The Senior Clinical Research Scientist will support clinical trial strategy and design development, collaborating closely with internal stakeholders and external scientific advisors to develop innovative, evidence-based clinical programs. This role focuses on generating high-quality clinical evidence to support regulatory submissions, product development, and commercialization across T45 Labs’ portfolio of companies.
Responsibilities
You will be responsible for designing clinical trials, producing regulatory documentation, leading cross-functional teams, and driving clinical project implementation to meet early-stage medical device company needs.
Clinical Trial Strategy & Design
- Design clinical trial protocols to meet premarket and post-market evidence needs, ensuring alignment with regulatory standards and clinical goals.
- ·Strengthen capabilities in real-world evidence generation to enhance data-driven decision-making and market adoption.
Clinical Evidence Generation & Data Analysis
- Lead interpretation and dissemination of clinical evidence, including the development of manuscripts, abstracts, and presentations.
- Author clinical trial documentation, including protocols, clinical evaluation reports (CERs), and investigator brochures.
- Manage collaborations with Key Opinion Leaders (KOLs) to generate scientific insights and develop manuscript and abstract drafts.
- Partner with statisticians to integrate statistical analysis plans into regulatory and clinical documentation.
- Lead clinical data analysis and generate reports.
Regulatory Support & Compliance
- Support regulatory discussions to drive alignment between clinical and regulatory needs, including the design of clinical investigations and preparation for inspections.
- Ensure clinical evidence supports regulatory filings, marketing authorization, and post-market activities, complying with global clinical trial regulations.
- Author clinical sections of submissions and clinical data reports to support regulatory submissions.
- Advanced degree (MD, PhD, or MS) with 5+ years of industry clinical research experience in the medical device industry (preferably with cardiovascular products).
- Expertise in clinical trial design, and execution, including pre- and post-market studies.
- Strong scientific acumen with demonstrated success in manuscript development, literature reviews, and regulatory documentation.
- Exceptional written and verbal communication skills with the ability to convey complex scientific data effectively. (Samples required.)
- Demonstrated ability to multi-task, prioritize tasks, and anticipate challenges in a fast-paced environment.
- Collaborative mindset with a passion for innovation and technology-driven solutions.
- Located in the Bay Area (preferred), with the ability to work on-site at least one day per week.
- Willingness to travel (approximately 25%).
Location and Compensation
This position is open to remote candidates; however, preference will be given to applicants located in the San Francisco Bay Area. Candidates based in the Bay Area are generally expected to work in our Santa Clara office at least one day per week to support in-person collaboration and team activities.
T45 Labs and its affiliated companies are committed to fair and equitable pay practices and may also consider additional compensation elements such as bonuses, equity, and benefits as part of the total rewards package.
The anticipated salary range for this position is $149,000 - $201,000 annually, based on San Francisco Bay Area market data. Actual compensation offered may vary depending on factors such as experience, skills, qualifications, and abilities relevant to the role, as well as the geographic location of the individual hired.
Please note that the top of the salary range is reserved for candidates who demonstrate exceptional qualifications and experience directly aligned with the requirements of the role. Most candidates should expect to receive an offer within the mid-range of the posted range, based on these considerations.
Equal Employment Opportunity Statement
T45 Labs and its affiliated companies are Equal Opportunity Employers. We celebrate diversity and are committed to creating an inclusive environment for all employees. Employment decisions are based on qualifications, merit, and business needs.
We do not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other legally protected status.
