About this opportunity
Cugene, Inc. lists this Clinical Science & Medical Monitor opportunity in waltham, Massachusetts. Review the employer’s description below for duties, qualifications and application requirements.
Job 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.
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.
#J-18808-Ljbffr
Worksite address
waltham, MA, 02254, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.