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Senior Medical Director: Infectious Diseases

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Primary Location: Reading, Berkshire, United Kingdom Additonal Locations: Amsterdam, Netherlands,NLD; Barcelona, Spain,ESP; Belgrade, Serbia,SRB; Bratislava, Slovakia,SVK; Bucharest, Romania,ROU; Budapest, Hungary,HUN; Copenhagen, Denmark,DNK; Dublin, Ireland,IRL; Espoo, Finland,FIN; Kaunas, Lithuania,LTU; Ljubljana, Slovenia,SVN; Madrid, Spain,ESP; Milan, Italy,ITA; Oeiras, Portugal,PRT; Oslo, Norway,NOR; Prague, Czech Republic,CZE; Riga, Latvia,LVA; Sarajevo, Bosnia,BIH; Sofia, Bulgaria,BGR; Solna, Sweden,SWE; Tallinn, Estonia,EST; Vienna, Austria,AUT; Warsaw, Poland,POL; Zagreb, Croatia,HRV Full time R1316533

Job description

"IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.    

Why IQVIA? Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. In your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and, ultimately, improve outcomes for patients.

The Senior Director, Medical provides senior medical, clinical and scientific advisory expertise to IQVIA Biotech divisions. In the role of Medical Monitor, the Senior Director, Medical provides medical oversight as the first line of support for clinical trials to which he/she is assigned as medical monitor. As such, the Senior Director, Medical provides medical and scientific oversight of all aspects of medical involvement on proposed and/or assigned studies including support of pre-award/proposal activities and support to study teams and investigators of awarded studies. The Senior Director, Medical serves as a medical expert throughout business development activities by developing and supporting the medical strategy.

As the Senior Director, Medical you will provide management of assigned staff, and provide administrative leadership to the Medical Department by assisting the VP, Medical with delegated roles and responsibilities of managing the daily affairs of the department.

Essential Functions

  • Medical Monitoring

Clinical Activities:

  • Per sponsor request, reviewing and providing input for protocol development; interacting with key thought leaders and/or sponsor representatives to develop inclusion/exclusion criteria and study endpoints; interacting in a team approach to develop statistical and data management sections of the protocol; reviewing the final protocol for clinical, safety and efficacy variables
  • Functioning as project team member
  • Providing the project team with training on therapeutic indication and/or treatment modality
  • You may provide the study team with assistance in developing criteria for investigator site selection and networking for potential investigators for study participation, and aid in review and final selection
  • Participating in subject recruitment and retention activities which may include per sponsor request individual calls to key opinion leaders, investigators and site staff, and participation in teleconference and virtual presentations
  • Per sponsor request, presenting protocol and/or safety reporting information at investigator meetings
  • Developing project medical monitoring plan
  • Providing first line contact for investigators and monitors regarding study related medical/safety issues and resolution of study protocol and patient eligibility issues
  • Providing medical input into the development of study protocols, training materials, informed consent, Investigator Drug Brochures, analysis plan designs, clinical study reports, regulatory approval submissions
  • Providing on call coverage for protocol queries and site support

    Safety Monitoring and SAE Reporting Activities:

  • Working with the IQVIA Biotech or vendor Safety Management Department to provide medical review and case assessment of SAEs/UADEs including review and edits of SAE narratives and safety queries, follow-up on outstanding safety queries, and interacting with sponsors and investigative sites to discuss safety issues as needed
  • Per sponsor request, reviewing IND/SUSAR Safety Reports, updates to Investigator Brochures, and annual IND reports with sponsor data
  • In consultation with the sponsor, following procedures for acquiring knowledge of subject treatment assignments (i.e. breaking the blind)
  • Interacting with regulatory officials concerning safety and other study related issues, as requested

    Data Activities:
  • Providing medical review of eCRFs and edit check specifications for clinical accuracy
  • When indicated, provides Medical Data Review Plan as appendix to the Medical Monitoring Plan
  • Performing medical review of coded terms (e.g. adverse events, concomitant medications and medical history) for medical accuracy and consistency
  • Providing individual and aggregate reviews of clinical data as requested and specified in the Medical Data Review appendix
  • Reviewing laboratory data as requested by sponsor and as specified in the MMP or Medical Data Review Appendix
  • Reviewing data tables, listings, and figures as requested by sponsor
  • Reviewing and/or writes portions of final clinical study report as requested by sponsor

    Business Development Activities:
  • Working with Business Development to actively solicit new business for IQVIA Biotech, including assistance with marketing presentations and proposal development
  • Interacting with clients regarding drug development programs, study design and protocol development
  • Reviewing and providing medical and scientific input to new business proposals
  • Participating in feasibility discussions relating to specific project proposals
  • Supporting business development activities with proposal development and sales presentations

    Special Projects:
  • Obtaining literature searches to acquire background information for study proposals, preparation of training sessions, and interpretation of clinical data, report writing, etc.
  • Assisting with drafting of standard operating procedures and working practices regarding Medical Director activities
  • Participating in a variety of team quality improvement efforts as necessary
  • Performing other related duties as assigned or requested by the Vice President, Medical or designee

    Medical Management:

    • Providing management and administrative support to Medical department activities
    • Providing Line Management of assigned staff members including training, onboarding and mentoring assigned Medical department members
    • Managing staff in accordance with IQVIA Biotech’s policies and applicable regulations
    • Responsibilities include planning, assigning, and directing work; review of assigned team members’ work including Medical Monitoring Plans; appraising performance, mentoring and guiding professional development; addressing employee relations issues and resolving problems
    • Recommending course of action on management/human resources matters
    • Continually reviewing assigned staff workload and creates volume projections to ensure adequate resources are available to meet deliverables timelines and quality requirements
    • You may provide reviews and updates of Med department
    • Providing strategic input for Medical department resourcing, onboarding, and training standards
    • Providing Medical representation at Sponsor audits and Client Alignment Meetings with follow-up as necessary
    • Providing Medical input into CAPA resolution
    • Ensuring Medical activities run according to GCP and operate with highest efficiency

    Business Development Activities
  • Working with Business Development to actively solicit new business for IQVIA Biotech, including assistance with marketing presentations and proposal development
  • Supporting business development activities with proposal development and sales presentations
  • Providing medical and scientific input into new business proposals
  • Interacting with and supports IQVIA Biotech Feasibility in the development of proposals for new business, and in reassessing strategy for awarded studies
  • Participating in strategy discussions relating to specific proposals
  • Attending bid defences in a managerial capacity representing IQVIA Biotech Medical, as required
  • Attending conferences and/or meetings in support of business development opportunities

Do you meet the skills, experience and qualification requirements of the role?

  • You hold current or prior license to practice medicine, as an Infectious diseases specialist with successful completion of board certification/clinical residency.
  • You have extensive relevant Drug development and Clinical Research experience, usually demonstrated by 10 years + experience
  • You have previous medical monitoring experience.
  • You have experience within the pharmaceutical industry usually demonstrated by 3 years or more.

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at

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