Enable Injections, Inc. · 8 hours ago
Program Manager
Cincinnati Metro
Full-time
Onsite
Senior Level, Lead/Staff
8+ years expEnable Injections, Inc. is a company focused on drug delivery solutions, and they are seeking a Program Manager to oversee drug partner programs from inception through commercial launch. The role involves managing relationships with stakeholders, ensuring compliance with regulations, and supporting the product development process.
Health CareLife ScienceManufacturingMedical Device
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
Implement best practices on programs/projects; ensure consistency and thoroughness of deliverables throughout program
Develop, maintain, and nurture positive relationships with key stakeholders at pharmaceutical partners; serve as key contact for program; establish credibility with pharma partner
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 on programs/projects; identify potential risks for pharmaceutical partners; implement necessary changes to maintain compliance
Model teamwork, diversity, and inclusion within team, between teams and other groups
Qualification
Required
Bachelor of Science in 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
Experience in product or process development activities/process
Minimum 3 years of experience leading cross-functional, matrixed teams; experience managing external customers/clients preferred
Experience directly managing resources, budget, milestones, and detailed activities for large-scale projects
Experience managing people directly preferred
Experience directly managing customers, partnerships, alliances, or external contracts preferred
Experience in additional functional areas (e.g., quality, regulatory, human factors, manufacturing, or engineering) preferred
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
Manage integration across companies for co-sponsored projects
Master of Business Administration (MBA) or Master of Science in Engineering/Life Science (Preferred)
Project Management (e.g., PMP or CAPM) Certification (Preferred)
Knowledge of regulatory requirements governing drug and device development, human factors, commercial manufacturing operations, regulatory approvals and/or product launch experience
PMP or CPM
Company
Enable Injections, Inc.
Cincinnati-based Enable Injections is a global healthcare innovation company developing and manufacturing drug delivery systems designed to improve the patient experience.
201-500 employees
Funding
Current Stage
Growth StageTotal Funding
$352MKey Investors
SanofiMagnetar CapitalORI Capital
2026-01-06Corporate Round· $30M
2022-01-27Series C· $215M
2020-09-08Debt Financing· $25M
Leadership Team
Mike Hooven
President and CEO
Tim Flaherty
Vice President-Finance, Chief Financial Officer
Recent News
2026-01-22
vcnewsdaily.com
2026-01-07
Company data provided by crunchbase