Medical Director - 956

The Medical Director serves as the primary medical point of contact for a project or study. The Medical Director effectively manages medical and safety review, processes, and projects inclusive of medical and safety monitoring for assigned clinical studies. The Medical Director, may be an employee, or a consultant may fill this role for a given period of time.

Responsibilities:

• Assists with RFP/RFI completion and attends sales meetings as requested by Business Development via travel for face to face meeting as well as webinars
• Manages and conducts medical monitoring activities during the course of clinical trials and projects
• Oversees medical review of key clinical documents, individual case safety reports, and medical or safety-related regulatory documents
• Provides support and input into the planning, design, preparation, initiation, and execution of study protocols and other required documentation in compliance with project plans, federal regulations, GCP, and good medical practice.
• May participate in the evaluation and selection of investigators and study sites as well as analysis of medical activities
• Ensures delivery of medical/clinical direction to investigative sites per contract deliverables
• Prepares medical and safety plans for clinical trials/services
• Oversees collection, review, guidance and manages overall safety case processing as dictated by client contracts
• Oversees reviews and directs medical and safety sections of regulatory document submissions
• Reviews and analyzes safety and efficacy trends
• May participate in Investigator meetings, Team Meetings, DSMB and Safety Review Meetings
• Develops, trains and assists other staff in the development of processes, timelines, planning, and strategy
• Facilitates collaboration and communication with medical/scientific personnel and ensures that the most current research information is accessible for review
• Contributes to the development of global strategy and execution of Company's oncology portfolio;
• Represents Advanced Clinical to internal and external stakeholders inclusive of key opinion/thought leaders, key personnel (current and future, and clients;
• Oversees and coordinates the collaboration of internal and external medical personnel;
• Builds up, maintains and develops the KOL network in their specified therapeutic area;
• Builds up, maintains and develops the internal training database in their specified therapeutic area;
• Contributes to the development of medical-related standard procedures and working activities
• Provides therapeutic and project specific training
• Provide medical monitoring for ongoing clinical studies for other therapy areas outside of the key indication, as required by the company

Qualifications:

• Experience: Minimum of seven (7) in clinical research and medical/safety management experience in the pharmaceutical industry ideally including in Oncology
• Education: MD required, preferred hematology and oncology experience, additional therapeutic experience would be a 'plus'.
• Requires an excellent understanding of the clinical/pharmaceutical process so as to effectively communicate and create required deliverables.
• Possesses advanced knowledge of, and ability to, apply GCP and all applicable regulations and guidelines. Possesses exceptional leadership skills and proven industry vision.
• Requires effective negotiation and interpersonal communication skills to interact with a variety of peers and constituents.
• Must have the ability to understand complex clinical and statistical data and issues from an analytic standpoint.
• Training GCP (including 21 CFR 11), HIPAA - Privacy Rule and Protected Health Information and/or GDPR
• Certification: Preferably board certified in the US- Medical License or local equivalent to practice medicine