Director, Clinical Affairs

Contego Medical, LLC Located in: Raleigh,  North Carolina
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Contego Medical, LLC Biotechnology Jobs Pharmaceutical Careers
 

JOB DESCRIPTION

This position will have a leadership role in executing the company’s clinical strategy including study design, protocol development, project management and clinical trial execution in order to evaluate the safety and effectiveness of new and existing products.
Specifically, responsibilities include, but are not limited to:

  • Support development of clinical strategies
  • Design and execute global studies for regulatory submissions, reimbursement and product adoption, including clinical study documents (protocol, case report forms, etc.), study implementation and data management activities.
  • Manage study investigators, medical advisors and clinical leaders.
  • Negotiate contracts with hospitals, consultants, investigators, CROs, database management firms and outside suppliers.
  • Oversee clinical data analysis and review.
  • Other duties as assigned.

CRITICAL REQUIREMENTS

    • Medical device clinical trial management experience: 10 years
    • Cardiovascular device experience 
    • B.S. degree minimum in scientific field.
    • Working knowledge of Good Clinical Practice (GCP) and regulatory compliance guidelines for clinical trials.
    • Strong knowledge of FDA and international regulations and guidelines pertaining to clinical studies.
    • Good prioritization and organizational skills.
    • Effective written, verbal and presentation skills.

COMPANY INFORMATION

Contego Medical, LLC is a medical device company poised to disrupt the field of endovascular medicine. The Company’s Integrated Embolic Protection technology has been uniquely designed to address unmet needs in peripheral and cardiovascular procedures. The core benefit of this platform technology is the integration of embolic protection onto the same catheter as the treatment portion (i.e., balloon or stent). Contego has amassed a team of highly seasoned medical device professionals to manage this effort, led by Founder and CEO Ravish Sachar, MD, FACC. The Company is positioned for growth in a number of target markets and geographies over the next several years.

JOB INFORMATION

Seniority Level:
Director / VP
Function:
  Clinical Research / Affairs
Preferred Industry Background:
  Medical Device
Managing a team of:
N/A
Required Travel:
Moderate - 2 weeks per month

Base Salary:
90,000 To 130,000 USD PER year
Bonus:
Benefits:
Standard
Other Compensation:
Education Required:
Undergraduate
Therapeutic Experience:
Cardiovascular
Class of Device:
Class 3
International Experience:
UK / Europe,North America