Overview In this role you will drive clinical evidence generation and co-develop companion diagnostics in oncology, collaborating with cross-functional teams and external partners. You will shape trial design, regulatory submissions, and guidance for marketing materials, ensuring scientific rigor and regulatory compliance. You'll lead content creation for validation studies, oversee data integrity, and provide SME input in meetings with partners and regulators. This is a pivotal, hands-on role in a global Clinical Affairs team that translates science into clinically impactful diagnostics.
Compensation / Benefits- remote work option
- competitive pay
- bonus eligibility
- stock options
- comprehensive benefits
Responsibilities- Provide thought leadership to support strategy and execution on clinical topics
- Generate content for external validation studies, including study design and protocol/report writing
- Contribute to cutoff/cutpoint studies, method comparison, bridging, and analytical concordance studies
- Design and develop databases, EDC systems, and case report forms
- Contribute to risk analyses, trial quality control, and data monitoring
- Ensure scientific validity of results including statistical analysis, tabulation, and presentation
- Collaborate with regulatory and development teams during submissions and draft clinical performance information and IFUs
- Provide clinical/scientific oversight of local marketing and commercial materials
- Prepare, revise, and maintain standard operating procedures for clinical studies
- Serve as clinical science SME in internal and external meetings and audits
- Author manuscripts, abstracts, whitepapers, and prepare oral/poster presentations
- Support audits and inspections as a clinical SME
Key requirements- Master's degree or advanced degree in pharmaceutical, medical or relevant biomedical science fields
- 4+ years of experience in IVD product development, clinical research, medical writing, or clinical science in medical device/pharma
- Familiarity with clinical trial design, conduct, oversight, biostatistics, and GCP preferred
- Ability to interpret regulatory standards, guidance, and laws
- Strong scientific, medical writing, and presentation skills
- Ability to manage multiple projects in a fast-paced environment and work independently
- Experience with external partners and regulatory bodies including the FDA
- Knowledge in oncology, immunology, and/or pathology preferred
- Strong scientific communication
- Cross-functional collaboration
- Independent decision-making
- Clinical trial design and oversight
- Biostatistics basics
- EDC systems design and use
