
Director of Early Development
1 day ago
Nasus Pharma is a clinical-stage pharmaceutical company developing a number of intranasal powder products addressing acute medical conditions in the community. Nasus proprietary powder-based intranasal ("PBI") technology is designed for rapid and reliable drug delivery, leveraging the nasal cavity's rich vascular network for quick absorption.
Nasus Pharma is seeking a Director of Early Development that will lead the design, execution, and interpretation of nonclinical and early clinical studies. This cross-functional role will partner closely with internal and external stakeholders to ensure seamless progression of assets from preclinical through Phase 1 development, while also contributing to regulatory strategy and documentation.
Responsibilities
:
- Design and oversee execution of GLP and non-GLP pharmacology, PK/PD, and toxicology studies
- Interface with CROs, external consultants, and internal R&D teams to manage timelines, budgets, and deliverables
- Ensure studies are conducted in compliance with ICH/GLP guidelines and are suitable for regulatory filings
- Design and develop Phase I clinical protocols including FIH, SAD/MAD, PK, and bioavailability studies
- Lead authoring and review of clinical study documents (protocols, IBs, ICFs, etc.)
- Collaborate with clinical operations on site selection, study startup, and conduct
- Contribute to IND/CTA submissions, including nonclinical and clinical sections
Qualifications
- At least MSc in pharmacology, pharmaceutical sciences, Biochemistry, Biology or a related life sciences discipline. PhD is an advantage.
- Minimum 4 years of experience in biotech or pharma R&D, including direct leadership of nonclinical and/or early clinical development programs
- Proven experience designing and executing nonclinical safety and pharmacology studies (GLP and non-GLP)
- Demonstrated ability to design and interpret Phase 1 clinical trials, including bioavailability/bioequivalence assessments
- Strong understanding of regulatory requirements (FDA, EMA) for IND-enabling studies
- Excellent scientific writing and communication skills
- Ability to manage multiple priorities in a fast-paced, entrepreneurial environment
- Excellent communication skills and the ability to collaborate with cross-functional teams
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