Senior Project Manager, Clinical Development

General Scope and Summary 

SAGE Therapeutics is searching for a creative, resourceful, integrative thinker to play a critical cross-functional role within Clinical Development. This role requires strategic thinking and the ability to lead and drive change. This individual establishes, tracks, monitors, and reports performance metrics and project status and develops communication processes and standards of operating to drive program progress. This role is responsible for coordinating Clinical Development business objectives and ensuring alignment with SAGE standards and long-term business goals.
 

Roles and Responsibilities

• Facilitate effective decision-making within committee meetings by developing clear agendas, targeting meeting materials to track issues/actions/decisions, and helping the team identify project risks, understand their impact, and implement mitigation strategies.

• Work across Clinical Development to establish productive cross-functional relationships that are key to decision-making within teams.

• Collaborate cross-functionally to monitor program metrics and KPIs and translate their impact to teams.

• Independently initiate process development and standards of operating to drive program progress and lead change management for endorsement and consistent adoption across programs.

• Serve as a communication champion and conduit for linking Clinical Development functions and facilitating organizational information sharing.

• Identify new projects to support the conduct and growth of Sage Clinical Development and assist in the prioritization and resourcing of projects.

• Support functional leaders in operational build activities/infrastructure development and resource planning.

• Drive innovation and lead the delivery of continuous process improvement.

• Plan and own activities while leading others to meet all short/long term objectives and resolving competing priorities.

• Promote and contribute to the ongoing development of program and project management best practices.

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 the ability to analyze issues to develop realistic and measurable plans and to anticipate risk. Must have the ability to build sustainable relationships with other team members and to create/promote an effective working environment for the team. Excellent communication and project management skills and a high level of organizational skills are critical.

Basic Qualifications

• Bachelor’s degree required.

• 5+ years of experience in a biotech/pharmaceutical role and 2+ years of experience in a role in clinical development, clinical operations, and/or study management.

Preferred Qualifications

• Master’s degree in a scientific or healthcare discipline preferred.

• Project Management experience, including a strong working knowledge of MS Project and facility with developing Gantt charts.

• Relevant experience in R&D and clinical development processes.

• Proven track record in leading multi-functional teams and stakeholder management, working with all levels of management, and the ability to lead through influence in order to drive team projects forward.

• Possesses detailed knowledge of Good Clinical Practice (GCP) and regulations governing clinical research.

• Demonstrated experience with major regulatory submissions (NDA, BLA, MAA) is a plus.

• Fluency with use of MS Project, Excel, PowerPoint, and Outlook.

• In-depth attention to detail and the ability to work individually, within a multi-disciplinary team and matrix environment, as well as with external partners and vendors.

• Excellent verbal and written communication skills are a must. Demonstrated skills in networking internally and externally and communicating with various stakeholders, requiring tact and diplomacy.

• Embrace our Core Values: Put People First, Improve Lives, Cultivate Curiosity, Do Right, and Forge New Pathways.

• Excitement about the vision, mission, and therapeutic focus 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.

EEO is the 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.