Chief Medical Officer

Company Overview:

With a mission to conquer brain disorders, Neural Galaxy Inc. is a pioneering brain science company committed to revolutionizing the treatment of brain disorders through innovative therapeutic solutions. We harness recent advancement of brain function networks and cloud computing to address a wide range of neurological conditions, offering new hope for patients and transforming the field of brain health. Backed by institutional investors with over $100M in funding, we are seeking an accomplished and visionary Chief Medical Officer (CMO) to lead our clinical and regulatory endeavors and drive the development of life-changing therapies.

Position Overview:

As the Chief Medical Officer, you will play a pivotal role in shaping the medical strategy, clinical direction, and regulatory affairs. Reporting directly to the CEO, you will lead the regulatory affairs and clinical development teams to ensure the safety, efficacy, and regulatory compliance of our groundbreaking therapeutic product and services. Your expertise will guide the successful translation of scientific discoveries into meaningful treatments for patients worldwide. This position is based at our Cambridge headquarter in Massachusetts.

Key Responsibilities:

1. Medical Strategy and Leadership

Develop and execute the medical and clinical strategy aligned with the company's mission and business objectives. Provide medical leadership and direction to cross-functional teams, ensuring alignment between scientific research, clinical development, and commercialization efforts. Drive the identification of new therapeutic targets and opportunities based on neuroscience advancements.

2. Clinical Development

Oversee the design, implementation, and management of clinical trials to evaluate the safety and efficacy of our therapeutic solutions. Collaborate with research scientists, engineers, and regulatory experts to ensure rigorous study design and data collection. Interpret and analyze clinical trial results to inform decision-making and support product development.

3. Regulatory Compliance and Affairs

Lead interactions with regulatory authorities to secure approvals for clinical trials and commercialization of therapeutic solutions. Provide medical and clinical expertise for regulatory submissions, including Investigational Device Exemptions (IDEs), Pre-Market Approvals (PMAs), and global submissions.

4. KOL Engagement and Stakeholder Management

Cultivate relationships with key opinion leaders (KOLs), neuroscience experts, and medical professionals to gain insights, support clinical research, and establish the company's credibility. Collaborate with patient advocacy groups, professional societies, and regulatory agencies to ensure alignment with medical and clinical objectives.

5. Safety and Risk Management:

Develop and implement risk management strategies, including post-market surveillance and adverse event reporting, to ensure patient safety and regulatory compliance. Monitor real-world data and collaborate with the post-market surveillance team to address safety concerns promptly.

Qualifications:

1. Medical Doctor (MD) degree with board certification in a relevant neurology, psychiatry, radiology, or neuroscience specialty; advanced degree (MD/Ph.D.) preferred.

2. Extensive experience in medical affairs, clinical development, and regulatory affairs within the medical device or biotechnology industry, with a focus on brain-related disorders.

3. Deep understanding of global regulatory requirements for medical devices and therapeutics, including FDA regulations and international standards.

4. Proven ability to lead the development of medical and clinical strategies that align with scientific innovation.

5. Strong interpersonal and communication skills to collaborate with KOLs, researchers, healthcare professionals, and regulatory agencies.

6. Previous leadership experience managing cross-functional teams and fostering a collaborative and innovative culture.

Join Neural Galaxy in our mission to conquer brain disorders! To apply, please submit your resume and a cover letter outlining your relevant experience and your vision for advancing brain science therapies at cmo@neuralgalaxy.com.

Neural Galaxy is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.