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Job Descriptions

Clinical Scientist, Level 1

Position Summary

CRC Oncology is seeking for a Clinical Scientist (title commensurate with experience) in the clinical development for oncology indications. The position is responsible for various aspects of ongoing clinical development activities. These activities include, but are not limited to, competitive landscape research, clinical trial publications review and summary, clinical trial protocol development/amendment, clinical trial results publications drafting and reviewing, and support regulatory responses/NDA/MAA filings.

Responsibilities

• Acquires and utilizes the data from clinical trial publications to conduct the landscape research and support the clinical development plan development
• Acquires and utilizes knowledge of clinical trial design to support the development of clinical trial synopsis and protocol
• Participates in protocol review discussions concerning scientific and procedural aspects of study design
• In collaboration with Medical Writing and Clinical Operations, prepares study protocols, amendments, specific sections of study manuals and Investigator meeting materials, and other documents as needed with guidance and supervision
• In collaboration with Data Management and, with Clinical Development supervision where needed, contributes to the design and development of CRFs, Data Management Manuals, and Data Analysis Plans
• With MD supervision, addresses questions regarding scientific and related procedural issues from Investigators
• Contributes to the preparation and/or review of data listings, summary tables, study results, manuscripts, and scientific presentations
• Assists in the preparation and review of regulatory documents, IND annual reports, IND safety reports, Investigator Brochures, and NDAs/MAAs
• Anticipates common obstacles within a clinical study and, with guidance, implements solutions
• May be asked to coordinate teams and provide direction
• May lead one or more specific components of departmental strategic initiatives
• Must be able to enter a new therapeutic area with guidance and summarize scientific information that is available in the published literature to integrate into new study development
• Excellent verbal and written communication skills and interpersonal skills are required to maintain a working relationship with team members to ensure the scientific integrity of clinical studies
• May be sought out for advice by others within the company to help make better decisions and resolve common problems

Qualifications

• PhD in Pharmacology required, open to entry level and newly graduated candidates
• Must be bilingual (Fluent in English and Chinese)
• Demonstrates ability to successfully manage a full workload across multiple projects.
• Excellent interpersonal, verbal and written communication skills (including experience in making presentations at conferences, meetings, training sessions)

Employment Type

Full-time