Director, Medical Data Review- Sponsor Dedicated

Job Overview

Lead Functional Department of Medical Data Review professionals to efficiently produce databases that meet customer requirements.

Essential Functions
Represents clinical development function in study team meetings and associated workstreams
Accountable for overseeing and ensuring optimal medical monitoring (outsourced to CRO) and medical data review (FSP resource in house)
Accountable for overseeing recruitment from medical perspective (ie flawless eligibility review and diagnosis adjudication via independent committee)
Supporting protocol deviation review
Supporting protocol amendments
Supporting requests for information from regulatory authorities and ethics boards
Supporting preparations for and execution of investigator meetings, CRA trainings, and steering committee meetings
Ability to engage and work with Key Opinion Leaders or Scientific Advisors in the relevant therapeutic area to help develop scientific rationale for clinical trials
Develop and/or oversee the preparation of clinical development plans, study concept sheets, study protocols or regulatory documentation in collaboration with clinical and project team members for assigned indication(s)/products or with external partners for collaborative studies
Actively contribute to or oversee medical writing of medical sections of study protocols, investigator brochure and other regulatory documents
Manage the clinical team supporting the clinical trial
Manage, mentor and develop assigned staff, as appropriate
Co-leadership of trial teams
Oversee all aspects related to the scientific and medical risk in collaboration with the safety representative and other relevant stakeholders
Support the review, analysis and interpretation of study data
Support communication of study results as assigned
Stay up to date in the assigned therapeutic area and sub-area including oversight of significant new developments
Contribute to the progress of the organization by providing input into assigned business process improvement workstreams and tasks
Preferred: Previous experience as Associate/Medical director on Sponsor side; Previous experience in myasthenia gravis (clinical trials or clinical practice)

Qualifications
Medical Degree (Mandatory) - MD
Requires professional experience of 10+ years overall, and 3+ years in the execution of clinical trials as medical responsible with at least one clinical trial within neuroimmunology.
Previous experience in medical monitoring, medical data review, eligibility review during recruitment, presentations at investigator meetings and trainings, protocol writing, regulatory responses
Working knowledge of GCP, ICH, US FDA and EMA regulations

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.