Sr. Manager/Assoc. Director, Clinical Project Management
Harpoon Therapeutics (ticker: HARP) is a clinical-stage immunotherapy company developing a novel class of T cell engagers that harness the power of the body’s immune system to treat patients suffering from cancer and other diseases. T cell engagers are engineered proteins that direct a patient’s own T cells to kill target cells that express specific proteins, or antigens, carried by the target cells. Using its proprietary Tri-specific T cell Activating Construct (TriTAC®) platform, Harpoon is developing a pipeline of novel TriTACs initially focused on the treatment of solid tumors and hematologic malignancies. HPN424 targets PSMA and is in a Phase 1/2a trial for metastatic castration-resistant prostate cancer. HPN536 targets mesothelin and is in a Phase 1/2a trial for cancers expressing mesothelin, initially focused on ovarian and pancreatic cancers. HPN217 targets BCMA and is in a Phase 1/2 trial for relapsed, refractory multiple myeloma. HPN328 targets DLL3 and is in a Phase 1/2 trial for cancers expressing DLL3, initially focused on small cell lung cancer and other tumors with high-grade neuroendocrine features. Harpoon is led by an experienced management team. The company emphasizes a collegial, collaborative environment and has a strong record of scientific innovation, pioneering protein engineering, expertise in tumor immunology and pre-clinical and clinical research. For additional information about Harpoon Therapeutics, please visit www.harpoontx.com.
You will be responsible for providing Program/Project Management expertise and support to Harpoon programs to ensure all Program/Project milestones and deliverables are met, and that tasks are well executed and managed. Your responsibilities include partnering with the Program Leader to create the program plan and budget, as well as day-to-day planning, coordinating and tracking of critical activities. You will also be responsible for driving the program timelines to keep the program on schedule and within budget. Additional responsibilities, as highlighted in more detail below, also include planning, facilitating, and following-up on regular product team meetings; anticipating and managing potential program issues; understanding the scope, schedule and resources for the program; utilization of Gantt charts and other project management tools to facilitate communication within the team, across the organization, and with external collaborators. In addition, you may be asked to lead and/or participate in special department, cross-functional, or team projects.
- Serve as Project Manager for one or more complex, cross-functional Product Development Teams that include representatives from Clinical, Clinical Operations, Non-clinical, Regulatory, CMC and Business Intelligence
- Partner with the Program Team Lead to optimize team effectiveness and decision making. Works with the Program Team Lead and Product Development Team to develop a detailed project plan and associated budget ensuring cross-functional alignment and accountability
- Create and drive timelines to keep program(s) on schedule. Prepare program timelines (Gantt chart) identify all significant activities, dependencies, resources and milestones. Assist the Program Team Lead in planning, coordinating and tracking cross-functional and external activities for the Harpoon program. Continual review and analysis of critical path activities.
- Drive planning for key drug development stage-gate decision points (e.g., First in Human, End of Phase 2, Filing, and Launch)
- Facilitate highly effective team building and communication. Work with the Program Team Lead and Product Development Team to develop and distribute agendas for regular team meetings. Provide meeting minutes and drives follow up on Action Items. Proactively, and independently, identify and resolve Product Development/Study Execution Team challenges
- Perform effective risk management assessments with the Product Development Team, the Program Team Lead, and stakeholders.
- Prepare information with appropriate input from Product Development Team members for internal as well as external partner review/governance meetings.
- Drive information flow and communicates program status to all stakeholders in collaboration with the Program Team Lead. Produces regular status reports (milestones, status, issues, decisions), following review by the Program Team Lead and Product Development Team, for senior management.
- Manage the annual budgeting and long-range planning process
- Identifies, develops and/or maintains an appropriate electronic platform (SharePoint, Shared Folders, etc.) for reporting/archiving/documentation of relevant program information, records, etc.
- Creates and maintains easily accessible, high level program documents in electronic format.
- Serve as a single point of contact for cross-functional Product Development Team information (content and quality)
- Communicate cross-functional project information at Product Development meetings and to other stakeholders, as appropriate
- Contribute expertise to the development and implementation of project management best practices to help further the needs of the business
Skills and QUALIFICATIONS
- At minimum, a bachelor's degree in nursing, science or health related field required
- At least 2 years of oncology experience preferred
- 5-8 years of project manager experience in drug development, clinical project management experience a must
- Project planning experience required, especially an understanding of the clinical development and product commercialization processes. PM Certification is a plus.
- Capable of assessing and updating detailed project timelines in meetings to guide and align study team members
- Ability to drive program plans and timelines (across multiple functional areas) is essential. Proven success in goal setting, prioritization and time management is required.
- Clinical research knowledge and cross-functional understanding of clinical trial methodology
- Ability to work independently in decision-making and resolution of program obstacles and conflicts.
- Familiarity with developing budgets and forecasting is desirable.
- Ability to evaluate meeting minutes and materials for required updates to project timelines
- Must display strong analytical and problem-solving skills.
- Excellent verbal and written communication, strong organizational and interpersonal skills
- Ability to work in a dynamic, fast-paced, timeline-based environment