IT Director of Research & Development, Pre-Clinical (Information Technology)
Voyager Therapeutics (Nasdaq: VYGR) is a biotechnology company dedicated to breaking through barriers in gene therapy and neurology. The potential of both disciplines has been constrained by delivery challenges; Voyager is leveraging innovative expertise in capsid discovery and deep neuropharmacology capabilities to address these constraints. Voyager’s TRACER AAV capsid discovery platform has generated novel capsids with high target delivery and blood-brain barrier penetration at low doses, potentially addressing the narrow therapeutic window associated with conventional gene therapy delivery vectors. This platform is fueling alliances with Pfizer Inc., Novartis and Neurocrine Biosciences as well as multiple programs in Voyager’s own pipeline. Voyager’s pipeline includes preclinical programs in Parkinson’s disease, Alzheimer’s disease, and amyotrophic lateral sclerosis (ALS), each with validated targets and biomarkers to enable a path to rapid potential proof-of-biology. For more information, visit www.voyagertherapeutics.com.
The IT Director of Research & Development, Pre-Clinical will be responsible for technical architecture, strategic planning and execution of projects, operations and provide on-site support for infrastructure, technology, and software that support the R&D function. This role will be responsible for developing data governance and master data strategies. Also, responsible to identify technologies that will improve user satisfaction, reduce cost, improve efficiency on ongoing basis. Establish, monitor, and analyze performance metrics and service level agreements for IT operations to ensure R&D business needs are being properly met. Need to have demonstrate leadership and partner management skills to ensure all IT functions are delivered successfully whether they are provided internally or via outside vendors. The primary objective for this role is to define, design, build, and support R&D, Clinical and data analytics technologies that further the objectives of the R&D, Tech. Ops and Clinical departments.
Position Specific Responsibilities:
- Collaborate and partner with Internal Business Partner organizations to understand business priorities, data analytics needs and tools, and metrics to support them.
- Lead and serve as the Technical System owner for the applications in R&D and Clinical and own Data and all future data repository structures.
- Lead and oversee Enterprise/Data Architecture projects, standards, principles, and implementations for R&D, Tech. Ops. SaaS systems
- Ensures that appropriate governance is in place for successful evaluation and delivery of IT R&D projects.
- Work with computer systems validation team and Quality Systems management to review and assist audits of external facilities and systems.
- Perform planning, communicating, and advising foundational big data, advanced analytics, and AI/ML initiatives.
- Work with additional internal business functions (Bioinformatics, Quality, etc.) to expand current scope and functionality to better serve their current and future needs.
- Working in conjunction with IT Applications teams, refine and define our Master Data Management approach and processes to ensure end to end integration of our full applications and solutions portfolio.
- Manage IT R&D digital technology projects, integration and support as required. Exposure to Bhoomi ETL or other industry leading tools
- Provide continuous feedback to business partners regarding the priorities and status of work being performed within specified areas of the IT organization.
- Good knowledge or experience with AWS Redshift and Graph DB design and management.
- Working knowledge of Benchling will be a plus
- Working Knowledge on AWS Cloud technologies, mainly on the services of VPC, EC2 and S3 data lakes.
- Experience in AWS utilizing services such as AWS CLI, and DynamoDB
- Relational Data Warehouses, Data integration & Microservices, Business Intelligence and Big Data Analytics.
- Manage and guide the testing of business applications using appropriate methodologies and tools to improve quality, flexibility, and efficiency.
Specialized Knowledge & Skills:
- Strong understanding of modern enterprise cloud platforms and technologies
- Hands-on working knowledge of master data management methodologies and data governance models
- Demonstrated experience with application systems such as Business Intelligence
- Reporting platforms, Veeva Clinical Platforms, Master Data Management, Preclinical Data Management/ELN platforms, Document Management systems, or related systems is required
- In-depth knowledge of R&D, and Technical Operations functions within life sciences and demonstrated knowledge of the applied core technologies to enable these functions to operate efficiently is required
- Experienced in internal, external, regulatory, and Sarbanes-Oxley audit assessments.
- Understanding of data privacy regulations and laws
- Knowledge of FDA compliance principles FDA CFR21 Part11 and GxP computer system validation
- Ensures controls are in place for compliance in all IT standards and architectures.
- Demonstrated competence in key areas of leadership expertise including relationship management, communication, staff direction and motivation, financial planning and control, quality management, risk management, and the setting and achievement of targets, department and direct report goals
- A Master’s Degree in Computer Science, Information Systems, or related discipline
- 15 years of experience leading Information Technology initiatives, R&D applications and IT service delivery
- 5 years of experience in an IT leadership role with hands-on experience managing and leading multi-functional teams in a fast-paced biotech/pharma/life sciences setting is required