Job Summary: The Director, Clinical Affairs leads the Clinical Affairs function for in vitro diagnostic and point-of-care products, with responsibility for clinical strategy, study planning, execution, and clinical evidence generation. Oversees clinical performance studies and post-market activities supporting regulatory submissions, product development, and lifecycle management while ensuring compliance with regulatory requirements, timelines, budgets, and quality standards.
Responsibilities: - Develop and lead clinical affairs strategy aligned with product development, regulatory, and post-market evidence needs
- Lead clinical study design, planning, execution, monitoring, and reporting including timelines, budgets, and risks
- Develop, review, and approve clinical study documentation including protocols, reports, and regulatory support materials
- Oversee clinical site selection, start-up, conduct, and close-out ensuring data quality and compliance
- Ensure studies comply with applicable regulations, standards, and internal procedures
- Manage Clinical Affairs personnel, external partners, and vendors while supporting team development
- Partner with Regulatory Affairs to support submissions and clinical evidence requirements
- Collaborate cross-functionally with R&D, Quality, Manufacturing, Medical/Scientific, and Marketing
- Improve clinical processes, metrics, and governance practices to support efficiency and data integrity
- Represent Clinical Affairs in leadership discussions and provide updates, risk assessments, and recommendations
Experience Requirements: - 10• 15+ years of experience in the IVD sector
- Experience with point-of-care and critical care technologies
- Experience managing or performing clinical trials and evaluations
- Experience preparing scientific publications and presenting at conferences or seminars
- Experience developing and managing Key Opinion Leader relationships
- Familiarity with international clinical standards and regulations including ISO 14155, ISO 20196, or ICH E6
Physical Requirements and Working Conditions: - Comfort with working at a computer for extended periods.
- Capacity to lift and carry up to [25• 50] pounds as required
- Able to communicate effectively via phone, video, and written communication.
- Occasional need to move about the office to access meetings or resources.
Why Work for Nova Biomedical - Flexible Medical, Dental, & Vision Coverage
- Competitive 401k company match
- Bonus Program, Generous PTO and paid holidays
- Generous Tuition reimbursement
- Hybrid and flexible work arrangements
- Professional development, engagement and events
- Company marketplace for lunch and snacks in our Norwood, MA, Billerica, MA and Westbrook, ME offices
- Company subsidized cafeteria in our Waltham, MA office
Work Location: Waltham, MA work schedule on-site in Waltham, MA, 3• 5 days/week on-site/remote
Targeted Salary Range: $184,000-$235,000
Nova Biomedical believes in transparency and integrity throughout all we do, including compensation. The provided salary range for this role represents the expected base salary or hourly rate for this opening. Actual compensation will be commensurate with the candidate's experience and may vary based on individual factors such as location, skills, and education.
