QUALIFICATIONS

Required:

• Bachelor of Science in Engineering or Life Science
• Minimum 8 years of experience in a regulated industry, preferably at least 5 years in medical devices, pharmaceuticals, and/or combination products
• Minimum 3 years of experience in product development activities/process
• Minimum 3 years of experience leading cross-functional, matrixed teams; experience managing external customers/clients preferred
• Minimum 3 years of experience directly managing resources, budget, milestones, and detailed activities for large-scale projects
• Experience managing people directly
• 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 directly managing customers, partnerships, alliances, or external contracts
• Experience in additional functional areas (e.g., quality, regulatory, human factors, engineering, manufacturing, or strategic marketing)
• Master of Business Administration (MBA) or Master of Science in Engineering/Life Science
• Project Management (e.g., PMP, CAPM, CPMP, or Project Director) Certification

Skills & Competencies:

• Leads cross-functional team, including driving accountability and responsibility for results and forward progress
• Collaborates effectively with diverse stakeholders, including ability to facilitate/translate perspectives into group consensus; models 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
• Designs, 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:

• Manage drug partner program(s) and project(s) from inception through commercial launch and life-cycle management (i.e., product retirement); develop, track, analyze and communicate key performance indicators on the program, including the effectiveness of technical strategies, regulatory pathways, clinical build progress, project execution, and product development risks (e.g., alignment to schedule, scope, resources)
• Support all phases of the product development process from Concept to Launch; understand Design Control principles and support gate-keeping, design freezes, design reviews, change control, sign-offs, etc.
• Identify and implement best practices on programs; ensure consistency and thoroughness of deliverables throughout program
• Develop, maintain, and nurture positive relationships with key stakeholders at pharmaceutical partners; serve as ambassador for program; inspire confidence with pharma partner
• Develop, maintain, and nurture positive relationships with internal colleagues; demonstrate high level of interpersonal skills in interactions; work autonomously and exercise good judgement
• Maximize 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; facilitate change within the organization; model a culture of quality and continuous improvement
• Maintain awareness of new and changing processes on programs/projects; identify potential risks for pharmaceutical partners; implement necessary changes to maintain compliance
• Embody Enable values
• Foster teamwork, diversity, and inclusion within team, between teams and other groups