CSO(최고과학책임자) 직무기술서

Company overview

We are an international biotech, medical device, or digital health company with headquarters in [Europe / Asia / EMEA / LatAm], and a growing presence in the United States. As we expand our scientific and clinical footprint across North America, we are seeking a mission-driven Chief Scientific Officer (CSO) to lead innovation, drive product development, and shape our long-term scientific strategy in the U.S. This executive will serve as a vital bridge between global R&D and local execution, ensuring our science translates into real-world healthcare impact.

CSO role summary

The Chief Scientific Officer will serve as the most senior science executive in the U.S., responsible for scientific leadership across preclinical and clinical programs, innovation strategy, and external partnerships. You will collaborate with global and local teams to steer scientific priorities, guide regulatory strategy, and ensure alignment between innovation and commercial objectives. The ideal candidate brings deep scientific expertise, strong leadership, and experience in regulated healthcare environments.

CSO key responsibilities

Scientific Strategy & Innovation

Define and lead the U.S. scientific strategy in alignment with global R&D priorities. Translate innovation into clinical and commercial impact.

Clinical Development & Evidence Generation

Oversee design and execution of clinical trials and real-world evidence programs to support product development, market access, and post-market surveillance.

Regulatory & Scientific Affairs

Partner with Regulatory and Quality to ensure scientific inputs into U.S. regulatory submissions (FDA, CMS) meet industry and ethical standards.

External Collaborations

Engage with KOLs, academic institutions, CROs, and strategic partners to build scientific credibility and accelerate development pipelines.

Scientific Governance

Chair scientific advisory boards and review committees. Drive ethical standards, publication strategies, and internal review of scientific data.

Cross-Functional Partnership

Work closely with the CEO, CMO, CTO, and commercial teams to align science with business priorities, product strategy, and market needs.

Talent Development

Build and mentor high-performing teams of scientists, researchers, and clinical leaders. Foster a collaborative, purpose-driven, and performance-based culture.

Candidate profile

Experience

15+ years in scientific leadership roles within biotech, medical device, diagnostics, or digital health sectors in the U.S.

Scientific Credentials

Ph.D., M.D., or equivalent in a relevant life science or clinical discipline. Proven experience in translational science and clinical research.

Regulatory Insight

Familiarity with IND, IDE, and FDA pathways for diagnostics, therapeutics, and medical technologies.

Scientific Communication

Strong publication record, conference presence, and experience engaging with academic, regulatory, and investor audiences.

Leadership Style

Strategic and visionary thinker with hands-on execution ability. Culturally agile and collaborative.

Education

Advanced scientific degree (Ph.D., M.D., or dual-degree). Additional business training (MBA, MPH) is a plus.

Company culture and leadership style

We operate with scientific rigor and commercial agility. Our U.S. team is diverse, entrepreneurial, and mission-focused. The CSO must thrive at the intersection of innovation and execution, bringing scientific leadership that advances health outcomes and business success.

Compensation and benefits

Why the Chief Scientific Officer matters

The CSO will shape the scientific foundation of our U.S. growth. You will ensure that our innovations are not only breakthrough but also clinically validated, regulatory ready, and market aligned — helping bring life-changing solutions to patients faster.