SQZ Biotechnologies is seeking a Program Manager, Associate Director/Director to join our Clinical team. This is a new role reporting directly to the Chief Medical Officer. As the sole Program Manager at SQZ, you will be responsible for working across Research, Development, and Clinical to enable the successful delivery of SQZ’s cell therapy programs. In collaboration with the CMO, this individual will be responsible for leading cross-functional internal teams in accordance with the program strategy in all phases of development, such as lifecycle management, CMC project management, regulatory submissions and sub-projects within a major program. The successful candidate will be able to drive teams to achieve clarity on potential issues and focus on effective contingencies; manage external partners/collaborators; interface with senior management and influence decision-making on projects.
At SQZ, we're proud of our culture and always look to grow our team with people who share our values. We:
- Squeeze Together: We value teamwork, trust, and transparency as critical components for achieving our mission and exceeding our goals
- Question Boundaries: We’re committed to questioning the status quo and changing the world through our people and our science
- Zap Obstacles: We strive to be pioneers. We’re resilient when it comes to navigating challenges, anticipated or not, scientific and otherwise
Key Responsibilities: The scope of responsibilities extends from pre-clinical development through clinical regulatory submission.
- Accountable for program deliverables and timelines extending from pre-clinical development to clinical regulatory submission
- Manages operational activities (pre-clinical, CMC, regulatory, etc) and drives team performance to ensure successful and timely execution of established strategy
- Manages external partner/consultant interactions including contracts and tactical activities
- Leads the planning efforts for assigned development programs in defining and implementation of the Program Team strategy and operational plans
- Maintains and manages the operational plan and formulates the project scope, project plan, critical paths and risk-mitigation strategies with the Program Team and the Senior Management team
- Identifies and drives program and resource priorities that align with the business objectives and identifies ways to accelerate execution where possible while maintaining high quality standards
- Identifies and escalates potential risks/obstacles and sees through to resolution ensuring that all issues arrive at a singular conclusion or recommendation
- Establishes, communicates, integrates and executes plans that drive toward the achievement of company goals
- Generates collaboration, cooperation and communication across cross-functional teams to achieve stated goals
- Responsible for setting and managing expectations, highlighting and proactively resolving issues, ensuring regular communications and managing internal and external activities
- Facilitates the system to track and monitor program objectives/goals
- Bachelor’s degree and a minimum of 7 years’ experience as a program manager leading complex projects in a multi-disciplinary, global environment. Master’s, Ph.D., PharmD or MBA a plus
- Extensive drug development experience with drugs in Phase I-III
- Experience in the life sciences/Biotech/Pharmaceutical industry
- Proven leadership experience managing cross-functional teams with demonstrated skills in strategic planning, risk mitigation, and problem-solving
- Solid working knowledge of functional BLA and NDA components/requirements required
- Excellent verbal, written, and organizational communication skills
- Strong interpersonal skills with the ability to motivate others, influence without authority and develop important relationships with key stakeholders
- Ability to drive decision-making within cross-functional teams
- Proficient in Microsoft Office including Word, Excel, PowerPoint, Project or Visio
- Ideal candidate has worked on a program(s) that lead to successful regulatory approval (i.e., NDA, BLA, MAA)
- Experience in immunology and/or cell therapy is a plus.
- Successful track record of improving business relationships using key performance metrics, excellent project management skills and effective management of key supplier relationships to achieve outsourcing excellence
- Professional Certification preferred (CPM, C.P.S.M.)
SQZ Biotechnologies is proud to be an equal opportunity employer and to provide equal opportunities to all employees and applicants for employment without regard to race, color, religion, sex or gender identity, national origin, age, disability, sexual orientation or genetics. In addition to federal law requirements, SQZ complies with applicable state and local laws governing nondiscrimination in employment.
Local candidates only please.
Location/Region: Watertown, MA