Director, Medical Affairs

Company: Cato Sms
Location: Cary
Posted on: January 16, 2022

Job Description:

CATO SMS is a full-service contract research and development organization with international resources dedicated to helping pharmaceutical and biotechnology companies efficiently and expeditiously navigate the regulatory approval process in order to bring new drugs, biologics, and medical devices to the people who need them. CATO SMS is a non-laboratory environment.

We are currently recruiting for Director of Medical Affairs to join our team in the United States or Canada location with the option to work remotely. The Director, Medical Affairs (DMA) leads, develops and coordinates activities of the Medical Affairs of CATO SMS. The DMA is responsible for managing subject safety and scientific integrity of clinical trials, providing scientific and clinical advice for medical aspects of projects. The DMA supervises the - according to the organization chart - to him/her reporting departments. The DMA is member of the Medical Affairs Director team.

Responsibilities:

• Contribute to the identification, development and implementation of the business strategy for the Medical Affairs
• Contribute to development of annual revenues, sales, profit and operational targets for the Medical Affairs
• Evaluate and contribute to the development of the area strategy and tactics planning
• Develop and agree upon operating procedures / business processes
• Manage direct reporting staff
• Ensure the availability of required capable resources for the area
• Collaborate and ensure open communication with other areas
• Report to the leaderships team
• Ensure activities meet and integrate with organizational requirements for quality management, health and safety, legal stipulations, environmental policies and general duty of care
• Responsible for review of subject safety by ensuring reporting of safety data according to applicable agreements, guidelines and legislation; interpretation of trends emerging from safety data
• Responsible for review of scientific integrity of projects by medical review of data, monitoring adherence to protocol, ensuring reporting to Sponsor with regard to consistency and scientific validity of data
• Plan, develop and implement strategy and processes to perform review and analysis of ongoing trials and to provide clients with insight and analytics reports
• Collaboration with operational staff such as Project Directors, Project Managers, CRAs and Clinical Data Managers
• Involved in providing medical, oncology, scientific and study related training to Sponsors and company staff as needed
• Locates and engages external therapeutic (oncology) key opinion leaders (KOLs)/experts/consultants/advisors as necessary to provide medical/scientific input and build up an extensive network for CATO SMS
• Manage and control departmental expenditure within agreed budgets
• Ensure medical monitoring processes required for the quality management system are defined, implemented d maintained
• Reviewing and providing input on scientific and medical aspects of proposals, consultancy reports and clinical development plans
• Assist in business development activities, incl. client consultations/meetings, proposals and contracts, and bid defense meetings as required
• Perform medical monitoring and pharmacovigilance tasks
  
  Requirements
  
  Qualifications:
  
  • MD degree
  • Minimum 6 years of relevant work experience
  • Minimum 4 years of experience in drug development and/or clinical research
  • Thorough knowledge of ICH-GCP
  • GDPR/HIPPA, CFR/CTR/CTD and applicable (local) regulatory requirements
    
    Skills:
    
    • Strong written and verbal communication skills including good command of English language
    • Representative, outgoing and client focused
    • Ability to work in a fast-paced challenging environment of a growing company
    • Administrative excellence
    • Proficiency with various computer applications such as Word, Excel, and PowerPoint required
    • Strong leadership skills
    • Effective at problem solving, strategic thinking and conflict resolution
    • Strong presentation and networking capabilities
    • Excellent organizational, negotiating and financial skills
      
      Equal Employment Opportunity and Affirmative Action
      
      Cato Research LLC is committed to Equal Employment Opportunity and Affirmative Action. We recruit, hire, train and promote qualified persons in all job titles and ensure that all other personnel actions are administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, marital status, military and/or veteran status, or disability. Furthermore, to the extent required by applicable laws and/or Executive Orders, we take affirmative action to ensure that minority group individuals, females, disabled veterans, recently separated veterans, other protected veterans, Armed Forces service medal veterans, and qualified disabled persons are introduced into our workforce and considered for promotional opportunities. Cato Research, LLC is committed to providing reasonable accommodations to employees and applicants with disabilities to the full extent required by the Americans with Disabilities Act - ADA. If you feel you need a reasonable accommodation pursuant to the ADA, you are encouraged to contact us at 919.361.2286.by Jobble

Keywords: Cato Sms, Cary , Director, Medical Affairs, Executive , Cary, North Carolina