Neurona Therapeutics
Medical Director / Senior Medical Director
The Senior Medical Director will guide the clinical development of cell therapy programs with a focus on epilepsy. This role involves providing strategic insights, supporting clinical trial design and data oversight, and ensuring regulatory compliance to drive medical innovation.
Key Responsibilities
- • Support the design, execution, and analysis of clinical trials, ensuring alignment with regulatory standards and scientific integrity.
- • Apply clinical expertise in epilepsy to study design, execution, and monitoring, as well as data analysis and interpretation to enhance the quality and impact of our clinical research.
- • Ensure all clinical activities comply with FDA, EMA, and other regulatory agency guidelines, maintaining high standards of quality and ethics.
- • Work closely with research, regulatory affairs, clinical operations, and other departments to drive project success.
- • Contribute to the strategic planning and execution of clinical programs, providing insights to support decision-making.
- • Oversee the collection, management, and analysis of clinical data, ensuring accuracy, consistency, and completeness.
- • Communicate effectively with internal and external stakeholders
- • Provide training and mentorship to junior staff and team members, fostering a culture of continuous learning and improvement.
- • Identify opportunities for process improvements and implement innovative solutions to enhance clinical trial efficiency and effectiveness.
- • Up to 25% travel may be required to attend study cases and conferences, meet with collaborators, and oversee clinical sites.
Required
- • MD or equivalent medical degree with completed fellowship in epilepsy or related field.
- • Relevant clinical and research experience, ideally gained during fellowship, with a focus on epilepsy.
- • Strong understanding of clinical trial design, regulatory requirements, and epidemiological research methods.
- • Excellent analytical, organizational, and communication skills, with the ability to manage multiple projects and priorities effectively.
- • Ability to work collaboratively in a fast-paced, cross-functional environment.
- • Demonstrated leadership potential and a commitment to driving medical innovation and improving patient outcomes.
- • A genuine interest in cell therapy and a commitment to advancing medical science.
Company Overview
Neurona Therapeutics is a clinical-stage biotechnology company based in South San Francisco focused on the development of allogeneic cell-based therapies for neurological diseases.
Neurona’s lead product candidate, NRTX-1001, comprising GABAergic interneurons, offers a novel approach that is not tissue-destructive for the potential treatment of drug-resistant focal epilepsy. NRTX-1001 is currently being studied for safety and efficacy in two ongoing open label multicenter, Phase 1/2 trials: NCT05135091 for drug-resistant unilateral mesial temporal lobe epilepsy (MTLE), and NCT06422923 for drug-resistant bilateral MTLE. Neurona plans to initiate the Phase 3 EPIC (EPIlepsy Cell Therapy) trial in 2H 2025. The Phase 3 EPIC trial will be for patients with drug-resistant unilateral MTLE with mesial temporal sclerosis.
Position Summary
The Senior Medical Director will play a crucial role in guiding the clinical development of our cell therapy programs. This position requires an individual with strong epilepsy expertise to provide strategic insights, support clinical trial design and data oversight, and ensure regulatory compliance. The ideal candidate will have a solid foundation in clinical epilepsy care and research and a keen interest in driving medical innovation.
Position Duties And Responsibilities
Neurona is proud to be an equal opportunity employer and will consider all qualified applicants for employment.
Recruitment Fraud Notice
We are aware of active recruitment scams using the Neurona name, where individuals pose as our recruiters or post fake remote job openings and make fraudulent job offers online. Please note, that we will never make an offer of employment without conducting multiple rounds of face-to-face interviews using secure video-conferencing technology. Additionally, we will never ask candidates to cash checks or make any payment to be considered for a position.
If you believe you have been a victim of a phishing scam, please visit the Cybersecurity & Infrastructure Security Agency (CISA) at https://www.cisa.gov/be-cyber-smart/report-incident to learn how to report it.
Neurona Therapeutics is a clinical-stage biotechnology company based in South San Francisco focused on the development of allogeneic cell-based therapies for neurological diseases.
Neurona’s lead product candidate, NRTX-1001, comprising GABAergic interneurons, offers a novel approach that is not tissue-destructive for the potential treatment of drug-resistant focal epilepsy. NRTX-1001 is currently being studied for safety and efficacy in two ongoing open label multicenter, Phase 1/2 trials: NCT05135091 for drug-resistant unilateral mesial temporal lobe epilepsy (MTLE), and NCT06422923 for drug-resistant bilateral MTLE. Neurona plans to initiate the Phase 3 EPIC (EPIlepsy Cell Therapy) trial in 2H 2025. The Phase 3 EPIC trial will be for patients with drug-resistant unilateral MTLE with mesial temporal sclerosis.
Position Summary
The Senior Medical Director will play a crucial role in guiding the clinical development of our cell therapy programs. This position requires an individual with strong epilepsy expertise to provide strategic insights, support clinical trial design and data oversight, and ensure regulatory compliance. The ideal candidate will have a solid foundation in clinical epilepsy care and research and a keen interest in driving medical innovation.
Position Duties And Responsibilities
- Clinical Development Leadership: Support the design, execution, and analysis of clinical trials, ensuring alignment with regulatory standards and scientific integrity.
- Epilepsy Expertise: Apply clinical expertise in epilepsy to study design, execution, and monitoring, as well as data analysis and interpretation to enhance the quality and impact of our clinical research.
- Regulatory Compliance: Ensure all clinical activities comply with FDA, EMA, and other regulatory agency guidelines, maintaining high standards of quality and ethics.
- Cross-functional Collaboration: Work closely with research, regulatory affairs, clinical operations, and other departments to drive project success.
- Strategic Planning: Contribute to the strategic planning and execution of clinical programs, providing insights to support decision-making.
- Data Management: Oversee the collection, management, and analysis of clinical data, ensuring accuracy, consistency, and completeness.
- Stakeholder Communication: Communicate effectively with internal and external stakeholders
- Training and Mentorship: Provide training and mentorship to junior staff and team members, fostering a culture of continuous learning and improvement.
- Innovation and Improvement: Identify opportunities for process improvements and implement innovative solutions to enhance clinical trial efficiency and effectiveness.
- Travel: Up to 25% travel may be required to attend study cases and conferences, meet with collaborators, and oversee clinical sites.
- Education: MD or equivalent medical degree with completed fellowship in epilepsy or related field.
- Experience: Relevant clinical and research experience, ideally gained during fellowship, with a focus on epilepsy.
- Knowledge: Strong understanding of clinical trial design, regulatory requirements, and epidemiological research methods.
- Skills: Excellent analytical, organizational, and communication skills, with the ability to manage multiple projects and priorities effectively.
- Collaboration: Ability to work collaboratively in a fast-paced, cross-functional environment.
- Leadership: Demonstrated leadership potential and a commitment to driving medical innovation and improving patient outcomes.
- Passion: A genuine interest in cell therapy and a commitment to advancing medical science.
Neurona is proud to be an equal opportunity employer and will consider all qualified applicants for employment.
Recruitment Fraud Notice
We are aware of active recruitment scams using the Neurona name, where individuals pose as our recruiters or post fake remote job openings and make fraudulent job offers online. Please note, that we will never make an offer of employment without conducting multiple rounds of face-to-face interviews using secure video-conferencing technology. Additionally, we will never ask candidates to cash checks or make any payment to be considered for a position.
If you believe you have been a victim of a phishing scam, please visit the Cybersecurity & Infrastructure Security Agency (CISA) at https://www.cisa.gov/be-cyber-smart/report-incident to learn how to report it.
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