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Vice President (VP) of Clinical Affairs

Neuroelectrics

Neuroelectrics

Boston, MA, USA
Posted on Tuesday, March 12, 2024
Who we are
Neuroelectrics is a creative, high-tech company offering the best-in-class non-invasive and high-definition electrical brain stimulation technology for personalized neuromodulation. By measuring and modifying brain function, we aim to restore brain health, minimize disabilities and create a better life for patients.
We are looking for new members of our team who already live by our shared values and are inspired by our company's Vision: Accelerate the evolution of brain science and technology by delivering advanced solutions to help end patients suffering from brain pathologies; and our Mission: Revolutionize the understanding of the brain through new personalized neuromodulation therapies, anywhere and at any time.

Position Summary
As the Vice President of Clinical Affairs, you will play a crucial role in the strategic development of our clinical research and trials. Act as the Medical Monitor of the clinical investigations, if needed. You will lead initiatives to ensure that our medical devices are clinically validated, comply with all regulatory standards, and are positioned for successful market entry. This role requires a dynamic leader with a deep understanding of the neuroscience field, medical device regulation, and the ability to navigate the complex landscape of clinical research.
What will you do

Strategic Leadership in Clinical Research:

  • Develop and implement comprehensive clinical strategies to support product development and ensure market access.

  • Lead the Clinical Evaluation Plan (design of the clinical studies) from pilot to post marketing clinical follow up

  • Oversee Clinical Evaluation Report ( EU requirement)

  • Review clinical trial protocols, and documentation for device approval (i.e IB, IFU).

  • Review third parties clinical studies proposals ( IIS- Investigator Initiated Studies)

  • Act as Medical Monitor of the clinical investigation, if needed.

Regulatory Affairs Expertise:

  • Collaborate with regulatory bodies such as the FDA, EU agencies and international counterparts.

Medical and Safety Oversight:

  • Oversee medical aspects of R&D efforts, integrating medical insights into product development.

  • Monitor participant safety, review safety management plans, and coordinate clinical safety database management.

  • Evaluate SAEs and manage clinical safety issues.

Stakeholder Engagement:

  • Represent Neuroelectrics at medical conferences and in publications.

  • Foster relationships with key opinion leaders and clinical partners.

  • Collaborate with the R&D, regulatory affairs, and marketing teams to align clinical strategies with company objectives.

Compliance and Ethics:

  • Ensure compliance with established information security and privacy policies.

  • Maintain the highest standards of ethics, safety, and compliance in all clinical activities.

What do you need
  • Medicine Degree, with specialization in neurology/ psychiatry

  • Minimum of +10 years of clinical experience, with a significant portion in a neurological and psychiatric setting.

  • At least +10 years pharmaceutical or device industry experience in clinical research role.

  • Knowledge and understanding of medical devices development and the clinical investigation process.

  • Proven track record in medical research, preferably with publications in the field of noninvasive brain stimulation or related areas.

  • Experience in a leadership role within a medical or research institution.

  • Background in developing or working with advanced model-driven methods that combine physics and physiological models.

  • Knowledge of FDA and EU Regulations and Guidance, as well as global Regulatory Standards and associated ICH Guidelines.

  • GCP certification


You will be the perfect fit if you are/have
  • Additional qualifications in neuroscience or a related research field would be advantageous.

  • Familiarity with computational neuroscience is desirable.

If you join us, you will enjoy:
  • Competitive salary in the sector (according to your experience/skills).
  • Flexible Working Hours and Hybrid work. Co-working space in Cambridge, Boston.
  • Professional development and collaborative environment.
  • Private Health insurance.
  • Unique opportunity to join our company early with excellent market traction and huge potential to grow.
About us
Neuroelectrics is a creative, high-tech company offering the best-in-class non-invasive and high-definition electrical brain stimulation technology for personalized neuromodulation. By measuring and modifying brain function, we aim to restore brain health, minimize disabilities and create a better life for patients.