SQZ Biotechnologies is seeking a pharmaceutical/biotechnology Associate Director/Director - Clinical Program Management, with solid experience in leading clinical programs from early stage clinical through product launch. This is a new role reporting directly to the Chief Medical Officer. As the sole Clinical Program Manager at SQZ you will be responsible for working across Research, Development, and Clinical to enable the successful implementation SQZ’s cell therapy programs at clinical sites. In collaboration with the CMO, this individual will be responsible for working cross functionally in accordance with the program strategy in all phases of clinical development, such as life cycle management, regulatory submissions and sub projects within a major clinical program. The successful candidate will be able to work with teams to achieve clarity on potential issues and focus on effective contingencies; manage external CROs/clinical 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
- The scope of responsibilities extends from pre-clinical development through clinical regulatory submission.
- Provides direction, strategy, and leadership of project planning efforts through successful execution of clinical studies
- Organizes translational and clinical sub-teams in defining and implementing clinical strategy
- Must be familiar with program scope and objectives, as well as the role and function of each team member, to effectively coordinate the activities of the clinical team and manage program information and communications to all stakeholders.
- Works closely with stakeholders to create and maintain timelines for each program and at all clinical sites
- Leads the planning efforts for assigned clinical development programs in defining and implementation of the strategy and operational plans
- Creates and maintains the clinical development plan and formulates the project scope, project plan, critical paths and risk-mitigation strategies with the Program Team and the Senior Management team
- Drives clinical programs 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
- 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 clinical program objectives/goals
Minimum Basic Qualifications:
- Requires a 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, PhD, PharmD or MBA a plus
- Extensive drug development experience with drugs in Phase I-III
- Previous extensive experience working within a fast-paced, clinical-stage pharma environment and managing planning, execution strategies, registration, and life cycle management is required. Solid working knowledge of functional BLA and NDA components/requirements required
- Willingness to take a hands-on, “roll up your sleeves” approach toward achieving business objectives and goals
- 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
- Proficient in Microsoft Office including Word, Excel, PowerPoint, Project or Visio
Preferred Qualifications and Experience:
- Ideal candidate has worked on a program(s) that lead to successful regulatory approval (i.e., NDA, BLA, MAA)
- Experience in 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.
Location/Region: Watertown, MA