Join the Sage Team!
- Thrive working in a dynamic environment
- Share our passion for science
- Have the drive to make a big difference in the lives of patients with CNS disorders
Join our team!
Following are some of the positions for which we are currently hiring. If you would like to be considered for one of these positions, please submit your resume/CV via email to: firstname.lastname@example.org
- Clinical Research Associate, Clinical Operations and Development
- Senior Staff Accountant
- Director, Investor Relations
- Head of Regulatory Affairs
Please contact us at email@example.com to learn more about career opportunities at SAGE Therapeutics or if you know somebody whom you feel would be interested in joining the team!
Clinical Research Associate
We seek a motivated, flexible, and enthusiastic clinical research professional interested in joining our fast-paced company to support multiple studies. The primary responsibility of the Clinical Research Associate will be to assist in study management activities, maintain the eTMF, and monitor clinical investigative sites as needed. The Clinical Research Associate will report to the Director, Clinical Operations and Development, and must have at least 2 years of experience monitoring IND-regulated, clinical research studies (Phase I-III).
- Assists in start-up activities of clinical research studies including Investigator Meetings, enrollment planning, and Investigator selection;
- Leads the management of the eTMF for all clinical studies;
- Collaborates closely with Sage study management, CRO study managers, and CRO monitoring staff, reviews site/patient activity tracking, and prepares study updates;
- Regularly communicates with Investigators to identify and resolve complex clinical study conduct issues and ensures site compliance with Good Clinical Practice, and federal and applicable local regulatory requirements;
- Monitors phase I – III site visits, including site qualification, initiation, interim, close-out visits, and co-monitoring, as needed based on the trial needs (average 10% travel, with peaks of up to 30% travel);
- Guides investigative site activities at multiple clinical trial sites, including SAE reporting, identification of protocol deviations, essential document status, eCRF completion, and investigational product accountability;
- Reviews and provides input to study plans and guidelines, including study monitoring plans;
- Assists in development of study documents, such as informed consent forms, study logs, and study manuals;
- Provides guidance and training to CRO Clinical Research Associates.
- BS required; Master’s degree preferred. At least 4 years of experience in the pharmaceutical industry required. All candidates must have at least 2 years of experience monitoring IND-regulated, clinical research studies (Phase I-III), ICU monitoring experience preferred;
- Must have thorough understanding of GCP and ICH regulations, clinical trial monitoring, and regulatory compliance;
- Demonstrated effectiveness in resolving site management issues of varying complexity;
- Candidate will bring a high level of organization, possess exceptional planning abilities, be self-motivated, and have a high attention to detail;
- Must be able to adapt in real-time to changing program needs;
- Must be flexible, collaborative, and a “team player”.
Head of Regulatory
SAGE Therapeutics is seeking a Head of Regulatory to provide leadership and strategic expertise in regulatory processes, laws, and regulations. Reporting to the Chief Medical Officer, the Head of Regulatory will be a key contributor in building a regulatory function with both the depth and breadth to develop strategies that lead to global approvals of our products. Successful candidate will be responsible for creating regulatory development plans and for successful execution against those plans. To be successful in this role, individual will be self-motivated, must have a strong work ethic and integrity. Additionally, individual must possess outstanding communication skills (both verbal and written) and be able to build relationships and influence decision-making, while managing to tight timelines.
The candidate will be expected to thrive in a fast paced, dynamic, and nimble environment of an emerging start-up company that depends on strong links and collaboration with contract research organizations, academia and nonprofit organizations.
ESSENTIAL JOB FUNCTIONS*
- Serve as regulatory leader for CNS/Neurology products at various stages of development
- Prepare INDs, NDAs, CTAs, annual reports, amendments
- Develop and create strategy for long-term planning at a cross functional level for product, consistent with the corporate and project objectives
- Represent regulatory in senior management discussions and present issues accordingly
- Provide guidance to teams in support of global clinical trials
- Prepare teams for regulatory interactions
- Engage with regulatory agencies on project related matters
- Identify issues proactively that will impact programs and provide strategies to address them and communicate to the project team
- Provide insight and guidance on implementation of regulations with respect to the preparation and submission of regulatory documentation as well as the design of clinical trials
- Drive decision making in the cross functional teams with respect to regulatory issues
- Create regulatory submission timelines in collaboration with cross functional teams
- Manage internal team and external consultants/vendors to regulatory timelines
- Create regulatory development plan
Must thrive working in a fast paced innovative environment while remaining flexible, proactive, resourceful and efficient are essential. Must excel in a multidisciplinary environment as an integral leader and team member across several project teams. Ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations. Excellent written and verbal communication skills, strong problem solving ability, and attention to detail and quality are critical to success.
PREPARATION, KNOWLEDGE, SKILLS & ABILITIES
- B.S. in a scientific discipline required; advanced degree preferred
- Extensive experience with FDA in Neurology, Anesthesia and/or Psychiatry divisions required
- Orphan drug/fast-tracking experience highly preferred
- Must have 10+ years pharmaceutical industry experience in regulatory affairs
- CMC and international regulatory issues required
- Excellent organizational and communication skills, both written and verbal
- Ability to work independently as well as part of a team environment
- Proven ability to manage multiple projects, identify and resolve regulatory issues
- Strong interpersonal skills and the ability to effectively work with others
- Ability to influence without authority, lead change and manage resistance to change.
- Must be able to solicit information, persuade others and shape outcomes.
- Demonstrated strong scientific reputation as evidenced by strong publication record.
Sage Therapeutics is a wholly virtual biotech company. Ideal candidate must have the passion and ability to forge and nurture key partnerships and collaborations with the external scientific community, including academia, governmental organizations, nonprofit organizations and CROs.
Seeking a highly motivated and detail oriented Staff Accountant/Payroll professional to join our growing Finance and Accounting team. This is a visible and critical role and is an outstanding opportunity for an emerging accountant looking to join a dynamic finance team.
Working with our finance and accounting team, this person will be responisble for:
- Ensuring timely and accurate processing of invoices in accordance with company policies
- Coordinate 1099 tax reporting
- Working with cross-functional team members to investigate and resolve AP and purchasing issues
- Coordinating with multiple departments to acquire proper invoice approvals
- Managing weekly check runs, along with overseeing the signing and mailing of checks
- Assisting in the montly financial close process
- Processing bimonthly employee payroll
- Other support duties within the finance department as needed
Successful candidate will have:
- BS degree and 3-5 years payables experiecne; biotech industry experience highly preferred
- High degree of accuracy when completing tasks with strong organizational and analytical skills
- Excellent problem solving, follow up, and customer service skills
- Experience with ADP and QuickBooks essential
- Strong computer skills
- Outstanding verbal and written communication skills
- Ability to multi-task and meet deadlines.
Note to Employment Agencies: Please do not forward any agency resumes. SAGE Therapeutics is not responsible for any fees related to resumes that are unsolicited.
SAGE Therapeutics will only accept job applications from candidates who are properly documented with authorization to work in the United States.
*External and internal applicants, as well as position incumbents who become disabled as defined under the Americans with Disabilities Act must be able to perform the essential job functions (as listed) either unaided or with the assistance of a reasonable accommodation to be determined by management on a case by case basis.