Job description
Join LuminaBio Therapeutics, a premier leader in specialized medicine research, advancing breakthrough therapies for rare diseases and precision oncology. This senior role blends scientific excellence with strategic leadership to drive high-impact programs.
As a Senior Clinical Research Scientist, you will lead cross-functional teams through complex clinical trials, observational studies, and real-world evidence initiatives, ensuring patient safety, data integrity, and regulatory compliance.
We seek a collaborative, results-driven professional who can translate scientific insights into actionable study plans, mentor junior teammates, and partner with medical affairs, regulatory affairs, and operations to deliver high-quality outcomes.
Responsibility
- Lead development and execution of clinical trial protocols in specialized medicine (oncology, rare diseases) with adherence to GCP, ICH guidelines, and regulatory expectations.
- Oversee study design, feasibility assessments, statistical considerations, and data management plans in collaboration with Biostatistics and Data Science teams.
- Manage cross-functional teams (Clinical Operations, Medical Writing, Pharmacovigilance) and external vendors to ensure timeliness and quality.
- Monitor safety and risk management, oversee adverse event reporting, periodic safety updates, and safety signal escalation.
- Collaborate with Medical Affairs to develop trial-related publications, abstracts, and presentations for scientific meetings.
- Lead regulatory interactions and submissions (FDA, EMA) with accurate documentation and audit readiness.
- Mentor and develop junior scientists, foster a culture of continuous improvement and knowledge sharing.
Qualification
- PhD in Life Sciences, MD, or equivalent; minimum of 7 years in clinical research with a focus on specialized medicine (oncology or rare diseases).
- Strong expertise in ICH-GCP, FDA/EMA guidelines, and regulatory submission processes; experience with EDC systems.
- Proven track record delivering complex trials on time and within budget, with high-quality data and robust risk management.
- Excellent scientific writing and communication skills; demonstrated ability to influence senior stakeholders across functions.
- Experience leading cross-functional teams and vendors; project management certification or demonstrated leadership is a plus.
- Proficiency in statistical thinking, data visualization, and use of clinical data analysis tools (e.g., SAS/R) is preferred.
- Willingness to travel up to 15-20% for site visits and conferences.