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The Program Manager position ensures business objectives are met within various Programs and Projects at Renegade. The Program Manager communicates goals, leads working teams while juggling multiple projects to ensure a program’s success. This is a role that is logical and creative, as well as instinctive and strategic.
This position is responsible for providing Program/ Project Management expertise and support across renegade.bio’s IVD medical devices throughout the product life cycle. The Program Manager is an integral contributor to the buildout of Renegade’s Program Management Organization. Responsibilities include partnering with Project Managers to establish and maintain integrated project schedules, as well as day-to-day planning, coordinating, and tracking of critical path activities. This role is responsible for driving timelines to keep programs on schedule and within budget. Additional responsibilities include facilitation of program team meetings, including preparation of status reports and specific project updates.; anticipating and managing potential program issues and mitigation measures; understanding the scope, schedule and resources for the program; utilization of Gantt charts and other project management tools to facilitate communication within the team, and across the organization.
Essential Duties and Responsibilities
The essential functions include, but are not limited to the following:
- Provides Program/Project Management expertise in order to meet business objectives by successfully designing, implementing and executing programs per regulatory requirements.
- Collaborates with cross-functional teams such as Research & Development, Lab Operations, Marketing, Legal, Finance, as well as Medical, Clinical, Quality and Regulatory Affairs, and other key stakeholders, to drive information flow and achieve deliverable targets and milestones.
- Contributes to the build-out and maintenance of the Program Management Organization, including templates, management tools, SOP’s, and tracking tools.
- Prepares program timelines identifying all significant activities, dependencies, resources and milestones.
- Plans, facilitates, and follows up on regular program team meetings; anticipates and manages potential program issues; understands the scope, schedule and resources for programs; utilizes Gantt charts and other project management tools to facilitate communication within the team, and across the organization.
- Develops, tracks, and analyzes key performance indicators (KPIs), including the effectiveness of technical strategies, regulatory pathways, clinical development progress, project execution, and product development risks (e.g., adherence to schedule, scope, resources).
- Oversees project managers and their project teams.
- Continually reviews and analyzes critical path activities. Creates fast, effective, and proactive mitigation measures.
- Contributes to best practices to program/ project management in order to ensure goals, objectives, and performance metrics are met; identifies new opportunities to streamline business processes.
- Partners with the Team Leads to optimize team effectiveness and decision making
- Performs effective risk management assessments with the Program Team, the Project Manager, and stakeholders
Minimum Qualifications (Knowledge, Skills, & Abilities)
- BA/BS in a scientific or business field required.
- 3+ years experience with a role in program or project management.
- PMP certification is a plus, but not required.
- Strong project and process management skills. Capable of working on multiple programs simultaneously across various functional areas.
- Excellent understanding of Program and Project management software (Asana preferred).
- Proven success in goal setting, prioritization, and time management. Can prioritize multiple tasks and goals to ensure they are on-time, on-target and within-budget.
- Knowledge of CLIA/CAP, FDA regulatory processes and design control. Experience with 510K, medical device and/or IVD submission preferred. ICH experience is a plus, but not required.
- An excellent communicator who can explain program goals to those in different roles and adjust jargon accordingly.
- An aptitude for scheduling and assigning tasks.
- Strong negotiation, interpersonal, and partnership skills: demonstrates some leadership skills, works well within teams, and is effective in collaborating with internal and external stakeholders.
- A visionary who is both creative and strategic.
- Note: All offers of employment are contingent upon clear results of a thorough criminal background check.
Physical Demands and Work Environment
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions. While performing the duties of this position, the employee is regularly required to talk or hear. The employee frequently is required to use hands or fingers, handle, or feel objects, tools or controls. The employee is occasionally required to stand; walk; sit; reach with hands and arms; climb or balance; and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, color vision, peripheral vision, and the ability to adjust focus. The noise level in the work environment is usually moderate.
Job Type: FT
Salary: $130K-$145K DOE
Benefits: Health, Vision, and Dental; 120 hours PTO; 401k