Head of Research
187505
Posted: 04/03/2026
- $300,000.00
- San Diego United States
Head of Research (Novel Ingestible Drug-Device Platform)
Location: San Diego, CA (Startup Environment)
Position Type: Full-time, Executive Leadership
Company Overview
We are a pioneering, venture-backed biotechnology company transforming therapeutic delivery. Our innovative platform uses proprietary smart capsule technology to enable oral delivery of large molecule biotherapeutics (including monoclonal antibodies, peptides, and nucleic acids) directly to the GI tract. We are revolutionizing patient care by transforming high-value injections into patient-friendly oral, needle-free, drug-device combination products.
Position Summary
We are seeking a seasoned, strategic, and hands-on Head of Research to lead translational research activities, focusing on the formulation and CMC development of our novel ingestible device platform. Reporting directly to executive leadership, you will play a pivotal role in driving preclinical, formulation, and drug CMC data generation to support device development, regulatory submissions, and key alliance management. This role requires a unique blend of expertise in large-molecule drug development, CMC, and the ability to operate at the intersection of drug and device in a fast-paced environment.
Key Responsibilities
Location: San Diego, CA (Startup Environment)
Position Type: Full-time, Executive Leadership
Company Overview
We are a pioneering, venture-backed biotechnology company transforming therapeutic delivery. Our innovative platform uses proprietary smart capsule technology to enable oral delivery of large molecule biotherapeutics (including monoclonal antibodies, peptides, and nucleic acids) directly to the GI tract. We are revolutionizing patient care by transforming high-value injections into patient-friendly oral, needle-free, drug-device combination products.
Position Summary
We are seeking a seasoned, strategic, and hands-on Head of Research to lead translational research activities, focusing on the formulation and CMC development of our novel ingestible device platform. Reporting directly to executive leadership, you will play a pivotal role in driving preclinical, formulation, and drug CMC data generation to support device development, regulatory submissions, and key alliance management. This role requires a unique blend of expertise in large-molecule drug development, CMC, and the ability to operate at the intersection of drug and device in a fast-paced environment.
Key Responsibilities
- Translational Research: Design, oversee, and interpret in vivo studies, focusing on safety, efficacy, and translational relevance, ensuring alignment with device development objectives.
- CMC & Formulation Leadership: Lead CMC and formulation optimization for large-molecule drug products designed for our ingestible platform. Oversee phase-appropriate formulation, stability, and forced-degradation studies to ensure product performance and robustness.
- CDMO & Technology Transfer: Support and oversee tech transfer to CDMOs for drug/device combination products, including managing aseptic filling and sterilization activities.
- Regulatory & Quality Partnership: Work closely with Regulatory and Quality teams to support CMC sections of INDs and subsequent regulatory submissions (e.g., Q-subs, IDEs, NDA/BLA).
- Drug-Device Interaction: Provide scientific oversight of the drug-device interaction, ensuring optimal delivery and bioavailability.
- External Partner Management: Manage external partners and research organizations, ensuring timely delivery and high-quality, compliant data (GxP).
- PhD in Pharmaceutical Sciences, Bioengineering, Chemical Engineering, or related discipline with 10+ years of industry experience (startup experience preferred).
- Proven expertise in large-molecule formulation, CMC development, and analytical characterization.
- Experience in drug-device combination products and/or oral delivery technologies is highly desirable.
- Strong experience leading in vivo preclinical studies and working with CROs.
- Proven ability to work in a fast-paced, cross-functional startup environment.
- Excellent communication skills, with the ability to present data to internal and external partners.
- Competitive salary and equity package.
- Comprehensive benefits (medical, dental, vision, PTO).
- Opportunity to lead a breakthrough technology that could impact millions of patients.
Matthew Lowe-Lauri
Senior Division Director
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