Associate Director, Investigator Sponsored Research, Medical Affairs

General Scope and Summary

SAGE Therapeutics is searching for a creative, resourceful, integrative thinker to support operational success within Medical Affairs. This position will function under the guidance and direction of the Director, Medical Operations. The successful candidate will be independent and proactive, but also a team player who is motivated by their contributions to the success of not only the Medical Affairs team, but Sage overall.

The Associate Director, Investigator Sponsored Research (ISR) independently leads all aspects of Investigator Initiated Research (IIR) and Collaborative Research.

Roles and Responsibilities

• Lead the cross-functional review of study protocols, budgets, informed consents, database structure, and other study management plans.

• Ensure internal project-related activities and/or interactions with study sponsors comply with applicable guidelines and regulations governing externally sponsored studies.

• Ensure assigned projects are resourced properly and executed within budget tolerances and in accordance with established timelines and quality expectations.

• Manage internal stakeholder expectations for assigned studies (e.g., information requests from cross-functional strategic committees and study updates for Medical Affairs stakeholders).

• Lead and process required approvals for assigned studies at governance committees (e.g., concepts, protocols, budgets, etc.).

• Manage interactions with study sponsors, ensuring appropriate cross-functional representation for any given topic.

• Manage project core and extended team interactions for assigned studies in order to align on recommendations and requests for study sponsors.

• Lead cross-functional approach to ensure ISR operational efficiencies when working with alliance partners.

• Lead and coordinate cross-functional efforts during transfers of study data for quality assurance measures and regulatory initiatives.

• Drive timelines for assigned studies.

• Assess risks and obstacles to study performance and provide options for resolution.

• Propose solutions for system improvement and information flow.

• Contribute to group, departmental, and/or organizational process improvement initiatives.

• Provide support and coverage for other Data Generation programs within Medical Affairs Operations if assigned.

• Perform safety reporting in alignment with all Sage policy/SOP requirements.

• Provide Early Access program oversight as needed per development portfolio lifecycle.

Experience, Education and Specialized Knowledge and Skills

Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, and efficient. Must have excellent interpersonal skills, the ability to develop important relationships with key stakeholders, the ability to identify issues and raise to key stakeholders in order to develop relevant and realistic plans, programs, and recommendations, and good conflict resolution skills.

Basic Qualifications

• Bachelors degree.

• 8+ years of experience in clinical research (e.g., Study Management, Project Management, Clinical Research Science, CRA/Monitoring, and Study Site Management).

Preferred Qualifications

• Masters degree with 6+ years of experience in clinical research.

• Ability to articulate technical and scientific information in a clear manner with partners and external stakeholders.

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

• Working knowledge of pharma regulatory and compliance rules, codes, and regulations.

• Experience implementing or oversight over a grant management or research system.

• Experience working with all levels of management and consulting with key business stakeholders. An ability to influence for greater outcomes through excellent communication and organizational skills.

• 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.