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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

  • Master’s 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.

Benefits and Compensation

The base salary hiring range for this position is $169,728 - $233,376.*

  • 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 Company’s 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.
*Base salary ranges are periodically reviewed and subject to change.

Job ID: R001927

#Biotechnology #Careers #ThisIsSage

All Sage new hires will be required to provide documentation that they are fully vaccinated against COVID-19 or, if not, that they are legally entitled to an accommodation due to a medical condition or a sincerely held religious belief.  Requests for accommodation will be considered on a case-by-case basis, and Sage will consider, among other things, whether the proposed accommodation would create an undue hardship.

All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.


Equal Opportunity Employer. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.

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We value our relationships with professional recruitment firms. To protect the interests of all parties, and given the large volume of inquiries received from third-party placement agencies, we are not able to respond to all agency inquiries. We do not accept unsolicited resumes from any source other than directly from candidates for current or future positions. Submission of unsolicited resumes in advance of a signed agreement between our company and a placement agency does not create an implied obligation and, if an unsolicited candidate represented by a placement agency is hired, we are not obligated to pay a fee. Only approved recruitment firms will be allowed to provide services to Sage Therapeutics, Inc.

Employment applications

Employment applications are processed through a website that is not owned or controlled by Sage Therapeutics, Inc. Sage Therapeutics, Inc. makes no representation as to the accuracy of the information contained on websites it does not own or control. Sage Therapeutics, Inc. does not recommend and does not endorse the content of any third-party websites. Your use of third-party websites is at your own risk and subject to the terms and conditions of use for such sites.


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