Location: Onsite

Status Type: Full Time

QUALIFICATIONS

Required:

• Bachelor of Science in Business, Engineering, or Life Science
• Minimum 8 years of experience in a regulated industry, preferably at least 3 years in medical devices, pharmaceuticals, and/or combination products
• Minimum 3 years in commercial operations/sales operations or customer service; experience working directly with ERPs and/or CRMs with a minimum 2 years working with SAP
• Minimum 3 years of experience leading cross-functional, matrixed teams
• Experience directly managing resources, budget, milestones, and/or detailed activities for large-scale projects
• Experience directly managing customers, partnerships, alliances, or external contracts
• Experience in additional functional areas (e.g., supply chain, sales, marketing, manufacturing, or engineering)
• Experience working directly with ISO, FDA, MDD, and/or other healthcare industry regulations and standards
• Proficiency utilizing Microsoft Office suite (Word, Excel, PowerPoint, Project)

Preferred:

• Experience implementing commercial systems and processes at an early-stage enterprise
• Experience in product or process development activities/process
• Experience managing people directly
• Master of Business Administration (MBA) or Master of Science in Engineering/Life Science
• Project Management (e.g., PMP, CAPM, CPMP) Certification

Skills & Competencies:

• Leads cross-functional team, including driving accountability and responsibility for results and forward progress
• Collaborates effectively with diverse stakeholders; demonstrates partner commitment and customer orientation
• Communicates effectively in writing, including ability to write in a clear, concise, logical, and grammatically correct manner
• Seeks to understand when listening to others; demonstrates awareness of what is requested; communicates orally in a professional manner that inspires confidence
• Exercises discernment in dissemination of information and sense of urgency; escalates issues to ensure timely and relevant responses; demonstrates ability to handle sensitive information with discretion and tact
• Demonstrates high attention to detail; fosters a culture of excellence in partner deliverables
• Distills complicated topics for intended audience; facilitates large discussions, and adjusts/adapts/responds to real-time feedback
• Leads and executes strategic plans and workstreams, including planning, organizing, securing, and managing resources to achieve goals
• Solves problems, including providing clarity in defining problem statements in ambiguous, complex situations; draws logical conclusions
• Sets clear goals, delegates effectively, and leverages the skills and expertise of others
• Influences without direct authority and negotiates conflict; maintains rational and objective demeanor when faced with stressful situations

Physical Requirements:

• Ability to remain in stationary position for extended periods of time
• Ability to consistently operate a computer, and other office equipment (e.g., printer, telephone, etc.)
• Ability to work in an open office environment, on-site at an Enable location

RESPONSIBILITIES:

• Create a vision and roadmap for the foundational commercial systems (tools, reporting, dashboards) to support launch readiness; streamline commercial operations processes and ensure alignment with regulatory and quality requirements specific to combination products
• Coordinate and partner with program management, supply chain, manufacturing, and engineering to operationalize the commercial readiness roadmap
• Lead internal JMST (joint manufacturing supply team)
• Lead partner-facing JMSTs (joint manufacturing supply team)
• Develop and document standard operating procedures (SOPs) for commercial workflows, ensuring scalability and compliance
• Implement best practices on programs; ensure consistency and thoroughness of deliverables
• Develop, maintain, and nurture positive relationships with key stakeholders at pharmaceutical partners; inspire confidence with pharma partners
• Develop, maintain, and nurture positive relationships with internal colleagues; demonstrate high level of interpersonal skills in interactions; work independently with limited oversight
• Leverage team skills and experience to achieve program/project goals; communicate clear expectations to team members in order to meet deadlines
• Identify business and process issues; model a culture of quality and continuous improvement
• Maintain awareness of new and changing processes in commercial operations; identify potential risks for pharmaceutical partners; implement necessary changes to maintain compliance
• Model teamwork, diversity, and inclusion within team, between teams and other groups
• Operate effectively in a dynamic start-up environment; be willing to do tasks outside of immediate responsibilities to contribute to overall team success