Sage Therapeutics

careers

Careers

 

 

If you are a CNS pharmacologist or chemist that shares our passion for science and our drive to make a big difference in the lives of patients with CNS disorders, please contact us at to learn more about career opportunities at SAGE Therapeutics.

Clinical Research Associate, Clinical Operations and Development

Job Description:

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).

 Responsibilities:

  • 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.

 Requirements:

  • 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”.

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Head of Regulatory

GENERAL SUMMARY 

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

 COMPETENCIES

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.

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Controller

Reporting to the CFO, this position oversees the entire internal and external accounting function and is responsible for overall day-to-day management of accounting and controls of this dynamic, high-growth company.  The role serves as a main focal point to ensure the accounting department serves the accounting needs of strategic partners, investors, the overall company and the various operating groups within the organization.  The position also ensures that the monthly, quarterly and annual financial, regulatory and management reporting is completed on a timely basis and in accordance with GAAP.

 POSITION RESPONSIBILITIES

 ·         Oversee the operations of the accounting department, including optimizing the departmental organizational structure and processes to achieve

          department’s goals and objectives.

 ·         Manage the accounting team.

 ·         Serve as primary contact for and manage external audit, valuation and tax service providers.

 ·         Drive financial and administrative projects, as needed.

 ·         Provide financial forecasts and analysis, as needed.

 ·         Implement and ensure adherence to accounting policies and procedures.

 ·         Identify opportunities to increase efficiencies and improve processes.

 ·         Develop and maintain internal controls for key processes and drive processes and controls towards SOX compliance.

 ·         Oversee equity accounting and third-party equity administration.

 ·         Manage financial information systems monitoring and controls.

  POSITION REQUIREMENTS (SKILLS, KNOWLEDGE, EDUCATION AND WORK EXPERIENCE)

 ·         Experience with SEC reporting required; Big Four public accounting experience preferred.

 ·         Bachelor’s degree and CPA required.

 ·         At least 8 years of relevant experience in both pre and post IPO bio/pharma environments required.

 ·         Thorough technical accounting knowledge of issues, procedures and practices.

 ·         Highly analytical with proven ability to identify and resolve problems with sound and accurate judgment

 ·         Initiative to take ownership of this key function; demonstrated hands-on execution skills.

 ·         Able to relate and communicate effectively with executive management as well as all other functions in the organization.

 ·         Excellent written and oral skills; proven management skills.

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Director/Senior Director Toxicology

GENERAL SUMMARY

SAGE Therapeutics is seeking a seasoned Toxicologist to lead our toxicology and safety pharmacology studies for non-clinical R&D.  Reporting to the Chief Scientific Officer, the successful candidate will be expected to participate on multidisciplinary drug discovery teams, where their role will be to plan, conduct and interpret non-clinical toxicology and Safety Assessment studies.

ESSENTIAL JOB FUNCTIONS

 

  • Develop strategy for  the non-clinical toxicology and Safety Assessment studies in  support of clinical development
  • Manage toxicology and safety pharmacology studies for compounds in various stages of research and development
  • Identify CROs for studies, oversee protocol design and serve as Study Monitor, (single/repeat dose toxicity, DART, genotoxicity, carcinogenicity studies, etc.)
  • Visit CRO sites to review facilities and capabilities of potential toxicology and safety pharmacology collaborators
  • Serve as the point on all Toxicology and safety pharm issues; identify and perform due diligence on external Sage consultants including coordination of all activities of externded Sage Toxicology and Safety pharm team
  • Negotiate budgets with CRO’s; ensure their timely conduct and delivery of reports
  • Prepare regulatory submissions and maintain regulatory submissions (annual reports, IBs, INDs and CTA’s)  
  • Aid in the preparation of responses to inquiries from regulatory agencies, Investigator's Brochure, nonclinical Pharmacology and Safety Assessment sections of INDs,  CTA's and/or NDAs
  • Participate on multidisciplinary drug discovery teams

COMPETENCIES

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.  Must excel in a multidisciplinary environment as an integral leader and team member across several project teams.  Excellent problem solving ability and attention to detail are critical.   Demonstrated ability to translate strategy into action while employing strong consensus-building skills.  Ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.

PREPARATION, KNOWLEDGE, SKILLS & ABILITIES 

 

  • PhD in a scientific discipline or DVM and a minimum of 7 years relevant experience. Board certification (DABT or DABVT ) preferred
  • Experience working on small molecule pharmaceutical drug candidates required
  • Experience with the development of CNS candidates highly preferred
  • Ability to communicate clearly and effectively with Management and CRO’s
  • An in-depth understanding of all aspects of pharmacology/toxicology with special emphasis on their application in drug discovery and the ability to work in a team-based drug discovery/development environment
  • Strong reasoning ability in the identification of problems and the ability to draw conclusions and make responsible decisions
  • The ability to utilize and/or develop connections within the scientific community and utilize these resources in the resolution of issues
  • The ability to work in a matrix environment with cross-functional teams
  • Understanding of current existing guidelines, regulations, requirements and standards (GLP, ISO, OECD, ICH)

 

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Director, Translational Neuroscience

SAGE Therapeutics is seeking an innovative, collaborative, and entrepreneurial neuroscientist to lead our Translational Neuroscience research efforts. We seek a scientist with strong in vivo preclinical biology expertise and the ability to integrate across core complementary technical disciplines, e.g., behavior, systems biology and neurophysiology, genomics etc. Experience with clinical aspects of translational biology and biomarker research is highly desirable.

The Director of Translational Neuroscience will be expected to design translational plans for Sage programs, as well as to conceive specific experiments to validate those plans.  The candidate will select vendors to conduct preclinical and/or clinical translational studies, oversee experiments, interpret results, and present results in context for project teams.  The ideal candidate will also provide strategic and operational leadership for a key discovery project team within our portfolio.

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 organization, academia and nonprofit organizations.

ESSENTIAL JOB FUNCTIONS*

  • Provide strategic and operational leadership for a key discovery project team within our portfolio.
  • Apply strong in vitro biology expertise and integrate across core complementary technical disciplines including behavior, systems biology and neurophysiology, genomics, etc.
  • Other duties as needed.

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

  • Ph.D. in Neuroscience/Neuropharmacology or related fields with 10-15 yrs. experience after postdoctoral training in pharmaceutical and/or biotech environment.
  • Relevant drug discovery/development experience in the pharmaceutical industry, with a strong track record of scientific innovation and success in delivering clinical candidates.
  • Demonstrated expertise as a project leader in Discovery and/or Clinical Development setting.
  • Multidisciplinary in vivo pharmacologist/systems biologist with behavioral expertise as well as other complementary technical experience, such as electrophysiology, genomics, neurochemistry, neuroanatomy etc.
  • Demonstrated experience and understanding in translational/biomarker research with a bench to clinic mind-set is very important (biomarkers include, EEG, genomics, plasma markers, various imaging modalities).
  • Sage Therapeutics is a wholly virtual biotech company. The ideal candidate must have the passion and ability to forge and nurture key partnerships and collaborations with the external scientific community, including academia, nonprofit organizations and CROs.
  • Demonstrated strong scientific reputation as evidence by good publication record

                                                                                                                                    

STAFF ACCOUNTANT

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.