As a Principal Scientist at KCAS Bio, you will serve as the senior scientific authority within the assigned business unit, providing strategic leadership and ultimate accountability for the scientific quality and integrity of all assigned studies.
You will lead end-to-end study oversight—including study design, method development, validation, execution, data interpretation, and reporting—ensuring alignment with the highest standards of scientific rigor, regulatory compliance, and data integrity.
In this role, you will act as a recognized subject matter expert, shaping scientific strategy, establishing best practices, advancing innovation, and mentoring the next generation of scientific leaders, while representing KCAS Bio as a trusted scientific partner to clients, sponsors, and the broader scientific community.
In this role, we will rely on you to:
- Serve as the final scientific authority for complex bioanalytical validations and biostudies, providing oversight and approval of scientific strategy, execution, and interpretation.
- Set scientific direction and standards within the business unit to ensure consistent, high‑quality scientific output across programs.
- Provide strategic oversight of method development, validation, and study execution, particularly for complex or high‑risk programs.
- Independently review, interpret, approve, and communicate study results with scientific staff, sponsors, and internal leadership.
- Provide high‑level scientific leadership in sponsor meetings, regulatory interactions, audits, and scientific defense of study data.
- Lead the evaluation, adoption, and integration of new technologies and methodologies aligned with long‑term organizational strategy.
- Direct and manage scientific staff, including workload prioritization, performance evaluations, salary reviews, mentoring, and succession planning.
- Develop and elevate scientific capabilities of the organization through coaching, training, and leadership development of senior scientific staff.
- Ensure effective cross‑functional communication and collaboration to align expertise and solve complex analytical challenges.
- Author, review, and approve high‑impact scientific documents, protocols, and final reports.
- Represent KCAS Bio at scientific conferences and professional meetings through presentations, posters, or invited talks to maintain external scientific visibility.
- Ensure proper archiving and documentation of study data and reports in accordance with regulatory and quality requirements.
- Perform other related duties as assigned.
To qualify specifically for this role, you will have:
- Master’s degree or higher in a scientific discipline.
- 13–15+ years of relevant experience in CRO, pharmaceutical, or academic research environments.
- Demonstrated record of sustained scientific leadership, innovation, and delivery of complex, high‑visibility programs.
- Expert understanding of bioanalytical science, GLP regulations, scientific risk management, and quality systems.
- Proven ability to manage multiple high‑complexity programs simultaneously while meeting timelines and quality expectations.
- Recognized expert in applicable laboratory techniques and bioanalytical methodologies.
- Strategic scientific thinking with organizational‑level influence.
- Strong leadership, mentoring, and decision‑making capabilities.
- Exceptional communication skills with the ability to convey complex scientific concepts clearly to diverse audiences.
- Commitment to advancing scientific excellence, client trust, and KCAS Bio’s scientific reputation.
Top Skills
What We Do
With its presence in three locations across North America and Europe, KCAS Bio is a leading contract research organization (CRO) employing top scientific talent and providing comprehensive bioanalytical services to the global biopharmaceutical industry from early discovery support through product registration and beyond. The collaboration of the three entities allows for global support in bioanalytical, biomarker, immunogenicity, cellular and molecular assay services along with clinical kitting and sample management. The KCAS family of companies operates in state-of-the-art facilities in the United States and Europe. This business structure enables the expertise, capacity, and flexibility to support the development of all types of drugs, biologics, cell and gene therapies to improve health worldwide. Our purpose is to help accelerate the discovery and development of life-changing drugs smoothly, safely and sustainably.
