Associate VP / VP of Clinical Development

AcuraStem is a patient-based biotechnology company pioneering the development of treatments for amyotrophic lateral sclerosis (ALS), Frontotemporal dementia (FTD), and additional neurodegenerative diseases. We are a purpose-driven company on a mission to get our promising treatments into patients' hands as quickly as possible.

AcuraStem’s best-in-class disease modeling platform, iNeuroRx®, is the gold standard for discovering novel, effective, and broadly-acting treatments. The AcuraStem team’s extensive expertise in ASO technology is accelerating the advancement of treatments to the clinic.

At AcuraStem, we know that empowered and supported colleagues strengthen our commitment and significantly enhance our collective mission. We're dedicated to fostering a culture of equality, inclusion, and mutual respect. By creating an environment where everyone feels valued and motivated to excel, we can achieve exceptional outcomes, together.

Position Overview:

We are seeking a highly experienced and strategic Vice President, Clinical Development – Neuroscience to lead the clinical strategy and execution of our neuroscience programs. The VP will oversee clinical development plans from early-stage clinical trials through late-stage development, ensuring regulatory alignment and successful clinical execution. This role requires a deep understanding in conducting neurodegenerative disease clinical trials, translational sciences, and regulatory frameworks.

Key Responsibilities:

• Lead the clinical development strategy for AcuraStem’s neuroscience programs, ensuring alignment with corporate objectives.
• Oversee the design, execution, and analysis of clinical trials, from first-in-human studies through registrational trials.
• Provide clinical and scientific leadership to cross-functional teams, including research, regulatory, and external partners.
• Collaborate with key stakeholders, including regulatory agencies, key opinion leaders (KOLs), patient advocacy groups, and external partners.
• Ensure compliance with FDA, EMA, and other global regulatory requirements, guiding regulatory interactions and submissions.
• Identify and mitigate risks in clinical development plans, ensuring data integrity and operational excellence.
• Represent AcuraStem at scientific and medical conferences, fostering partnerships and increasing visibility in the neuroscience community.
• Drive the clinical development team’s growth, mentoring staff and fostering a culture of innovation and excellence.

Desired Skills and Experience:

• MD, PhD, or MD/PhD with a strong background in neuroscience, neurology, or a related field.
• 10 years of experience in clinical development, with a focus on neurodegenerative diseases.
• Proven track record of leading clinical programs from Phase 1 through regulatory approval.
• Deep knowledge of neurodegenerative disease mechanisms, biomarkers, and translational research. Experience with ALS is a plus.
• Strong understanding of regulatory pathways for neuroscience drug development, including interactions with FDA and EMA.
• Excellent leadership, communication, and strategic thinking skills.
• Ability to thrive in a fast-paced, early-stage biotech environment with a hands-on approach.
• Experience managing external partnerships, CROs, and academic collaborations.

Compensation/Benefits:

• The salary range for this position is $200,000 - $300,000 with actual compensation determined by factors such as experience, qualifications, location, and other role-specific requirements.
• AcuraStem offers a comprehensive and competitive benefits package tailored to attract top talent. All regular-status employees receive compensation, performance-based bonuses, equity, and extensive benefits, including health, dental, vision, life, and disability insurance. AcuraStem also provides paid time off, annual company holidays, 401K matching, and weekly lunch for onsite staff.

Diversity, Inclusion, and Recruitment Practices at AcuraStem:

• Applicants must be authorized to work in the United States. AcuraStem is an equal-opportunity employer and values diversity and inclusion throughout the hiring process. Employment decisions are made based on relevant qualifications, experience, and business needs, without regard to race, color, religion, sex, gender identity, sexual orientation, age, marital status, national origin, disability, veteran status, or any other protected characteristic.
• AcuraStem’s commitment to diversity and inclusion extends to all areas of employment, including hiring, compensation, performance evaluations, promotions, training, and career development. We strive to provide a supportive and inclusive workplace, free from discrimination or harassment.
• For staffing inquiries, AcuraStem’s Human Resources team manages all recruitment activities directly. We ask that external recruiters avoid contacting hiring managers or submitting candidates without prior authorization, as unsolicited resumes will not establish any contractual relationship with AcuraStem