Medial Director (CP56NC361)

Location: Greensboro, NC,,

The Aixial Group is an International Contract Research Organization (CRO), a member of the ALTEN Group, with offices located in France, UK, US, Belgium, Denmark, Sweden, Switzerland, Romania, and India.

The CRO occupies a unique position in the clinical research industry, supporting biotech in clinical trials across all phases (Ph. I - IV) and non-interventional studies, as an expert in the operational delivery of clinical trials. Our vision is to conduct clinical trials better than anyone else, to help patients and ultimately save lives. We have earned a strong reputation for successfully delivering complex, demanding and innovative clinical trials, with specialist therapeutic expertise in oncology, cell & gene therapy, radiopharmaceuticals and rare diseases.

Purpose

Medical Director has accountabilities inclusive of medical and study vigilance activities plus department management responsibility.  The include, but are not limited to the following:

• Medical and safety monitoring activities.
• Therapeutic Area Training of Business Development, Project Team and Other Staff
• Support of Business Development Activities
• Department profit & loss management
•  Leadership/Line Management
• Vendor identification, qualification and management
• Department process management and continued development
• Strategic planning
• Audits and inspections
• Key performance indicators
• Non-conformities
• Other ad-hoc or permanent roles as assigned

All responsibilities and work performed on behalf of Aixial will follow all applicable local, regional, trial and product specific regulations. 

Responsibilities

Medical and Safety Monitoring (as outlined in the scope of work)

• Protocol synopsis, Full Protocol, Briefing Document (MHRA), pre-IND, IND application development if applicable
• Review, contribute to and/or generate:
  • Safety case documentation
  • Annual safety reporting
  • Project related documents
• Provide consultation:
  • Project team and investigative sites for protocol/project/therapeutic inquiries. 
  • Therapeutic area 
  • Study product training 
  • Protocol eligibility, acceptable medications, lab alerts, etc. 
• Manage and/or participate in data review or monitoring committees
• Accountable for all medical and safety aspects of products in clinical development, including individual case assessment, aggregate reporting, signal detection, risk management throughout the life cycle of the study.
  • Patients monitoring,
    • Evaluation, interpretation, and appropriate management of safety and/or efficacy data.
    • Includes initiation, review, and closure of safety queries.
    • Coding review for Concomitant Medications, Medical History, and Adverse Events (AEs)/Serious Adverse Events (SAEs)/AEs of Special Interest.
    • Protocol deviations review.
  • Medical review of tables and listings for trends.
  • Participate in the safety signal detection activities and global literature search for selected studies on the product/program level.
  • Analyze and assess the potential necessity for Protocol Amendments
• Additional tasks may include attendance and participation at Investigator Meetings, KOMs, Provide oversight of final SAEs/AEs reconciliation between clinical and safety databases.
• Ensure compliance with:
  • Global regulations including US Code of Federal (CFR) regulations; European Union
  • (EU) Volume 10 clinical trials directive and appropriate ICH guidelines

Project or Programme Oversight

• Lead projects teams and serve as point of escalation for customer accounts.
• Utilize pre-clinical and clinical experience to develop strategies for project or program delivery.  This applies from pre-sales through close of project.
• Works with global functional leaders and exter