About Us
Hansoh Pharma is a leading biopharmaceutical company in Asia. Founded in 1995, we are committed to discovering and developing life-changing medicines to help patients. Our rapidly growing workforce of 9,000+ employees, and our fully integrated research and development, manufacturing and commercial capabilities have propelled us into leadership positions across a broad range of therapeutic areas, including CNS, oncology, infectious disease, and metabolic disorders. With 1,400 professionals across multiple R&D functions, we rank 2nd in innovation among all Chinese biotech and pharmaceutical companies, based on new molecular entities developed for clinical development. Since an IPO on Hong Kong stock exchange in June 2019, we have raised $1.6B from global top-tier institutional investors; with a current equity value of approximately $27B, Hansoh is the 2nd largest biopharmaceutical companies in China and 6th largest in Asia by market capitalization. For more information, please visit www.hspharm.com.
Role Summary
We are seeking an experienced and highly motivated Medical Monitor to join our clinical development team in the U.S. at Hansoh Pharma. As a Medical Monitor, you will be a key medical expert responsible for overseeing the safety, integrity, and medical aspects of clinical trials. This role ensures that our clinical programs align with regulatory standards, ethical guidelines, and can generate strategic thoughts and ideas, ultimately supporting the development of innovative therapies.
Key Responsibilities
Clinical Trial Oversight
- Review clinical trial protocols, ensuring they are aligned with the latest scientific insights and are operationally feasible.
- Collaborate with study investigators and site staff to ensure a clear understanding of the protocol, study procedures, and regulatory requirements.
- Oversee the initiation, conduct, and closeout of clinical trials at investigative sites.
Medical Monitoring
- Conduct thorough medical review of case report forms (CRFs) and source documents to ensure accuracy and completeness of data.
- Evaluate and assess the safety and efficacy of investigational products through the review of clinical and laboratory data.
- Identify, document, and manage adverse events and serious adverse events, ensuring timely reporting to regulatory authorities, ethics committees, and company sponsors.
- Provide medical input and guidance on patient eligibility, inclusion/exclusion criteria, and protocol deviations.
- Perform regular site visits to ensure compliance with the protocol, GCP, and regulatory requirements.
- Review and approve protocol deviations, concomitant medications, and other study-related medical decisions.
- Monitor patient recruitment and retention strategies to ensure timely study completion.
- Ensure that patient safety is maintained throughout the trial and that any necessary actions are taken promptly in response to safety concerns.
Data Management and Quality Assurance
- Work closely with data management teams to resolve data queries and ensure data integrity.
- Participate in the development and review of data management plans, data validation plans, and data review protocols.
- Oversee the quality control process for clinical data, including the review of data listings and summary tables.
Regulatory Compliance
- Ensure that all study activities are conducted in accordance with GCP, ICH guidelines, and relevant local regulations.
- Assist in the preparation of regulatory submissions, including Investigational New Drug (IND) applications, annual reports, and safety updates.
- Support inspections and audits by regulatory authorities and internal quality assurance teams.
Team Collaboration and Communication
- Foster effective communication and collaboration with clinical operations, biostatistics, data management, and regulatory affairs teams.
- Provide medical expertise and support to the clinical project team to address study-related challenges.
- Present medical monitoring findings and updates to the project team and senior management.
Qualifications
Education and Certification
- MD degree from an accredited medical school.
- Board certification in medical oncology or a relevant subspecialty is highly preferred.
Experience
- At least 5 years of experience in clinical research, with a focus on oncology.
- Demonstrated experience in medical monitoring and adverse event management in Phase I clinical trial.
- With a good network with clinical research centers in the US
- With successful execution of clinical development programs in the US
Skills and Knowledge
- Comprehensive understanding of oncology diseases, treatment modalities, and current clinical research trends.
- Proficiency in clinical research regulations, including FDA and ICH guidelines.
- Strong analytical skills with the ability to interpret complex clinical data.
- Excellent written and verbal communication skills.