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Senior Medical Director, Oncology (Homebased - UK/Europe) - IQVIA Biotech

Employer
IQVIA Biotech
Location
Homeworking
Salary
Excellent Salary + Benefits and Bonus
Start date
2 Aug 2019
Closing date
1 Sep 2019

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Job Details

IQVIA Biotech is looking for a leader and outstanding Senior Medical Director to join the expanding Medical Department. IQVIA Biotech continues to grow and acquire studies representing new and cutting-edge therapeutic modalities in multiple therapeutic arenas. For this reason, we need experts to bolster the already accomplished group of Medical Directors 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 IQVIA Biotech , 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 Oncologist
  • Minimum 3-5 years of biopharmaceutical industry experience in drug development and clinical research or academic medicine

Company

IQVIA Biotech is the global, enterprise-wide solution that provides flexible, tailored, integrated clinical and commercial solutions to small biotech and pharmaceutical companies, from planning through trial design and implementation to launch and commercialization.

We recognize that the needs of small companies are different than large companies, so we developed a separate business unit within IQVIA which provides a high-touch solution with high levels of service and hands-on attention, with the benefits of IQVIA’s data and expertise – including powerful analytics, resources, therapeutic experts and global footprint.

IQVIA Biotech has five therapeutic divisions. Complementing our successful history in Oncology, we have dedicated delivery teams in General Medicine – which includes Dermatology, Cardiovascular/Renal/Metabolics, Central Nervous System and Immunology.

Interested in being a part of this exciting and dynamic team?

Contact us today to find out more!

 

Company info
Website
Telephone
+44(0)1438 221122
Location
Ground Floor
Abel Smith House
Gunnells Wood Road
Stevenage
Herts
SG1 2ST
United Kingdom

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