Director of Non Clinical R&D

Director of Non-Clinical

San Francisco, CA

Company Overview:

Our client is a cutting-edge biotech startup revolutionizing the field of genetic medicine with our proprietary Lipid Nanoparticle (LNP) technology. Our patented delivery mechanism offers superior efficacy and safety compared to traditional RNA or DNA delivery methods. Founded by a visionary PhD graduate from Stanford University, we are driven by a passion for innovation and a commitment to transforming healthcare through advanced biotechnology.

Position Overview:

We’re seeking a highly skilled and motivated Director of Non-Clinical to lead our preclinical research efforts.

The successful candidate will be pivotal in advancing our LNP platform through rigorous experimentation and data-driven decision-making. This individual will build a talented team of scientists and researchers, design the strategy, research plan, and operation plan, set up the lab, and design the experiments, in close collaboration with other functional areas to drive the development of novel therapeutics.

Key Responsibilities:

1. Lead and manage the Non-Clinical team to design, plan, and execute preclinical studies evaluating the efficacy, safety, and pharmacokinetics of LNP-based therapeutics.

2. Develop and implement comprehensive research strategies to optimize LNP formulations and delivery systems, leveraging a deep understanding of lipid nanoparticle technology and its applications.

3. Establish and maintain strong relationships with external partners, including contract research organizations (CROs) and academic collaborators, to support preclinical studies and ensure timely project execution, including technology transfer and QC.

4. Drive the generation of high-quality scientific data to support regulatory submissions, including IND filing, and advance product development milestones.

5. Collaborate cross-functionally with colleagues in research, clinical development, regulatory affairs, and manufacturing to integrate non-clinical findings into overall product development strategies.

6. Stay abreast of the latest advancements in lipid nanoparticle technology, RNA/DNA therapeutics, and relevant scientific literature to inform decision-making and maintain a competitive edge.

7. Contribute to scientific publications, presentations, and patent applications to communicate research findings and protect intellectual property.

8. Foster a culture of scientific excellence, innovation, and collaboration within the Non-Clinical team and across the organization.

Additional Information:

• Experience with filing Investigational New Drug (IND) applications and navigating regulatory processes for drug development, including interactions with regulatory agencies such as the FDA.

• Familiarity with protein engineering techniques and their applications in therapeutic development, particularly in the context of lipid nanoparticle-based delivery systems.

• Leadership role in overseeing non-clinical activities post-IND, including toxicology studies, pharmacology assessments, and IND-enabling studies.

• Onsite presence required in San Francisco, facilitating collaboration and communication with cross-functional teams.

• Lead researcher responsible for coordinating activities with contract research organizations (CROs), including technology transfer, quality control (QC), and oversight of studies conducted externally.

• Direct involvement in the design and development of experiments and protocols sent to CROs, ensuring alignment with project goals and objectives.

• Experience working with laboratory facilities such as Bakar and NBC, leveraging their expertise and resources for research and development activities.

We Offer

• Competitive salary in the range of $200,000 to $250,000, commensurate with experience and qualifications.

• Opportunity for a 20% performance-based bonus, reflecting the company's commitment to rewarding exceptional contributions.

• Equity participation in the range of 3-5%, providing a stake in the company's success and alignment with long-term growth objectives.

Join us and be part of a dynamic team driving innovation at the intersection of biotechnology and medicine. Together, we are pioneering new treatments and improving the lives of patients worldwide. Apply now to make a difference!