Director, Clinical Affairs.

Nova Biomedical Corporation; Waltham (MA); On-site; USD 184,000 - 235,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

401k match

PTO & holidays

Tuition reimbursement

Hybrid work

Job summary

Nova Biomedical in Waltham, MA is seeking a Director of Clinical Affairs to lead the clinical strategy for in vitro diagnostics and point-of-care products. You will oversee clinical studies, evidence generation, and post-market activities supporting regulatory submissions and product lifecycle.

You will manage a team and external partners, ensure compliance with ISO and ICH guidelines, and collaborate with R&D, Regulatory, Quality, Manufacturing, and Marketing to drive data integrity and timely

Qualifications

• 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.
• Experience developing and managing Key Opinion Leader relationships.
• Familiarity with ISO 14155, ISO 20196 or ICH E6 standards.

Responsibilities

• Develop and lead clinical affairs strategy aligned with product development and regulatory needs.
• Lead design, planning, execution, and reporting of clinical studies with timelines and budgets.
• Develop and approve study documentation including protocols and regulatory materials.
• Oversee site startup, conduct, and closeout ensuring data quality and compliance.
• Ensure studies comply with applicable regulations and internal procedures.
• Collaborate cross-functionally with R&D, Quality, Manufacturing, Medical, and Marketing.
• Represent Clinical Affairs in leadership discussions and provide risk assessments.

Skills

Clinical strategy

Study design

Regulatory support

KOL relationships

Cross-functional leadership

Quality governance

Job description

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 MedicalScientific 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

• 1015 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 2550 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 35 daysweek on siteremote

Targeted Salary Range

184000 235000

About the Company

At Nova Biomedical were not just building instruments were 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 Novas 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 were 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 2000 employees were 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 Whether youre in engineering science manufacturing or support youll be part of a team that values innovation invests in your growth and is committed to making a real world impact on global health Explore whats next with us at novabiomedicalcom

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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