General Scope and Summary
SAGE Therapeutics is searching for a creative, resourceful, integrative thinker to oversee two or more high priority neuroscience development programs as they transition from research through clinical development. The ideal candidate will possess demonstrated program experience, initally leading early stage drug development programs, working with experimental medicine, pharmacology, or similar research functions. The Program Leader will be responsible for leading and managing novel drug development projects and teams to successful development, NDA submission and market introduction. This individual will work closely with all levels of leadership to determine program strategies and with internal and external groups to resource and implement all aspects of a drug development project. The Program Leader will set strategies and implement operating plans for the organization and be responsible for the overall project budget.
Roles and Responsibilities
- Lead drug development program(s), focused development and delivery of novel medicines to patients as expeditiously as possible, providing a model for effective team leadership within a matrix environment.
- Ability to identify and develop common ground on matters of strategic importance and communicate effectively among a wide range of stakeholders internally and externally.
- Develop, prioritize, document and communicate measurable annual and long-range plans.
- Work closely with Medical Sciences, Regulatory Affairs, and Commercial to set team strategies through the Development Team.
- Work with the relevant functions to identity key development and commercialization issues, develop plans to support market introduction, and proactively develop plans to support life-cycle management.
- Responsible for the management and delivery of an integrated development plan for the compound(s) and ensuring alignment across strategic, operational and tactical plans.
- Drives decision point planning and associated deliverables across all functions of the team Ensures the input from sub-teams to support the advancement of the program’s objectives and deliverables.
- Assure that management is appraised, in a timely fashion, of the current status and issues surrounding each project.
- Provide effective solutions for solving Program Team conflicts.
- Manage the program through effective budget planning and accountability, objective setting, performance appraisal and individual development, as appropriate.
- Review and allocate resources in collaboration with functional areas and program teams
- Provide sound strategic thinking related to regulatory interactions that lead to successful outcomes; attend key meetings with regulatory agency, as applicable.
- Define and articulate clear strategic vision within program teams, serving as visible program champion and focal point for critical program information.
- Establish and maintain integrated cross-project plans to enable accurate project, financial and portfolio analyses and ensure accurate information is provided for planning processes and resource allocation.
Experience, Education and Specialized Knowledge and Skills
Must thrive working in a fast-paced innovative environment while remaining flexible, proactive, resourceful and efficient. Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations. 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 and mitigate risks.
- Advanced degree in life sciences; a PhD or MBA is a plus.
- Advanced degree and 15+ years of multi-disciplinary experience in the biotech/pharmaceutical industry with 8+ years of direct project/program leadership experience, leading a cross-functional team in a matrix environment.
- Have a past record of achievement in leading and managing project teams and product development with a thorough understanding of the drug development process at a strategic level through the entire lifecycle.
- Ability to resolve ambiguity, remove barriers and act decisively to provide clarity.
- This position requires an individual with outstanding organizational and interpersonal skills. It is essential that this individual have the ability to manage relationships and achieve results through influencing others in the organization.
- Highly developed negotiation skills.
- Strong knowledge of program budget process and resource allocation.
- Superior oral and written communication skills are required, as is the ability to function effectively with senior management.
- A strong focus toward creativity, independent thinking and results orientation is required.
- Leading programs toward successful NDA/ MAA submissions.
- Must have high ethical standards and impeccable integrity.
- Must have highly developed personal leadership style and confidence.
- Must be able to apply independent thinking, organizational abilities and strong discipline in a dynamic environment.
- Must have strong detail orientation and be hands-on when needed to do what it takes and achieve key objectives.
- Ability to understand stakeholder concerns and frame issues/proposals to influence decision-making.
- Advanced knowledge of FDA, EMA and ICH regulations, industry standards and quality control principles.
- Capable of managing multiple programs simultaneously with a focus on issue identification, escalation and resolution.
- Demonstrate and apply understanding of the interdependencies between various stakeholders within the drug development process including but not limited to: medical, science, clinical operations, manufacturing, business, legal & regulatory to accelerate overall drug-development program.
- Demonstrated technical proficiency, scientific creativity, independent thought and ability to effectively collaborate with others.
- Skilled at diplomacy and relationship building with the leadership team as well as the functional leads with the foresight and savvy to drive programs to support the corporate goals.
- 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.
- Attention to detail and the ability to work individually, within a multi-disciplinary team in a matrix environment, 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