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Director of Clinical Affairs - Med Device

Job Description

Director of Clinical Affairs

We are currently seeking a Head of Clinical Affairs for Corindus.   Corindus Vascular Robotics, Inc. is a global technology leader in robotic-assisted vascular interventions. The company's CorPath® system is the first FDA-cleared medical device to bring robotic-assisted precision to percutaneous coronary and peripheral interventions. Corindus is advancing the field of interventional medicine with robotics through improvements to procedural control, precision, and workflow.  Located in Waltham, MA, the position is an individual contributor role and will report to the Head of Neurovascular & Clinical Affairs. 

Responsibilities

  • Identifies clinical sites and establishes relationships with potential Principal Investigators.
  • Work directly with customers to validate the clinical value of the product (work on on-going trials and initiate trials with customer)
  • Support clinical research-related procedures
  • Develops Protocols and IRB submissions, obtains the necessary approvals
  • Ensures study implementation, including site staff training, data collection, and oversees study progress
  • Performs data analysis, generates reports, and archives data
  • Provide feedback to product management for User Requirements generation and validation based on interfacing with clinical users
  • Create and tracks clinicals study plans and budgets
  • Ensures compliance with regulations (e.g. FDA, ISO, ICH)
  • Integrity and trust, drive for results, building effective teams, action-oriented
  • Solid understanding of the industry
  • Proven ability to directly lead and/or co-lead multiple high-impact process improvement projects
  • Strong strategic thinker
  • Proven ability to coach and mentor others
  • Excellent interpersonal and communication skills, including proven verbal, written, and presentation skills. Ability to communicate complex information in a clear, concise manner
  • Experience working in cross-functional teams in a highly matrixed organization
  • Proven ability to cultivate an active network of relationships within and outside of the organization

Required Knowledge/Skills, Education, and Experience

•         Bachelor’s degree required with a minimum of ­­10+ years of experience Medical Device and/or Neuro/cardio vascular industry.  Program/project management and/or process improvement in clinical research or healthcare industry or advanced degree with a minimum of ­5 years of experience in program/project management and/or process improvement in clinical research or healthcare industry

  • Project Management Professional (PMP), Certification as a Lean Six Sigma Black Belt; PMP/RMP certification; Project Management Certification (preferably PMI) and/or Green Belt Certification.
  • Experience working on a Global study team
  • Experience in managing clinical trial data review and multiple clinical research sites with proven results in study execution
  • Comprehension and understanding of Clinical affairs functional systems and processes
  • Working knowledge of FDA and ISO regulations
  • Basic understanding of biostatistics and trial design
  • Experience in MS Project (or similar scheduling software), project management techniques and tools, Excel, PowerPoint and Word.
  • Expertise in both theoretical and practical aspects of project management.
  • Excellent interpersonal and communication skills, including proven verbal, written, and presentation skills. Ability to communicate complex information in a clear, concise manner
  • Experience working in cross-functional teams in a highly matrixed organization
  • Proven ability to cultivate an active network of relationships within and outside of the organization

• Travel approximately 10% of the time.



Organization: Siemens Healthineers

Company: Corindus, Inc.

Experience Level: Experienced Professional

Job Type: Full-time



Equal Employment Opportunity Statement
Siemens is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law.

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