Clinical Development Scientist

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

Job summary

An innovative consulting firm is seeking a Clinical Development Scientist to lead the development of clinical and economic evidence in the medical device sector. This role involves strategic guidance throughout the product development process, collaboration with regulatory agencies, and the creation of clinical documents. With a focus on cutting-edge technologies, you'll help drive digital transformation in life sciences. Join a dynamic team dedicated to improving healthcare outcomes through evidence-based practices and innovative solutions. If you're passionate about making a significant impact in a rapidly evolving industry, this opportunity is for you.

Benefits

Health Insurance

Vision Insurance

Dental Insurance

401k Plan

Paid Time Off

Rewards and Recognition Program

Qualifications

• 7+ years of experience in clinical research and development.
• Expertise in U.S. regulatory requirements and clinical trial design.

Responsibilities

• Contribute strategic guidance for clinical evidence development.
• Lead scientific discussions with regulatory agencies.
• Collaborate on clinical initiatives for product life cycle management.

Skills

Clinical Research

Artificial Intelligence

Scientific Study Design

Biostatistics

Regulatory Requirements

Writing Skills

Analytical Thinking

Education

MD or PhD in Life Sciences

Job description

About USDM

USDM Life Sciences is a premier consulting company with 20+ years of experience assisting heavily regulated biotech, medical device, and pharmaceutical companies with their GxP technologies to accelerate growth. Our deep domain knowledge and technology expertise in life sciences business processes are what sets us apart. From strategy to implementation and adoption, we have delivered thousands of GxP projects globally. As part of the USDM team, you have the opportunity to work with cutting edge technologies through our many partnerships with companies like Microsoft, Google, Oracle, DocuSign, Box, and many more. From molecule to market, you will help connect technology, people, and data in new ways to generate real-time insights to improve business outcomes for USDM's clients. Are you ready to make an impact and drive real digital transformation in life sciences? Founded in Santa Barbara in 1999, USDM has grown to a progressive, global company with 300+ remote employees and offices throughout the US, Canada, and Germany.

Nature and Scope of Job

USDM Life Sciences is seeking an experienced Clinical Development Scientist to develop, generate, and disseminate clinical and economic evidence to ensure innovation, and transformation.

Primary Responsibilities

• Contribute strategic guidance for clinical and economic evidence related to the end to end (E2E) development process from ideation through post-market for products in the Ultrasound business.
• Lead or support scientific discussions with regulatory agencies or notified bodies, including proposed clinical investigations; review process of clinical evidence generated for marketing authorization, in line extensions, including during sponsor regulatory inspections.
• Collaborate with key internal and external stakeholders to provide in-depth expertise to develop and lead clinical initiatives through non-clinical and clinical strategies for new product development initiatives and product life cycle management.
• Collaborate with investigators, IRBs/ECs, Regulatory Agencies, societies, and associations; and additionally, to support claims, reimbursement, health economic outcomes and/or market access. Ensure appropriate preparation, interpretation and dissemination of all evidence generated, including Clinical Study Reports (CSRs), Clinical Evaluation Reports (CERs), abstracts, peer-reviewed manuscripts, as assigned.
• Travel up to 15% (domestic and international) according to business needs.

Additional Responsibilities

• Performs other related duties and assignments as required.

Qualifications

• 7+ years of experience in clinical research/development/real world evidence (RWE); scientific study design, strong scientific background and experience with Artificial Intelligence algorithm clinical performance validation.
• Deep expertise with innovative clinical trial design, registries, quality improvement initiatives, and creation of data networks and working knowledge of biostatistics.
• Hands-on experience with reporting protocols specific to the medical device sector.
• Expertise in U.S. regulatory requirements is required. (Familiarity with China NMPA regulations is highly preferred).
• Demonstrated working knowledge of GCP, FDA regulations and EU-MDR regulations, and in-depth understanding of product development and associated design controls for medical devices.
• Strong writing skills to product quality clinical documents, including final reports.
• Strong work ethic, agile, and have an ability to work in a purposeful environment.
• Collaborate effectively and influence decision making with various teams cross-functionally, as well as externally.
• Ability to think analytically, present statistical methods and results to a variety of audiences, especially non-statisticians.

Education

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

Working Conditions

The working conditions described here are representative of those that must be met by an employee to successfully perform the essential responsibilities and functions of the job and are not meant to be all inclusive. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential responsibilities and functions of the job. Unless reasonable accommodations can be made, while performing this job the staff member shall:

• Prolonged periods of sitting or standing at a desk and working on a computer in an environmentally controlled home office environment.
• Operate other office productivity machinery, such as a calculator, scanner, or printer.
• Frequently communicate with stakeholders via telephone, email, or instant message. Must be able to exchange accurate information in these situations.

Equal Opportunity Statement

USDM Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Disclaimer

This job description is intended to describe the general nature and the level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. USDM Life Sciences reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

Compensation

Salary/Hourly Rate Range (W2): USD 80.00- 90.00

The base salary/hourly rate range represents the anticipated low and high end of the USDM's compensation range for this position. Actual salaries/hourly rates will vary and will be based on various factors, such as the candidate's qualifications, skills, competencies, and proficiency for the role. The compensation described above is subject to change and could be higher or lower than the range described based on market survey data or budget.Full-time employees are eligible for health, vision, and dental insurance, life insurance, short and long-term disability, hospital indemnity, accident, and critical care coverage. Both full and part-time employees, who are at least 21 years of age, are eligible to participate in USDM's 401k plan.Full and part-time employees may be eligible for paid time off.All employees are eligible for USDM's rewards and recognition program.

For more details about our benefits, visit us here: https://usdm.com/careers