Head of Research

Head of Research (Translational & Combination Products)

Overview

The Head of Research will lead translational research for a novel ingestible drug-device platform designed for oral delivery of existing drug molecules. This role oversees generation of high-quality preclinical, formulation, and CMC data to support device development, regulatory strategy, and external collaborations.

The position provides strategic and operational leadership across preclinical research, formulation, and CMC activities, while managing external partners, timelines, and data quality. The ideal candidate brings deep expertise in large molecule drug development and experience working at the interface of drug and device development.

Key Responsibilities

Translational Research

• Lead preclinical research programs with a focus on safety, pharmacology, and translational relevance.
• Design and oversee in vivo studies aligned with development objectives.
• Analyze and present preclinical data to internal teams and external collaborators.
• Ensure studies meet GxP standards and scientific best practices.
• Oversee the CMC team

Oversee the CMC team

Oversee the CMC team which will be responsible for:

• Lead formulation and CMC activities for large molecule drug products delivered through an ingestible device platform.
• Oversee formulation optimization, stability, and degradation studies to support combination product performance.
• Support technology transfer to CDMOs and GMP manufacturing readiness.
• Partner with Quality and Regulatory teams to support CMC components of regulatory submissions.

Drug–Device Combination Development

• Provide scientific oversight of drug-device interaction studies and analytical characterization.
• Contribute to development strategies for combination products in line with regulatory expectations.

External Partnerships & Leadership

• Select and manage CROs, CDMOs, and other external partners.
• Contribute to data packages for partnerships, diligence, and external presentations.
• Lead preparation of scientific and regulatory documentation.
• Build and mentor high-performing research teams.

Qualifications

Education

• PhD preferred, open to candidates with MS and extensive experience

Experience

• ~15+ years of experience in translational, preclinical drug development.
• Strong background in biologics or large molecule drug development through preclinical and early clinical stages.
• Experience with oral or device-enabled delivery approaches preferred.
• Familiarity with IND-enabling activities and regulatory submissions.
• Experience in fast-paced biotech or startup environments desirable.