Company Overview
Immunome is a clinical-stage targeted oncology company committed to developing first- and best-in-class targeted therapies designed to improve outcomes for cancer patients. We are advancing an innovative portfolio of therapeutics, drawing on leadership that previously played key roles in the design, development, and commercialization of cutting-edge targeted cancer therapies, including antibody-drug conjugate therapies (ADCs.) In addition to a portfolio of discovery-stage ADCs, our pipeline includes AL102, a gamma secretase inhibitor which is currently in a Phase 3 trial for treatment of desmoid tumors, as well as IM-1021, a ROR1 ADC, and IM-3050, a FAP-targeted radioligand, both of which are the subject of INDs expected to be submitted in the first quarter of 2025.
Position Overview
The Director of Project Management for Late-Stage Programs will be integral in managing and advancing late-stage biotech programs through Phase 2 and Phase 3 clinical trials. The ideal candidate is a highly organized and experienced individual with a strong background in project management and late-stage drug development. This person will collaborate closely with clinical development teams, regulatory affairs, and other cross-functional departments to ensure the timely and successful progression of pipeline candidates. This position reports to the SVP of Project and Program Management and will also support additional internal projects as the company continues to grow.
Responsibilities
Program Management
- Lead the planning, execution, and monitoring of late-stage programs, from Phase 2 through Phase 3 clinical trials.
- Develop comprehensive project plans, including timelines, milestones, and resource allocation.
- Ensure programs are delivered on time, within scope, and within budget.
Team Coordination
- Coordinate cross-functional project teams, including clinical development, regulatory affairs, quality assurance, and external partners.
- Facilitate regular team meetings to track progress, address issues, and ensure alignment with program goals.
- Foster a collaborative and productive team environment.
Stakeholder Engagement
- Serve as the primary point of contact for internal and external stakeholders regarding program status and updates.
- Communicate program progress, challenges, and solutions to senior leadership and other stakeholders.
- Manage stakeholder expectations and resolve conflicts that may arise during program execution.
Risk Management
- Identify potential risks and develop mitigation strategies to ensure program success.
- Monitor and manage risks throughout the program lifecycle.
Budget and Resource Management
- Develop and manage program budgets, ensuring efficient use of resources.
- Monitor program expenses and adjust budgets as necessary.
- Secure and allocate resources, including personnel, equipment, and materials.
Documentation and Compliance
- Ensure all program documentation is complete, accurate, and compliant with regulatory requirements.
- Maintain detailed records of program activities, including progress reports, meeting minutes, and action items.
- Ensure programs adhere to industry standards and regulatory guidelines.
Additional Project Support
- Support additional internal projects as the company grows, providing project management expertise.
- Facilitate the successful execution of various initiatives, aligning with the company’s strategic goals.
Performance Monitoring and Reporting
- Develop and implement metrics to evaluate program performance.
- Prepare and present regular reports on program status, performance, and outcomes to senior leadership.
- Use data-driven insights to recommend strategic adjustments.
Qualifications
- PhD in Life Sciences (Biotechnology, Pharmacology, etc) recommended; other advanced degree (MBA, Master’s) with relevant experience will also be considered.
- Minimum of 10 years of experience in project management within the biotechnology or pharmaceutical industries, with a focus on late-stage programs.
- Proven leadership experience with the ability to lead cross-functional teams and manage complex projects.
- Strong interpersonal and communication skills, with the ability to influence and build relationships at all levels. Excellent problem-solving and decision-making abilities.
- Demonstrated ability to manage multiple priorities in a fast-paced environment.
Knowledge and Skills
- High proficiency in project management tools and software (e.g., MS Project, Asana, Trello).
- Extensive understanding of late-stage drug development processes and requirements.
- Knowledge with regulatory requirements and industry standards (e.g., FDA, EMA).
- Experience with data analysis and performance measurement techniques.
- High proficiency in MS Office Suite (Word, Excel, PowerPoint).
E/E/O
Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
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