Clinical Development Scientist

USDM Life Sciences; Cambridge (MA); Remote; USD 80,000 - 100,000; Full time

Job summary

An established industry player is seeking a Clinical Development Scientist to drive innovation in clinical research. This exciting role involves providing strategic guidance on clinical evidence, collaborating with diverse stakeholders, and leading initiatives that enhance product development. With a focus on regulatory compliance and evidence generation, you will play a pivotal role in transforming healthcare solutions. Join a dynamic team dedicated to improving patient outcomes through cutting-edge research and development, while benefiting from a supportive work environment and comprehensive benefits package.

Benefits

Health Insurance

Vision Insurance

Dental Insurance

401k

Paid Time Off

Recognition Programs

Qualifications

• 7+ years in clinical research/development with AI validation experience.
• Expertise in clinical trial design and regulatory requirements.

Responsibilities

• Provide strategic guidance on clinical evidence throughout product development.
• Lead scientific discussions with regulatory agencies for marketing authorization.

Skills

Clinical Research

Clinical Trial Design

Biostatistics

Regulatory Knowledge

Collaboration Skills

Report Writing

AI Algorithm Validation

Education

MD or PhD in Medical or Life Sciences

Job description

Join us to apply for the Clinical Development Scientist role at USDM Life Sciences

USDM Life Sciences is a premier consulting company with over 20 years of experience assisting heavily regulated biotech, medical device, and pharmaceutical companies with their GxP technologies to accelerate growth. Our expertise in life sciences business processes sets us apart. We deliver thousands of GxP projects globally, working with cutting-edge technologies through partnerships with companies like Microsoft, Google, Oracle, and others. Join us to help connect technology, people, and data to generate real-time insights and improve business outcomes for our clients. Founded in Santa Barbara in 1999, USDM has grown into a global company with 300+ remote employees across the US, Canada, and Germany.

Nature and Scope of Job

We are seeking an experienced Clinical Development Scientist to develop, generate, and disseminate clinical and economic evidence to foster innovation and transformation.

Primary Responsibilities

1. Provide strategic guidance on clinical and economic evidence throughout the product development lifecycle in the Ultrasound business.
2. Lead or support scientific discussions with regulatory agencies, including clinical investigations and review processes for marketing authorization and line extensions.
3. Collaborate with internal and external stakeholders to develop and lead clinical initiatives, strategies for new products, and lifecycle management.
4. Work with investigators, IRBs/ECs, regulatory bodies, and others to support claims, reimbursement, health economic outcomes, and market access. Prepare and interpret clinical evidence and reports.
5. Travel up to 15% domestically and internationally as needed.

Additional Responsibilities

Perform other related duties as required.

Qualifications

• 7+ years in clinical research/development or real-world evidence, with experience in AI algorithm validation.
• Expertise in clinical trial design, registries, quality initiatives, and data networks; biostatistics knowledge.
• Experience with medical device reporting protocols.
• Deep understanding of U.S. regulatory requirements; familiarity with China NMPA regulations is a plus.
• Knowledge of GCP, FDA, and EU-MDR regulations, and product development design controls.
• Strong skills in clinical documentation and report writing.
• Effective collaboration and influence skills across teams and externally.
• Ability to present statistical methods and results clearly to diverse audiences.

Education

• MD or PhD in a relevant medical, life sciences, or scientific discipline.

Working Conditions

Prolonged sitting or standing at a desk, working in a home office environment, and occasional communication with stakeholders via various channels. Reasonable accommodations will be provided for disabilities.

Equal Opportunity Statement

USDM Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration regardless of race, color, religion, sex, sexual orientation, gender identity, or other protected statuses.

Disclaimer

This job description describes the general nature and level of work performed. Responsibilities may change to meet organizational needs.

Compensation

Salary range: USD 80.00-90.00 per hour. Compensation varies based on qualifications and market data. Benefits include health, vision, dental insurance, 401k, paid time off, and recognition programs. For more details, visit usdm.com/careers.