Director, Clinical Affairs.

novabio; Waltham (MA); Hybrid; USD 184,000 - 235,000; Full time

Benefits offered by this job

Hybrid work arrangements

Medical, dental, and vision coverage

401(k) company match

Bonus program

Tuition reimbursement

Professional development

Job summary

Nova Biomedical is seeking a Director of Clinical Affairs to lead clinical strategy, planning, and evidence generation for in vitro diagnostic and point-of-care products. This role oversees trials, post-market activities, and regulatory submissions to ensure timelines, budgets, and quality standards are met.

The successful candidate will manage site selection, study execution, and cross-functional collaboration with R&D, Quality, Manufacturing, and Regulatory teams, while advancing data

Qualifications

• 10–15+ years in the IVD sector
• Experience with point-of-care and critical care tech
• Experience managing or performing clinical trials
• Experience preparing scientific publications and presenting at conferences
• Experience developing and managing Key Opinion Leader relationships
• Familiarity with ISO 14155, ISO 20196, or ICH E6

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 to support efficiency and data integrity
• Represent Clinical Affairs in leadership discussions and provide updates, risk assessments, and recommendations

Skills

Clinical affairs leadership

Clinical trials management

Regulatory compliance

KOL relationships

Scientific publications

ISO/ICH knowledge

Cross-functional collaboration

Job description

Nova Biomedical: One Global Brand. One Vision. Together under one name.

Advanced Instruments and Nova Biomedical are now united under one brand, Nova Biomedical, marking a major milestone in our journey to deliver greater value to our customers. By combining our strengths, we’re accelerating innovation, supporting critical workflows, and delivering world-class service across the biopharmaceutical and clinical markets.

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.

About the Company

At Nova Biomedical, we’re not just building instruments, we’re powering breakthroughs that improve lives. Our smart, science-driven solutions are trusted in over 100 countries to speed drug development and enhance patient care.

Our integration brings together more than 70 years of scientific excellence with Nova’s cutting-edge innovation, forming a powerhouse of precision, purpose, and possibility. With FDA-registered, ISO-certified manufacturing, more than 125 FDA approvals, and industry-trusted diagnostics, we’re setting new standards in quality and reliability. Nova Biomedical is proud to be a global leader in osmolality testing and biotechnology and in vitro diagnostic (IVD) instrumentation, dedicated to advancing patient care and scientific discovery with a legacy that continues to shape the future of life sciences.

With headquarters in Norwood and Waltham, Massachusetts, and a global team of nearly 2,000 employees, we’re building a collaborative, empowered culture grounded in shared values: Customer Centricity, Ingenuity, Ownership & Accountability, Collaboration, and Integrity.

Working at Nova Biomedical means joining a mission-driven organization where your contributions matter.

Explore what’s next with us at novabiomedical.com

EEO Statement:

Nova Biomedical takes pride in being an equal opportunity employer committed to hiring a diverse and inclusive workforce. As a part of our commitment to a diverse and inclusive workforce, Nova Biomedical will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.

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