Job Purpose

• Play a key role at all stages of clinical development for product programs, from the drug discovery stage, through product registrations in China and worldwide registration.
• Oversight for ongoing and planned product trials within rare disease therapeutic area, including immunology.
• Ensure China pipeline products/ new indications registration and life cycle maintenance for responsible new product.

Major Accountabilities

• Will be part of a team responsible for all scientific aspects of conceptualizing and planning trials, Will be part of a team responsible for the preparation/review of regulatory documents, IND annual reports, IND safety reports, investigator brochures, and development plans.
• Provides ongoing medical monitoring for clinical trials, including assessment of eligibility criteria, toxicity management, and drug safety surveillance.
• Ensures adherence to regulatory requirements of study conduct and industry standards of Good Clinical Practice.
• Coordinates the collection and analysis of clinical data for internal analysis and review.
• Will be part of a team responsible for managing the preparation and/or review of data listings, summary tables, study results, study reports, and clinical NDA sections.
• Prepares presentations for scientific conferences as well as for clinical study investigator meetings and expert advisory meetings. Develops manuscripts for publication in peer-reviewed journals.
• Will be part of a team responsible for defending the clinical development program before regulatory authorities. Provides scientific and clinical guidance to Biology, Toxicology, Clinical Trials Management, Biometrics, Global Drug Safety, Regulatory, and Project Management staff.
• Assists in the clinical evaluation of business development opportunities.
• Provide strategic and valuable medical analysis to support new product registration, possible trial waiver discussion or commitment study discussion locally.
• Work with project team to ensure pipeline products/ new indications successful registration in China.
• Build strong network with responsible disease key opinion leader.

Requirments

• MD, Pharma D, PhD, or master, with >3-year pharma industry experience in early stage clinical drug development.
• Proven record in clinical research studies, trial design, execution and oversight.
• Experience in the design of study protocols, consent forms, case report forms, database design, data analysis and the construction of appropriate tables and figures.
• Direct experience in the strategic, and tactical implementation of drug development.
• Well-developed sense of integrity, strong work ethic, scrupulous attention to detail, clear ability to establish and maintain timelines, and persistent commitment to ensuring a high level of quality.
• Background in immunology or haematology is preferred.
• Good teamwork and collaboration skills.