Role Summary
Senior Vice President of Research & Development to join the executive leadership team and drive the next stage of Aquestive’s innovation and execution journey across all R&D functions—from late-stage discovery to early formulation and preclinical research through clinical development, regulatory approval, and commercialization. Shape and execute R&D strategy with a focus on advancing critical programs, such as shepherding Anaphylm through NDA submission and launch preparation, and progressing AQST-108 into Phase 2 trials, while fostering future pipeline opportunities. Build and mentor a high-performing R&D organization and serve as a clear, investor-facing champion for Aquestive’s scientific vision and achievements.
Responsibilities
- Develop and lead an integrated R&D strategy aligned with corporate objectives and patient-centric innovation.
- Oversee advancement of key programs including Anaphylm (epinephrine sublingual film) through NDA submission and launch, and AQST-108 (topical epinephrine) into Phase 2 trials.
- Lead all R&D functions: discovery, formulation, preclinical, clinical, regulatory, and CMC.
- Cultivate a high-performing R&D organization that emphasizes agility, innovation, and accountability.
- Drive integration of core technologies (PharmFilm and Adrenaverse) into new and existing pipeline assets.
- Serve as a cross-functional partner with Medical, Regulatory, Commercial, and Manufacturing.
- Ensure quality and compliance across all R&D activities; proactively manage risk.
- Represent Aquestive with external stakeholders including investors, partners, and scientific leaders.
Qualifications
- Ph.D. in Pharmaceutical Sciences, Chemistry, Biomedical Engineering, or related field required (M.D. with equivalent R&D leadership experience also considered).
- 15+ years in pharmaceutical/biotech R&D; 5+ years in senior leadership roles.
- Proven experience in advancing drug candidates through regulatory approval and launch.
- Expertise in non-invasive delivery systems highly desirable.
- Strong understanding of regulatory requirements (IND/NDA), clinical trial design, and CMC.
- Demonstrated ability to build and scale high-performing, cross-disciplinary R&D teams.
- Strong financial, strategic planning, and communication skills.
- Passion for innovation and a mission-driven mindset focused on patient outcomes.