We are seeking a dynamic and experienced
Senior Director, Clinical Development, who will serve as the strategic clinical lead for the advancement of our neuro-therapeutic pipeline. Reporting to the Chief Medical Officer, this role is responsible for the design, oversight, and successful execution of global clinical programs, ranging from first-in-human studies to pivotal registration trials. You will integrate scientific rigor with operational excellence to define clinical development plans (CDPs) that address the unique challenges of CNS disorders, including biomarker integration and the achievement of clinically meaningful endpoints.
Key Responsibilities- Clinical Strategy & Design: Lead the creation of innovative, science-driven Clinical Development Plans. Draft and refine high-quality protocols, investigator brochures, and clinical study reports that meet global regulatory standards.
- Trial Oversight: Provide medical and scientific leadership for ongoing Phase I-III trials, ensuring patient safety and data integrity. Collaborate closely with Clinical Operations to ensure studies remain on timeline and within budget.
- Regulatory Leadership: Act as the primary clinical representative in interactions with the FDA, EMA, and other global health authorities.
- KOL & Stakeholder Engagement: Build and maintain relationships with leading academic experts and Key Opinion Leaders (KOLs) to solicit feedback on trial design and stay ahead of the competitive landscape in neurology.
- Cross-Functional Collaboration: Partner with Clinical Operations, CMC, Regulatory Affairs and Research to ensure a seamless transition of programs from preclinical stages to clinical execution.
- Data Analysis & Interpretation: Lead the medical review of clinical trial data. Interpret trial results, including biomarker data and clinical scales-to determine go/no-go decisions for internal programs.
Qualifications & Skills- Education: MD, PhD, or PharmD in a relevant scientific field. For MD candidates, board certification in Neurology is a plus, but equivalent clinical research experience in CNS/Neurology is highly valued.
- Experience: 7+ years of experience in clinical development within the biotech or pharmaceutical industry, with a proven track record of successful IND/CTA submissions. or NDA/MAA submissions.
- Therapeutic Expertise: Deep expertise in neurological indications (e.g., neurodegeneration, pain, or neuromuscular disorders) and a thorough understanding of the current regulatory environment for neurological therapies
- Leadership: Demonstrated experience leading multidisciplinary project teams and managing external partners, such as CROs and specialty vendors.
- Strategic Mindset: Ability to translate complex scientific concepts into actionable clinical strategies that satisfy both regulatory requirements and commercial objectives.
- Exceptional leadership qualities and track record of cultivating strategic thinking, communicating clearly, possessing problem-solving skills, working independently, and building open and collaborative relationships with key stakeholders (internal and external)
- Ability to thrive in a fast-paced, entrepreneurial environment with a hands-on approach
Nura Bio offers a comprehensive and generous benefits package, including medical, dental, and vision insurance, life and disability insurance, health savings and flexible spending accounts (including dependent care), a 401(k) plan, and highly attractive stock options.
To learn more about our mission and our science, visit us at www.nurabio.com. If you have the experience we are seeking and would like the opportunity to contribute to our mission, we would like to hear from you!
