- Ensures outsourced resources, technology and procedures used by external partners, vendors or CROs align with resourcing needs within Clinical Operations
- Ensures the voice of the patient is represented in the planning, design and conduct of clinical trials
- Identifies opportunities and leads initiatives to streamline processes and enhance productivity, efficiency and quality of outputs for Clinical Operations
- Minimum 5-7 years of industry experience.
- Bachelor’s Degree in a health related or scientific discipline is required.
- Minimum 4 years managing clinical studies.
- Proven track record in resource planning, forecasting, and budgeting.
- Expertise in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP.
- Rare Disease experience preferred but not required.
- Demonstrates extensive clinical trials experience.
- Demonstrates excellence in complex trial management, effective management of multiple projects/priorities, vendors and budgets.
- Demonstrates understanding of pharmaceutical regulatory requirements and strategic implications for clinical development operations.
- Demonstrates ability to lead multifunctional teams, mentor and coach junior staff.
- Excellent organizational, verbal, written and presentation skills.