Senior Medical Director, Biopharma (Home-Based, UK/Europe) - IQVIA Biotech (R1102862) in Stevenage, UK at IQVIA™

Date Posted: 11/22/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Stevenage, UK
  • Experience:
    Not Specified
  • Date Posted:
    11/22/2019
  • Job ID:
    R1102862

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.

POSITION TITLE:                       (Senior) Medical Director             

REPORTS TO:                                VP, Medical IQVIA Biotech

BASIC FUNCTIONS:

The (Senior) Medical Director provides senior medical, clinical and scientific advisory expertise to IQVIA Biotech divisions.

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.  As such, the (Senior) Medical Director 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) Medical Director serves as a medical expert throughout business development activities by developing and supporting the medical strategy by providing review, advice, and leadership for potentially or actually awarded clinical research programs. Additionally, the (Senior) Medical Director provides medical and scientific support to clinical research programs, study teams and investigators.  

The (Senior) Medical Director is a team member participant role and functions in a matrix report to project teams much like other members of the project teams.  The primary role of (Senior) 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 Medical Monitor is customarily available 24/7 to answer questions from site coordinators and investigators on protocol inclusion/exclusion criteria, protocol clarifications, and compliance issues, and to provide review of alert labs per sponsor preference.

Major duties of the (Senior) Medical Director are outlined below:

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

Medical Monitoring:

Clinical Activities:

  • Participates in pre-award activities to support the acquisition of new business including working with Feasibility team members.
  • Provides medical or scientific input into new business proposals.
  • Attends and presents at bid defenses.
  • Provides expert medical guidance for protocol or program development.
  • Serves as Medical Monitor for awarded studies.
  • Assists team with developing criteria for investigator site selection and networking for potential investigators for study participation.  Aids in review and final selection as requested.
  • 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/Skype presentations as requested.
  • 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.
  • Provides medically focused regulatory guidance and input re: regulatory submissions.
  • Provides guidance to study team members and sponsors on the medical and scientific aspects of assigned projects. 
  • Provides first line contact for investigators and monitors regarding study related medical/safety issues and resolution of study protocol and patient eligibility issues for assigned studies.
  • Serves as first point of escalation for the project team and sponsor for medically related matters of awarded work.
  • Attends Kick-Off meetings and internal team and client meetings for assigned studies.
  • Provides project team training on protocol and/or therapeutic areas.
  • Develops project medical monitoring plans
  • Attends and presents at Investigator Meetings for assigned studies. 
  • Provides medical and scientific input to study protocols, training materials, informed consent, Investigator Drug Brochures, eCRFs, analysis plan designs, clinical study reports, regulatory approval submissions, serious and non-serious adverse event evaluation and reporting as requested.
  • Serves as Medical Safety Reviewer and/or Medical Data Reviewer for assigned studies as requested.
  • Available 24 hours per day, 7 days per week to respond to urgent protocol-related issues at the investigative sites for assigned studies.

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 including review and edits of SAE narratives and safety queries, follow-up on outstanding safety queries, and interacting with sponsors and sites to discuss safety issues with site as needed.  
  • Reviews IND/SUSAR Safety Reports (per sponsor preference), provide updates to Investigator Brochures, and annual IND reports with sponsor data as requested.
  • In consultation with the sponsor, follows procedures for acquiring knowledge of subject treatment assignments (i.e. breaking the blind) as requested.
  • Interacts with appropriate FDA officials concerning safety and other study related issues, as requested.

Data Activities:

  • Provides input into and guidance and review of work of the Medical Data Review Director and team members.
  • Provides medical input into the development of eCRFs and edit check specifications for medical accuracy as requested.
  • Reviews medical coding of adverse events, medical history and con meds for medical accuracy and consistency as requested.
  • Reviews adverse events, laboratory data and concomitant medications and other sponsor requested data points for accuracy, coherence, consistency, and trends as requested.
  • Provides medical review of the data analysis plan.
  • Reviews safety fields at case freeze for reconciliation as requested.
  • Works with the safety and data groups to reconcile SAE events as requested.
  • Reviews data tables, listings, and figures as requested.
  • Reviews and/or writes portions of final clinical study report as requested.

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
  • Minimum 3-5 years of biopharmaceutical industry experience or academic experience in clinical research and drug development

CLASSIFICATION:

This position is classified as exempt under the Fair Labor Standards Act; employees are not eligible for overtime compensation.

EU: N/A

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.



Job ID: R1102862