Job Description

Provide strong scientific and operational support to clinical development activities in a biotech company setting. Support global clinical operations and project management to deliver early phase clinical trials in company\'s expanding portfolio on time, with quality and within budget.

• According to the requirements of GCP and ICH, provide scientific and operational support for phase I and II studies.
• Work closely with matrix teams to ensure completion of clinical studies on time, with high quality and within budget.
• Provide expertise on literature research, data analysis, medical writing, scientific presentation, strategic planning to support drug development projects and clinical studies.
• Lead or coordinate development of key study documents including protocols, investigators brochures, informed consent forms, data analysis, and study report.
• Coordinate internal preclinical and clinical functions, CROs, investigators, and regulatory agents, to deliver study planning, conduct and conclusion.
• Create, maintain, and archive clinical records and documents in internal clinical systems.
• Maintain seamless communication with internal and external collaborators.

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual\'s status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

Provide operational support to clinical development activities |Clinical-stage global biotech company developing novel drugs and therapies

• Master or PhD degree in life science disciplines
• Over 2 years of experience in clinical operations for early phase clinical trials
• Having track record of scientific research in academic and/or industrial settings
• Strong experience in scientific writing, statistical analysis, presentation and publication
• Good knowledge of GCP/ICH Guidelines
• Knowledge of regulatory and compliance requirements for global clinical research
• Knowledge of clinical development plan and project financial principles
• Experience in the fields of metabolic, cardiovascular, and/or immunological diseases is preferred
• Experience in multi-center, cross-geography clinical operations and project management is preferred
• Risks anticipation/identification and problem solving with appropriate action
• Independent, responsible, and detail-orientated team worker

Our client is a clinical-staged biotechnology company which develops drugs and therapies across the metabolic and immune-related disease spaces. The organization has a variety of programs in different stages. They are Chinese based and growing their business in the United States, with plans to establish a Boston office in the near future. This is a fully remote role, with a strong preference of the candidate being located in Massachusetts or Pennsylvania.

• Competitive base salary
• Fully remote role (prefer candidate to be located in MA of PA)
• Long term incentives.
• High-growth potential biotech company with diverse pipeline.
• The ability to work with well established, industry experts and a main share holder with deep, global connections.
• Equity.
• Reporting directly to Medical Director - Head of Clinical Operations
• Great financial backing.
• Strong annual bonus incentive
• Excellent benefits package

Michael Page