Clinician

POSITION PURPOSE:
Serves as a single point of accountability for monitoring, analysis, closeout, and reporting/publication of malaria clinical studies.

DUTIES/RESPONSIBILITIES:

- Drive scientific and technical excellence in the team
- Collaborate as appropriate with other groups
- Insert regulatory/medical standards into clinical study reports.
- Develop clinical documents
- Understands current state of the art in the treatment of malaria In pregnancy including, but not limited to intermittent preventive treatment of malaria in pregnancy
- Medical oversight of studies, in particular for safety reviews, assessment of overall risk: benefit ratio, and analysis and reporting of the malaria clinical studies
- Guides development of and adherence to a Safety Review Plan, a Clinical Plan, and a Safety Reporting Plan
- Reviews and documents safety data on a regular basis
- Maintains and enhances knowledge in relevant technical areas and in global regulations/guidelines
- Contributes clinical information to regulatory documents
- May present information regarding the studies to various audiences

STUDY PLANNING AND FACILITATION

- Provides clinical input to team
- Oversees work of team
- Manages and initiates external collaboration to develop new capabilities and to investigate new technologies

STUDY CONDUCT AND MONITORING

- Tracks changes in the drug profile throughout development
- Ensures high quality of data
- Has knowledge if the safety profiles of all drugs in the various studies
- Initiates protocol amendments
- Keep Senior Management informed of any critical issues

STUDY ANALYSIS AND REPORTING

- Reviews and interprets data
- Accountable for overall quality timeliness of analysis and reporting
- Drives clinical interpretation of study data
- Leads or assists in the development of publications designated in the Publications Plan

REGULATORY INTERACTIONS AND DOCUMENTS

- Prepares clinical/regulatory documents
- Leads discussions with regulators and drug regulatory agencies
- Leads or contributes to writing and review responses to regulatory queries

SKILLS:

MS Word

- Demonstrated ability to design, initiate, conduct, analyze, and report on clinical studies
- Ability to review and understand the emerging safety and efficacy profile of the drug candidate
- Demonstrated understanding of the complexities and recent developments in the relevant technical area, and the ability to apply such knowledge to drug development
- Demonstrates ability to present clinical data, study plans and tactics clearly and accurately to relevant audiences
- MD with a minimum of 2 years of clinical development experience.
- Demonstrated technical, administrative, and project management capabilities are required
- Effective verbal and written communication skills
- Postgraduate training/certification/fellowship in a medical discipline or in drug development
- Demonstrated scientific productivity (eg publications, research reports, etc)
- Thorough understanding of local and international regulations applicable to clinical development
- Practical experience in clinical trial strategies, methods and processes
- Previous leadership/management training - documented experience and proficiency in managing direct reports and/or Matrix teams