Senior Medical Director, Oncology (Home-Based) - IQVIA Biotech (R1084809) in Morrisville, NC at IQVIA™

发布日期: 8/20/2019

职位快速浏览

  • 员工类型:
    Full-Time
  • 经验:
    Not Specified
  • 发布日期:
    8/20/2019
  • Job ID:
    R1084809

职位描述

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 is looking for a leader and outstanding Senior Medical Director to join the expanding Medical Department. Oncology is a cornerstone of IQVIA Biotech as we continue to grow and acquire studies representing new and cutting-edge therapeutic modalities in this arena. For this reason, we need experts to bolster the already accomplished group of Oncologists within IQVIA Biotech's Medical Department.

The primary role of the Medical Director is to provide medical oversight for clinical trials by serving as Medical Monitor for studies conducted by IQVIA Biotech on behalf of sponsor companies. The principal function of a Medical Monitor is to serve as primary contact for the sponsor medical team and to serve as front line medical resource to support the project team. The IQVIA Biotech Medical Monitor also works as Medical Safety Reviewer in conjunction with IQVIA Biotech Safety Management, and provides Medical Data Review in support of Data Management. The IQVIA Biotech Medical Director also provides support for the acquisition of new business by participation in the bid defense process with medical review of proposal text, and by preparing for and attending bid defenses.

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

  • Provides medical and scientific input to clinical research programs including review of new business proposals, preclinical and/or clinical data, study protocols, training materials, informed consent, Investigator Drug Brochures, eCRF design, analysis plan designs, clinical study reports, regulatory approval submissions, serious and non-serious adverse event evaluation and reporting
  • Ensures medical activities run according to GCP and operate with highest efficiency
  • Establishes and maintains a network of medical/scientific consultants, etc.
  • Supervises and manages Medical Director activities

Clinical Activities:

  • Interacts with clients regarding drug development programs, study design and protocol
  • 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 team approach to develop statistical and data management sections of the protocol.  Reviews the final protocol for clinical, safety and efficacy variables as requested.
  • Provides project team training on protocol and/or therapeutic areas
  • Assists team with developing criteria for investigator site selection and networking for potential investigators for study participation.  Aids in review and final selection.
  • Participates in subject recruitment and retention activities including individual calls to key opinion leaders, investigators and site staff and/or participation in teleconference and WebEx presentations
  • Presents protocol and/or safety reporting information at investigator meetings
  • Provides first line contact for investigators and monitors regarding study related medical/safety issues and resolution of study protocol and patient eligibility issues.
  • Provides on call coverage for protocol queries and site support. 
  • Develops project medical monitoring plan

Safety Monitoring and SAE Reporting Activities:

  • Provides medical review of SAE reporting, writes and/or reviews SAE narratives, and works with the Safety Management Department to track SAEs and follow-up on outstanding safety queries, interacts with sponsor and discusses safety issues with site as needed  
  • Verifies the medical accuracy of patient safety data and maintains an ongoing assessment of the safety profile of the study per sponsor preference
  • Reviews IND/SUSAR Safety Reports (per sponsor preference), updates to Investigator Brochures, and annual IND reports with sponsor data
  • In consultation with the sponsor, follow procedures for acquiring knowledge of subject treatment assignments (i.e. breaking the blind)
  • Interact with appropriate FDA officials concerning safety and other study related issues, as requested

Data Activities:

  • Provides medical input in development of eCRFs for clinical accuracy
  • Provides medical review of data analysis plan
  • Reviews medical coding of adverse events, laboratory data and concomitant medications for accuracy, coherence, consistency, and trends
  • Reviews data tables, listings, and figures
  • Reviews safety fields at case freeze for reconciliation (if needed)
  • Works with data group to reconcile SAE events as needed
  • Reviews and/or writes portions of final clinical study report if requested

Business Development Activities

  • Work with Business Development to actively solicit new business for Novella Clinical, including assistance with marketing presentations and proposal development
  • Supports business development activities with proposal development and sales presentations
  • Participates in feasibility discussions relating to specific project proposals

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:

  • Licensed M.D.; board certification/eligibility ideal
  • Minimum 3-5 years of biopharmaceutical industry experience in drug development and clinical research or academic medicine

Join Us

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

IQVIA, Inc. provides reasonable accommodations for applicants with disabilities.  Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.



Job ID: R1084809