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MD Director Clinical Study Management

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Location
Whippanny, NJ
Salary
$200,000 - $235,000
Job Type
Direct Hire
Degree
Medical Doctor
Date
Jun 16, 2017
Job ID
2493301
Top Tier Global Pharmaceutical company is expanding and looking for two Study Medical Experts (for Clinical) must be Medical Doctor with MD degree
Can have experience in oncology or even internal medicine + endocrinology/rheumatology/gastroenterology/etc and have experience with research.
Competitive salary and benefits and bonus, 401k, long term incentives and short term incentives and more
 
  • Provide medical support for the study team:
    • Global primary contact person during the course of the study for medical/safety questions;
    • Responsible for content of medical sections of protocol/amendments;
    • Facilitate center identification and medical discussions with investigators;
    • Participate in CRO selection to ensure that the CRO staff have the requisite subspecialty experience and defines outsourced medical activities;
    • Train study team, monitors, site staff and CRO staff (if applicable) on medical aspects of the study, indication and compound;
    • Provide medical input at investigators’ meetings and presents the medical background and rationale for the trial;
    • Write the medical review plan;
    • Review patient medical data (blinded) during the course of the study to identify possible safety or data quality issues (consult with international drug safety manager, GCL and other relevant functions as needed);
    • Review medical narratives and ensures that the narratives meet an acceptable medical standard in the Clinical Study Report (CSR);
    • Give input into the EDC checks and statistical tables/listings;
    • Support the coding team for medical history, concomitant medications and adverse event codin;
    • Review the statistical tables and interprets clinical data for the CSR;
    • Responsible for the content of the medical section of the CSR.

       

  • Support the Global Clinical Development team:
    • Bring expertise on the indication studied;
    • Bring in depth knowledge about the study and its patients;
    • Help select the best countries to perform the trial;
    • Provide input into the project standards;
    • May support writing of study-related publication.

       

  • Medical point of contact regarding the trial to outside bodies:
    • Defend the trial to regulators, IRBs;
    • Prepare for DSMBs, steering committee and external consultants;
    • Able to answer and discuss in depth questions about the trial and its results.

  • Point of reference for the Country Medical contact person:
    • Provide consistent replies across the countries /regions regarding the trial both to IRBs and health authorities;
    • Help/ guide the country medical contact people in their study-specific local tasks;
    • Keep updated medical FAQ lists for the study.

       

  • Source of expert knowledge in the therapeutic area/pathology:
    • Keep up to date with scientific progress/ literature in the area;
    • Support the participating countries in their needs of medical knowledge, e.g. through training/presentations to top KOLs etc.;
    • Participate in important local/regional/global advisory boards;
    • May help prepare/ negotiate Health Authority Approvals and reimbursement.
    • This position is eligible for US Domestic Relocation

       

 

Who you are

 

Your success will be driven by your demonstration of our LIFE values.  More specifically related to this position, we seek an incumbent who possesses the following:

 

Required Qualifications:

 

  • M.D. required.  Subspecialty medical training required (Minimum 4 years postgraduate medical training);
  • Fluent in English, both written and spoken;
  • Familiar with the regulatory and legal environment;
  • Collaborative and team-oriented worker;
  • Sensitive to diverse global cultures;
  • Strong communicator for both scientific discussions and training.

 

Preferred Qualifications:

 

  • Board Certification in Oncology or other Therapeutic area
  • 1-3 years clinical training preferred.