Description
CATEGORY: Clinical Development
SCHEDULE: Full-Time, On-site/Hybrid
ABOUT US
CUGENE Inc. is a clinical-stage biotechnology company dedicated to the discovery and development of innovative medicines for the treatment of cancer and autoimmune diseases. Guided by our mission to improve lives, we harness the power of the immune system to combat disease. We are committed to fostering a diverse, inclusive, and ethical environment where innovation, integrity, and accountability are central to our culture. We deeply value our people and seek highly skilled, driven individuals who share our passion and commitment. Together, we strive toward one unified vision: One Passion, Many Cures.
POSITION SUMMARY
The Medical Monitor will provide medical leadership and oversight for early- to mid-phase clinical trials, with responsibility for patient safety, protocol development, medical decision-making, and regulatory interactions. This individual will work closely with the Head of R&D and crossfunctional teams to advance the clinical pipeline, including clinical trials conducted in US and Asia. The successful candidate will have deep expertise in immunology/autoimmune and immuno-oncology (solid tumor indications) and large-molecule biologics-based therapies. The candidate must be able to thrive in a fast-paced startup environment and has demonstrated experience guiding early clinical programs from first in human through proof of concept.
Requirements
KEY RESPONSIBILITIES
- Ensure individual participant’s safety and the scientific integrity of the trials in accordance of the guidance of ICH Good Clinical Practice (GCP), Standard Operating
- Procedures (SOPs) and local regulatory guidelines
- Provide real-time medical guidance to the clinical development teams including clinical operations, CROs, investigators, and vendors
- Provide medical support for routine medical inquiries and oncall medical support for urgent medical inquiries
- Review safety information, including adverse events and clinical laboratory data, to inform patient-level medical decisions when necessary
- Assess and manage immune-mediated toxicities
- Review medical raw data listings and coding listings, and assess protocol deviations
- Confirm patient eligibility based on IE criteria and medical history and concomitant medications
- Implement dose escalation/deescalation decisions, stopping rules, and toxicity management plans
- Assess clinical indications and medical needs in autoimmune and inflammation field, design clinical study and author study protocols
- Author and/or review key regulatory documents, including the study synopsis, CSRs, IB, CRF, ICF, medical monitoring plans, safety narratives, DSURs, and statical analysis plan and data package
- Serve as a key clinical point of contact for regulatory agencies and respond to questions related to clinical safety and trial conduct
QUALIFICATIONS
- MD or equivalent international medical degree
- 5+ years of clinical practice or medical residency in a relevant therapeutic specialty
- Preferable prior experience as a principal investigator, sub-investigator, or clinical research physician
- Preferrable clinical research and drug development experience leading early-phase (Phase I–II) immuno-oncology or autoimmune/inflammation trials with a strong preference for biologics-based immunotherapy
- Strong understanding of Immune-related adverse events (irAEs)
- Strong clinical trial design and execution ability
- Excellent written and verbal communication
- Demonstrated ability to work independently and effectively in a team environment
TRAVEL REQUIREMENTS
- Willingness and ability to travel domestically and internationally
WHY JOIN US
- Opportunity to shape clinical strategy at a critical growth stage
- High visibility and direct impact on pipeline success
- Collaborative, science-driven culture with global reach
COMPANY BENEFITS
- Medical insurance
- Dental insurance
- Paid time-off
- Sick leave
- 401 (K) Plan with Company Match
- Holidays
- Free on-site gym access
- On-site cafeteria
- Free parking
EQUAL EMPLOYMENT OPPORTUNITY
At Cugene, our workplace reflects the value of diversity and inclusion, and we recognize each employee as an integral part of our success. Cugene is an equal opportunity employer and is committed to equal opportunity for all employees and job applications without regard to race, color, religion, national origin, gender, sexual orientation, marital status, medical condition, disability, or veteran status.
A qualified candidate will be hired at the appropriate level commensurate with education and experience.
