Director, Clinical Systems

General Scope and Summary

Sage Therapeutics is searching for a Director, Clinical Systems who will ensure that electronic clinical systems and related processes are in place to support high quality, compliant, end-to-end management of Phase 1 - 4 interventional clinical trials. This role leads the collaboration between Clinical Operations, Digital & Enterprise Capabilities (DEC), and Quality Systems relative to the selection, implementation, and lifecycle management of external (vendor-owned) systems in alignment with regulatory requirements and Sage business goals.

Roles and Responsibilities

• Lead Clinical Systems strategy development relative to selection, implementation, and quality oversight for vendor-owned clinical systems, exclusive of EDC.

• Partner with stakeholders throughout the full lifecycle of external clinical systems integration, including scope definition, vendor selection, configuration, deployment, and management and oversight of compliance requirements.

• Lead the analysis of business processes, propose solutions for current and future needs, and implement recommended improvements in accordance with Sage operating standards.

• Ensure systems are properly implemented and operated to achieve and maintain GxP validation, including review of validation documentation, execution of testing, and coordinating change management and related processes.

• In partnership with DEC and Research Quality Assurance/Quality Systems, ensure system documentation is developed and maintained including, but not limited to, system specifications, user acceptance testing plans, SOPs and training plans, and validation records.

• Oversee the development of operational workflows and ensure users are appropriately trained.

• Work with functional leaders to align on key measures and metrics for success.

• Drive innovation and the delivery of continuous process improvement.

• Optimize and implement Standard Operating Procedures (SOPs), policies, processes, communication, and infrastructure to ensure Sage is a quality-driven organization.

Experience, Education and Specialized Knowledge and Skills

Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, and efficient. Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans, programs, and recommendations. Must have a demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues in a simple way, and orchestrate plans to resolve issues and mitigate risks.

Basic Qualifications

• BS/BA degree.

• 8+ years of pharmaceutical or biotechnology industry experience or equivalent.

• 8+ years of experience working in the clinical environment managing clinical systems (eCOA, IRT, CTMS).

• PC literacy required, including fluid use of common Microsoft applications.

Preferred Qualifications

• Masters degree or above.

• 12+ years of pharmaceutical or biotechnology industry experience or equivalent.

• Extensive knowledge of ICH-GCP guidelines, 21 CRF Part 11, and Health Authority regulations/expectations as they pertain to the use of electronic systems in clinical studies.

• Experience working with all levels of management, and consulting with key business stakeholders. An ability to influence for greater outcomes.

• Excellent planning, organizational, and time management skills, including the ability to support and prioritize multiple projects, both working independently and within a team.

• Flexibility to adapt to the dynamic needs of a growing biotech company and to manage change effectively.

• Ability to learn quickly and adjust approach to problems based on feedback.

• Demonstrated experience working in a matrix environment.

• Strong team player that has a customer service approach and is solution oriented.

• Experience in developing business specifications/requirements and user acceptance testing for computer systems.

• Experience with vendor management and oversight of data exchange, migration, and integration.

• Embrace our core values: Put People First, Improve Lives, Cultivate Curiosity, Do Right, and Forge New Pathways.

• Excitement about the vision and mission of Sage.

• The actual salary offered within the range is dependent on a variety of factors including, but not limited to, relevant experience, qualifications, education, skills, and performance.
• This position is eligible to participate in the Companys annual bonus plan; the bonus varies based on performance and is subject to the standard terms and conditions of the incentive program.
• To support your well-being, we offer a comprehensive benefits and wellness package, which includes medical, dental, and vision coverage upon hire. More information can be found in our Benefits Guide.