General Scope and Summary
SAGE Therapeutics is searching for a creative, resourceful, integrative thinker for an important role that is responsible for operational management of multiple workstreams across the Experimental Medicine Function (EXM). This key role will work to establish a robust project management infrastructure that EXM will use to design, conduct, and interpret results from a series of clinical trials intended to enhance the value of Sage Development programs. This role will also lead cross functional EXM teams to define the optimal strategy and will be a key partner for drug development teams. Additionally, s/he will drive the success of the experimental medicine group through a collaborative, energetic, flexible, thorough, and responsive work environment. The candidate will play a key role in day-to-day operations and long-range planning and will likely represent EXM in the existing operating model.
Develop overall strategic EXM department plan in conjunction with the CRO and EXM team.
Initiate and manage highly collaborative cross-functional relationships with Sage R&D functions in support of EXM projects.
Design and implement project management infrastructure in EXM to support project execution covering reporting, project planning, documentation workflow, budgeting, and risk management.
Be a proactive and primary voice for monitoring and reporting of project issues, plans, budgets and resources, including risks and mitigation plans.
Proactively plan with Scientific Leaders to put in place all elements of project plans and all components for each assigned EXM project.
Establish and monitor project goals as well as go/no go criteria for all key decision points
Lead cross-functional meetings, including the creation and distribution of meeting agendas and minutes, and drive completion of action items. Ensure good meeting disciplines are continuously maintained (with supporting documentation) so that there is a clear logical record of events for each project or partnership.
Develop and maintain project infrastructure – including library/repositories of data & actions, project Gantt Charts, and Budgets. Ensure data integrity to support accurate reporting and communications. Track progress against project plans and ensures project teams/stakeholders have the tools necessary to deliver assays/contracts/decisions and any other information needed.
Ensure smooth cross-functionally liaisons with critical functions for project success. Be accountable for good budgetary disciplines and adherence to contractual commitments.
Logical thinker with preference for analysis to support decisions and a good process orientation.
Results focused with ability to focus upon bigger picture/departmental objectives
Significant depth in early project management (IND-enabling through POC); additional late stage clinical development experience desirable
Strong understanding of inter-dependencies between disciplines in drug development; demonstrated knowledge of several allied disciplines, such as DMPK, pharmacology, toxicology, regulatory, clinical development, CMC
Strong interpersonal skills and the ability to motivate others, to direct activity from a position of informal influence, to negotiate conflict situations, and to forge consensus between competing points of view
Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient.
Demonstrated ability to translate strategy into action; ability to analyze issues to develop realistic and measurable plans, and to anticipate risk.
Excellent interpersonal skills, ability to develop important relationships with key stakeholders, strong conflict management and negotiation skills.
Superior communication, project management, and organizational skills.
Experience, Education and Specialized Knowledge and Skills
Master’s degree in a scientific or healthcare discipline preferred.
Minimum of 10 years of experience within the biotech/pharmaceutical industry in a role requiring an understanding of drug development.
Ability to organize and manage multiple priorities required.
Ability to implement structure without impacting efficiency of team
Confident communicator, utilizing tact and diplomacy up/down hierarchy and across matrix. Takes initiative to resolve problems rapidly.
Robust understanding of team dynamics, with strong team leadership ability.
Comfort with ambiguity; flexible and able to assimilate new knowledge and standards quickly.
Strong project management, problem-solving, decision-making and facilitation skills.
Experience in interfacing with and managing cross-functional teams.
Fluid use of MS Project, Excel, PowerPoint, and Outlook.
Demonstrated experience working in a matrix environment.
Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
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.