Senior Manager, Clinical Operations
General Scope and Summary
Sage Therapeutics is searching for a creative, resourceful, integrative thinker for an important role overseeing interventional clinical trial 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 out-sourced 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).
Roles and Responsibilities
Manage all aspects of multiple clinical studies, including the study team and all external vendors; provide oversight and guidance to internal Clinical Operations team.
Lead the evaluation, selection, and management of Contract Research Organizations (CROs) and other external vendors to ensure successful clinical trial implementation and execution.
Create, manage, and execute clinical operations programs, including study management, budget and forecasting timelines, and Gantt timeline creation.
Liaise with clinical site staff and Investigators as appropriate to ensure optimal Sponsor-site relationships.
Support the authoring of clinical study protocols, informed consent forms (ICFs), clinical study reports (CSRs), and other clinical documents as necessary.
Conduct monitoring oversight visits as needed for the program.
Develop and ensure execution of activities outlined in various study plans (data management, safety management, and study communication plans).
Participate in preparation of regulatory filings (e.g. IND, pre-IND, orphan applications, etc.) as needed.
Partner with CMC/clinical supplies to provide drug supply assumptions.
Manage all aspects of study progress from planning to close-out to assure adherence to intended timelines and achievement of study goals while ensuring quality in accordance with FDA, EMEA, GCP, and ICH guidelines.
Manage study budget, ensuring actuals are in line with forecast; be accountable for invoice approval.
Assist in long-range budget planning, reforecasting, and resourcing.
Drive communication and escalate issues to Clinical Operations Program Lead and, as appropriate, Clinical Sub-Team.
Navigate team structure (Study Management Team, Clinical Sub-Team, Project Team) and decision makers to independently resolve issues and escalate challenges/obstacles effectively.
Manage study resources, internally and externally, to optimize performance to study deliverables. Demonstrate ability to mitigate and escalate changes in scope appropriately.
Be accountable for clinical trial enrollment and risk mitigations.
Collaborate with Medical Writing and Medical Science to lead protocol development.
Lead Study Management Teams in support of clinical trial execution.
Lead, plan, and execute clinical Investigator meetings, study meetings, and vendor meetings as needed.
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, as well as 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.
5+ years of pharmaceutical or biotechnology industry experience; 3+ years of direct study management work.
Master’s degree or above preferred.
8+ years of pharmaceutical or biotechnology industry experience.
Line management experience preferred.
Experience in CNS/Neurology preferred.
Must have through understanding of GCP and ICH regulations, clinical trial monitoring, and regulatory compliance.
Understanding of drug development from pre-IND through NDA.
Extensive experience managing complex clinical programs, CROs, multiple vendors, budgets, and timelines required.
Experience monitoring clinical studies and conducting PSVs, SIVs, IMVs, and COVs required.
Demonstrated effectiveness in resolving site management issues of varying complexity.
Protocol, ICF, and CSR writing experience required.
Strong working knowledge of MS Project and developing Gantt charts is a plus.
Excellent oral, written, and medical communication skills required.
Experience working with all levels of management and consulting with key business stakeholders. An ability to build strong relationships and 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 while having the ability to multi-task fluctuating priorities.
Ability to lead cross-functional teams and proactively shape team dynamics to support collaboration and accountability.
Ability and willingness to travel up to 25% of the time, as needed.
Ability to function at a high level in a team setting, whether leading the group or acting as an individual contributor.
Proactive and positive management approach.
Maximum flexibility to adapt to changing program needs in real time.
Strong leadership skills and self-awareness.
Ability to build strong relationships with coworkers of various backgrounds and expertise.
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.
Number of Openings:1
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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.
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.
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.#LI-Remote