Senior Medical Director
New York, NY, USA | IQVIA Holdings, Inc.
Job Description:71 people have viewed this job
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.
IQVIA Biotech , a division of IQVIA, is seeking a Senior Medical Director who is a Board Certified/Eligible Pulmonologist or Infectious Disease Specialist.
IQVIA Biotech delivers flexible, tailored, clinical and commercial solutions designed for biotech and biopharma companies. From planning, through trial design and delivery, and commercialization, IQVIA Biotech brings simplified operating procedures, specialized, therapeutically-aligned teams, and advanced data science to provide a more agile way for our customers to reach their drug development and commercialization milestones.
POSITION TITLE: Senior Medical Director
REPORTS TO: Vice President, Medical or Designee
The medical department consists of the Vice President, Medical; Senior Director, Medical Operations; Senior Directors, Medical; Senior Medical Directors and Medical Directors; Medical Data Review Directors; Medical Safety and Data Reviewers; Medical Operation Bidders; and Medical Monitor Operations Specialists.
The Senior Medical Director provides medical and scientific support to clinical research programs, study teams, and investigators.The Senior Medical Director also provides medical leadership, review, and advice for potentially or actually awarded clinical research programs. He/she also may serve as a Medical Mentor to junior staff members. The Senior Medical Director may serve as lead on special projects or assignments for the Medical Department, as requested by the VP, Medical or designee.
The Senior Medical Director role is a team member participant role and functions in a matrix and reports to project teams much like other members of project teams. The primary role of Senior Medical Director is to serve as Medical Monitor for studies conducted by IQVIA Biotech on behalf of sponsor companies. In the role of Medical Monitor, the Senior Medical Director provides medical oversight as the first line of support for clinical trials to which he/she is assigned as Medical Monitor. The principal function of a Medical Monitor is to serve as primary contact for the sponsor medical team and to serve as a medical resource to support the project team. The Medical Monitor is customarily available 24/7 to answer questions from site coordinators and investigators and study team members on protocol inclusion/exclusion criteria, protocol clarifications, and compliance issues. Major duties of the Medical Director are outlined below:
ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:
Per sponsor request, reviews and provides input for protocol development; interacts with key thought leaders and/or sponsor representatives to develop inclusion/exclusion criteria and study endpoints; interacts in a team approach to develop statistical and data management sections of the protocol; reviews the final protocol for clinical, safety and efficacy variables
Functions as project team member
Provides project team with training on therapeutic indication and/or treatment modality
May provide 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
Participates 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, presents protocol and/or safety reporting information at investigator meetings
Develops project medical monitoring plan
Provides first line contact for investigators and monitors regarding study related medical/safety issues and resolution of study protocol and patient eligibility issues
Provides medical input into the development of study protocols, training materials, informed consent, Investigator Drug Brochures, analysis plan designs, clinical study reports, regulatory approval submissions
Provides on call coverage for protocol queries and site support
Safety Monitoring and SAE Reporting Activities:
Works 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, reviews IND/SUSAR Safety Reports, updates to Investigator Brochures, and annual IND reports with sponsor data
In consultation with the sponsor, follows procedures for acquiring knowledge of subject treatment assignments (i.e. breaking the blind)
Interacts with regulatory officials concerning safety and other study related issues, as requested
Provides 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
Performs medical review of coded terms (e.g. adverse events, concomitant medications and medical history) for medical accuracy and consistency
Provides individual and aggregate review of clinical data as requested and specified in the Medical Data Review appendix
Reviews laboratory data as requested by sponsor and as specified in the MMP or Medical Data Review Appendix
Reviews data tables, listings, and figures as requested by sponsor
Reviews and/or writes portions of final clinical study report as requested by sponsor
Business Development Activities:
Works with Business Development to actively solicit new business for IQVIA Biotech, including assistance with marketing presentations and proposal development
Interacts with clients regarding drug development programs, study design and protocol development
Reviews and provides medical and scientific input to new business proposals
Participates in feasibility discussions relating to specific project proposals
Supports business development activities with proposal development and sales presentations
Obtains literature searches to acquire background information for study proposals, preparation of training sessions, and interpretation of clinical data, report writing, etc.
Assists with drafting of standard operating procedures and working practices regarding Medical Director activities
Participates in a variety of team quality improvement efforts as necessary
Performs other related duties as assigned or requested by the Vice President, Medical or designee
KNOWLEDGE, SKILLS, AND ABILITIES:
Ability to work in partnership with a multidisciplinary group of colleagues, including translating concepts into practical approaches and promoting consensus
Outstanding ability to work independently with minimal supervision, ability to work effectively within a team, and matrix environment
Ability to organize and work efficiently on several projects, each with specific requirements and/or shifting priorities
Excellent oral and written communications skills as well as interpersonal skills are essential
CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:
Ability to travel domestically and internationally as required
Very limited physical effort required to perform normal job duties
MINIMUM RECRUITMENT STANDARDS:
Current or prior license to practice medicine; board certification/eligibility ideal
10 years’ experience relevant to drug development and clinical research, including 3-5 years of biopharmaceutical industry, academic, and/or clinical practice experience
Board Certified or Eligible Pulmonologist or Infectious Disease specialist
This position is classified as exempt under the Fair Labor Standards Act; employees are not eligible for overtime compensation.
Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of 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.
Forge a career with greater purpose, make an impact, and never stop learning.
IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled
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