As a key leader within the General Medicine organization, you will interact with senior management, customers, business development, and project teams to coordinate clinical trials and other services for the GIGU Business Unit. Provide direction and strategy for the growth of the GIGU portfolio and provide consulting, as needed. Additionally you will provide scientific and therapeutic consultation, project management and oversight and direction as needed. Will be expected to actively participate in company initiatives and development.
• Provides overall strategy and direction of clinical trials, processes and procedures.
• Acts as Scientific Director / consultant as required by the needs of the projects.
• Acts as a primary senior-level contact for customers.
• Participates in customer proposals, Request for Information (RFIs), presentations, proposal defenses and Steering Committees.
• Provides scientific/regulatory oversight and project/therapeutic training to project teams.
• Interacts and collaborates with the Medical Writing department in the preparation of clinical development plans, protocols, investigator brochures, and medical/clinical reports, as required
• Responsible for coordinating the acquisition of necessary medical/scientific input from outside experts/consultants/advisors.
• Represents the Company by attending industry meetings, speaking engagements, participating in booth exhibitions, etc., and by publishing scientific or industry related articles in industry journals.
• Participates in the development of Standard Operating Procedures (SOPs), medical/scientific tools, training, staffing requirements, etc.
• Interacts with senior management and contributes scientific/medical input to other departments, as appropriate.
• Ensures quality standards are set and maintained over all areas of responsibility.
• Other tasks and duties as determined appropriate by Executive Management.
• Extensive clinical research management experience with related degree and academic qualification.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), email, and voicemail.
• In-depth knowledge of Regulatory Authority regulations and strong understanding and usage of medical terminology.
• Ability to handle multiple tasks to meet deadlines in a dynamic environment.
• Effective organizational, presentation, documentation and interpersonal skills.
• Experience working in a matrixed team environment is preferred.
• Must have valid, current driver’s license and ability to secure corporate credit card.
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.