VP, Clinical Operations

SUMMARY:

This highly visible role is responsible for the leadership, oversight and execution of clinical trials ensuring they are completed according to timelines, budgets, and regulatory/corporate quality standards. The Vice President, Head of Clinical Operations will serve as a functional leader, line manager and subject matter expert for the internal Clinical Operations department, including clinical operations, data management, medical writing, clinical outsourcing, and clinical quality functions. The incumbent will work collaboratively with other senior/functional leaders in the achievement of departmental and corporate objectives and initiatives. With extensive industry knowledge and experience, the Vice President will proactively seek to improve the efficiency, effectiveness, and quality of Kriya’s clinical trial activities. The incumbent will ensure all clinical studies are conducted in accordance with company SOPs, GCPs and ICH guidelines.

RESPONSIBILITIES:

• Leadership role within Clinical Operations. Sits on cross-functional teams as a subject matter expert. Ensures quality and compliance are at the forefront of our work output.
• Responsible for managing internal Clinical Operations staff.
• May lead relevant team meetings as required.
• Provides strategic leadership and direction to all of Kriya’s clinical studies. Establishes an appropriate framework and oversight, including input into strategy, prioritization, reviews, and decision making to maximize the probability of achieving on-time and on-budget delivery of clinical programs.
• Identifies potential obstacles and propose innovative solutions; ensure adequate resources are implemented to ensure successful completion of projects.
• Proactively responds to the needs of other functions and influences appropriately to ensure the successful delivery of the portfolio. Successful delivery requires establishing strong relationships working in partnership with key stakeholders across Development, R&D, and Regulatory
• Seeks alignment within the organization to deliver outputs and achieve the overall strategy.
• Seeks to continually raise the bar for the operationalization of study teams, driving both timeline and resource efficiency, partnering cross-functionally for shared learning across the portfolio.
• Able to reallocate resources with ease in the face of changing priorities while remaining focused on innovation and streamlining processes.
• Brings a “can-do” attitude while being able to respectfully challenge partners and be assertive, when necessary, around project timelines, finances, and scope.
• Ensures the recruitment and development of the right talent and therapeutic area expertise to enable the appropriate level of strategic input into clinical program design and clinical study design. Responsible for the growth and development of talent within Clinical Operations organization.
• Provides oversight on project and/or program budgets.
• Communicate directly with senior management regarding progress of the project.
• Develops and implements strategic vendor selection and management/oversight program for the wide range of vendors to be used in clinical development. Is accountable for resolving vendor issues that need to be addressed at the executive level.
• Maintains an up-to-date industry knowledge and future trends in clinical development and operationalization of clinical trials.
• May lead and contribute to the review and revision of Clinical documents (e.g., protocols, study reference manuals, documents to be submitted to Regulatory agencies or ethics boards), Standard Operating Procedures, guidelines, and departmental policies.
• Oversee and assist in the preparation of protocols and Case Report Forms, monitoring and data management tools and other study documents.
• Oversee interactions of internal teams with other Site Managers, and Investigators to relay key study issues, status updates, and other study information.

REQUIREMENTS:

• Requires an advanced degree beyond a Bachelor of Science or equivalent experience in clinical operations management
• Minimum of 12 years’ experience in the planning and implementation or clinical trials, including project management
• Minimum of 10 years’ experience in drug development
• Experience in Study/Project Management within the pharmaceutical or CRO sector
• Demonstrated ability to effectively negotiate business terms and financial costs
• AAV gene therapy in Oncology and/or Ophthalmology experiences desirable
• High degree of customer focus for both internal and external customers and proven ability to build and maintain effective internal and external relationships
• Strong knowledge of Clinical Development, Contract Management, Project, and functional outsourcing management
• Previous supervisory experience required
• Strong communication skills, written and verbal
• Ability to facilitate conflict resolution
• Knowledge of applicable Regulatory Code of Regulations, Good Clinical Practices, and ICH guidelines and basic understanding of the phases of clinical development is required. Familiarity with the drug approval process through NDA/BLA is required.
• Maintains a high level of professional expertise through familiarity with regulatory and clinical literature and continuous education
• Receives no instructions on routine work, general instructions on new assignments.
• Leadership and interpersonal skills are a necessity. Must be able to facilitate and work in a team environment.
• Requires computer literacy in several software packages, especially Microsoft Office applications and database software.

WORKING CONDITIONS:

• Work is normally performed in a typical interior/office work environment
• Requires approximately 30% travel

This is an exciting time to participate in the field of gene therapy in general, and to become a part of Kriya Therapeutics’ fast-growing dedicated team. Kriya Therapeutics offers an exciting, meaningful and collaborative fast-paced environment with a foundation of sound and rigorous science. Competitive compensation and benefits package can be expected.