Sr. Medical Director, Clinical Development
Description
Cornerstone Search Group has been retained by an attractive and well-funded clinical-stage biotech company focused on developing cutting-edge next-generation therapies in the neuroscience area. This is an exciting time within the organization as they are progressing forward in development, and you would be joining a company with significant upside potential and at the forefront of neuroscience innovation. This is an opportunity to be part of something very unique with a company working to shape the future of neuropsychiatric treatments for a variety of mental health disorders. Given the smaller company environment, our client is seeking someone who is flexible, works well cross-functionally (collaborative mindset), and embraces the small startup hands-on biotech culture.
Features
ATTRACTIVE FEATURES OF THIS POSITION AND COMPANY:
- Impact & Visibility: This is a newly-created role where you will report to the CMO and have a visible impact on the company’s success and strategic evolution.
- Exciting Company & Upside Potential: Our client has been highlighted in several publications as one of the most promising young biotech companies in the neuroscience space. You will be joining a company that is very well-funded and rapidly ascending and working to shape the future of neuropsychiatric treatments.
- Innovative Neuropsychiatric Compounds: Your work will focus on exciting, potentially transformative, next-generation therapies for a variety of mental health disorders.
- Small/Startup Biotech Culture: The company offers all the attractive features sought with a smaller, fast-paced biotech company (autonomy, small team camaraderie, high-impact, agility, minimal layers/bureaucracy), which fosters more collaboration, communication, and swifter decision-making (i.e. emphasis on progress and moving things forward).
- Join a Fantastic Team: You will be part of a top-notch clinical group and work closely with an industry-experienced and accomplished Executive Leadership team.
Responsibilities
- This role encompasses responsibilities such as providing medical and scientific expertise for ongoing clinical studies, contributing to clinical development strategies, leading protocol development, providing leadership to CRO medical monitors, and managing regulatory interactions with the FDA and other international bodies.
- Contribute to the broader clinical-development strategy for the company’s clinical programs, supporting data integrity, protocol innovation, site engagement, and scientific communication.
- Partner with the Clinical team members on strategic planning for the company’s programs, including clinical design, regulatory strategy, and long-term indication expansion. Ongoing responsibility for data accrual and quality, ensuring clinical trial integrity and consistency across studies.
- Lead and support protocol development, amendments, and study-specific medical training.
- Participate in the development and review of clinical study reports, data summaries, and regulatory submissions.
- Contribute to FDA and international regulatory interactions, including briefings, responses, and data presentations
- Engage with KOLs, investigators, and professional organizations to communicate the company’s clinical vision and scientific advances.
Qualifications / Requirements
DESIRED BACKGROUND & EXPERIENCE:
- Medical Degree is required; specialty in psychiatry, neurology, or related area is preferred.
- 5+ years of relevant clinical development experience gained working at a pharmaceutical or biotech company.
- Demonstrated leadership on Phase 2 and/or Phase 3 studies — ideally within neurology, psychiatric, or psychedelic-based drug development.
- Proven ability to work effectively in a fast-paced entrepreneurial environment, to be self-motivated, and to communicate effectively with leadership on-site and internally.
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