Haemonetics
Published
January 11, 2022
Location
Boston, MA
Category
Other  
Job Type
Work Setting
Remote / Home-based, In-office

Description

We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further — Haemonetics is your employer of choice.


Job Details

Provide medical advice and oversight to the portfolio of clinical development projects for Hospital products with focus on Vascade (Class III, vascular closure device) as well as TEG and ClotPro (IVD), as well as to medical safety assessments for this portfolio

Design medical strategy and clinical development plans for key products and projects in close coordination with cross-functional partners (e.g., Clinical Development, Medical Affairs, R&D, Marketing, Regulatory, Clinical Quality); author (as needed) and review/approve clinical protocols and reports, support documentation for regulatory submissions and filings

Provide medical oversight of clinical trial execution, conduct required medical monitoring, and work with sites as well as third-party providers, such as CROs, statisticians, etc., as needed and in partnership with Clinical Development and Medical Affairs.

Author (as needed) and/or review/approve statistical analysis plans; review and contribute to the interpretation of clinical trial data; conduct (as needed) and/or review/approve statistical analyses; author (as needed) and/or review/approve Clinical Study Reports (CSR)

Present clinical plans, protocols, results, etc. to U.S. FDA or other regulatory authorities, as required

Represent the Hospital portfolio externally related to new product innovation (NPI) and Clinical Development

Support Clinical Development in building a reliable network of high-quality sites and investigators (focus on cardiology, interventional cardiology, electrophysiology)

Actively engage with the clinical and scientific community to gain insights into our products and their potential use to inform clinical trial design; conduct advisory board meetings as needed
Represent clinical development programs at national and international scientific conferences, as appropriate

Collaborate closely with the business to align priorities, develop project concepts and to quantify opportunities

Ensure compliance of Haemonetics clinical development efforts with all applicable regulations

Requirements

Education:

  • Bachelor’s Degree preferably B.S.
  • Master’s Degree preferably in life sciences
  • Advanced degree    M.D. (preferred) or Ph.D. in life sciences required

Experience:

  • 10 years minimum clinical and academic experience in relevant roles required (someone that has practiced medicine in the area and made the transition into the industry)
  • 5 years minimum (additional) Industry experience in Medical/Clinical leadership roles required
  • Industry experience Medical Devices or Pharma preferred
  • Industry experience In vitro diagnostics (IVD) or Vascular Closure preferred
  • Therapeutic area experience Coagulation, Cardiology, Interventional Cardiology, Electrophysiology preferred

Travel:

  • 30% Travel (including overnight, primarily domestic US travel)

 

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