Senior Manager, Clinical Operations & Development
General Scope and Summary
SAGE Therapeutics is searching for a creative, resourceful, integrative thinker for an important role overseeing all phases of clinical trials (pre-IND through Phase 1-4 clinical trials) in the field of neurology and CNS disorders contributing to the clinical development program. This key role will manage, plan, and execute clinical studies, including creating and managing study timelines, budgets, and study management plans in a full outsourced model. Additionally, this individual will provide guidance and shared learning with 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.
Roles and Responsibilities
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 as well as budget and Gantt timeline creation.
Liaise with clinical site staff and Investigators as appropriate to ensure optimal Sponsor-site relationships.
Author clinical study protocols, informed consent forms (ICFs), clinical study reports (CSRs), and other clinical documents as necessary.
Co-monitor or monitor studies if 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 and contribute to design and packaging of supplies for clinical trials.
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.
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, good conflict management and negotiation skills, and the ability to identify issues and raise to key stakeholders in order to develop relevant and realistic plans, programs, and recommendations. Must have a demonstrated ability to translate strategy into action, excellent analytical skills, and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.
Bachelors degree in a scientific or healthcare discipline and a minimum of 7+ years in clinical and drug development in the pharmaceutical/biotech industry.
Master's degree in a scientific or healthcare discipline.
At least 3 years of direct study management work.
Understanding of drug development from pre-IND through NDA.
Extensive experience managing clinical programs, CROs, budgets, and timelines required.
Strong working knowledge of MS Project and developing Gantt charts.
Excellent oral, written, and medical communication skills required.
Experience monitoring clinical studies and conducting PSVs, SIVs, IMVs, and COVs required.
Management of CROs, multiple vendors, and complex protocols.
Protocol, ICF, and CSR writing experience required.
A detailed understanding of overall strategic direction, interrelationships and business needs.
Experience in CNS/neurology preferred and experience with orphan indications will be favorably considered.
Proven experience in the oversight of the operational aspects of all stages of clinical studies.
Ability to organize and manage multiple priorities.
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 co-workers of various backgrounds and expertise.
Experience working with all levels of management and consulting with key business stakeholders. An ability to influence for greater outcomes.
Strong team player that has a customer service approach and is solution-oriented.
Embrace our Core Values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun.
Excitement about the vision and mission of Sage.
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.
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.