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Sage Therapeutics Senior Manager, Clinical Operations in Cambridge, Massachusetts

General Scope and Summary

Sage Therapeutics is searching for a creative, resourceful, integrative thinker for an important role overseeing clinical development programs (pre-IND through Phase 1-4 clinical trials) in the field of neurology and CNS disorders. The Senior Manager, Clinical Operations and Development will manage, plan, and execute clinical studies, including creating and managing study timelines, budgets, and study management plans in a fully outsourced model. Additionally, this individual will provide guidance and shared learning within and across teams throughout planning and implementation, as well as ensure clinical operational and development deliverables and timelines are met across the development program(s). This position will report to the Director, Clinical Operations and Development.

Roles and Responsibilities

  • Manage all aspects of one or more clinical studies, including the study team and all external vendors; provide oversight and guidance to internal Clinical Operations team.

  • Manage direct reports, commensurate with experience.

  • Support the delivery of one or more programs independently.

  • Independently drive process and implement global Clin Ops strategy.

  • Maintain expert knowledge of Clinical Development programs. Can independently interpret data and make recommendation on next steps.

  • Liaise with clinical site staff and Investigators as appropriate to ensure optimal Sponsor-site relationships.

  • Develop and ensure execution of activities outlined in various study plans (sponsor oversight, monitoring, deviation, training, and study communication plans).

  • Co-monitor or monitor studies if needed for the program.

  • Drive communication and escalate issues to Clinical Operations Program Lead and, as appropriate, Clinical Sub Team.

  • Navigate team structure (SMT, CST, PT) and decision makers to independently resolve issues and escalate challenges/obstacles effectively.

  • Participate in preparation of regulatory filings (e.g. IND, pre-IND, orphan applications, etc.) as needed.

  • Manage CRO and other vendors.

  • Collaborate with CRO PM.

  • Study budget management, ensuring actuals are in line with forecast; be accountable for invoice approval.

  • Assist in long range budget planning, reforecasting, and resourcing.

  • Support and lead Study Team Management.

  • Lead cross-functional teams, pro-actively shaping team dynamics to support collaboration and accountability.

  • Collaborate with Medical Writing and Medical Science to lead protocol development.

  • Oversee performance, manage, and serve as point of contact for all CROs and vendors.

  • Manage vendor scope and budgets in alignment with study (program) budget.

  • Manage study resources, internally and externally, to optimize performance to study deliverables. Demonstrate ability to mitigate and escalate changes in scope appropriately.

  • Create and manage standardized clinical trial tools, processes, and SOPs.

  • Be accountable for clinical trial enrollment and risk mitigations.

  • Assist with other duties as assigned.

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, and good conflict management and negotiation skills. Must have a demonstrated ability to identify and analyze complex issues to develop relevant and realistic plans, programs, and recommendations and the ability to translate strategy into action. Must have excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.

Basic Qualifications

  • BS/BA required.

  • 6+ years of pharmaceutical or biotechnology industry experience.

Preferred Qualifications

  • Master’s degree or above preferred.

  • 3+ years of direct study management work preferred.

  • Extensive experience managing complex clinical programs, CROs, multiple vendors, budgets, and timelines.

  • Experience monitoring clinical studies and conducting PSVs, SIVs, IMVs, and COVs.

  • Thorough understanding of GCP and ICH regulations, clinical trial monitoring, and regulatory compliance.

  • Understanding of drug development from pre-IND through NDA.

  • Demonstrated effectiveness in resolving site management issues of varying complexity.

  • Protocol, ICF, and CSR writing experience.

  • Strong working knowledge of MS Project and developing Gantt charts.

  • Excellent oral, written, and medical communication skills.

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

  • A detailed understanding of overall strategic direction, interrelationships, and business needs.

  • Proven experience in the oversight of the operational aspects of all stages of clinical studies.

  • Ability to organize and manage multiple priorities.

  • Ability to build strong relationships with coworkers of various backgrounds and expertise.

  • Ability to function at a high level in a team setting, whether leading the group or acting as an individual contributor.

  • Experience in CNS/neurology preferred.

  • Proactive and positive management approach.

  • Maximum flexibility to adapt to changing program needs in real time.

  • Strong leadership skills and self-awareness.

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

  • 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.

Employment Type:

Employee

Number of Openings:

1

Job ID:

R001433

#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.

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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.

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