Director of In Vivo Pharmacology
2 days ago
SonoThera is a pioneering biopharmaceutical company that has developed a groundbreaking ultrasound-guided non-viral gene therapy platform. Our innovative platform enables the precise and non-invasive delivery of large payloads of diverse formats (DNA, RNA, and combinations thereof) to various organs in the body, providing durable expression and re-dosing capabilities without off-target delivery.
Our company culture is built on a collaborative, interdisciplinary, and forward-thinking approach to addressing the challenges facing genetic medicine discovery and drug development. Headquartered in South San Francisco, CA, we are committed to advancing the field of gene therapy.
Job SummaryThe successful candidate will be a key member of our Research team, responsible for designing, implementing, and overseeing in vivo pharmacology studies to support the development of ultrasound-mediated gene therapy programs. This role will lead the research staff within the in vivo team and collaborate with cross-functional partners to manage resource allocations and enable portfolio progression.
Projects requiring pharmacology support may span from platform development, target validation, preclinical development, to translational biology. The ideal candidate will have a strong background in in vivo pharmacology and experience in managing teams and cross-functional projects in the gene therapy field.
Key Responsibilities- Provide leadership in platform innovation and preclinical program development to support successful FDA IND application(s) for gene therapy drug candidates.
- Manage in-vivo pharmacology studies, including design, implementation, conduct, and reporting structure.
- Facilitate the conceptualization and development of innovative research strategies and plans for preclinical studies aligned with the company's therapeutic portfolio and goals.
- Identify, assess, and oversee contract research organizations (CROs) to complement internal capabilities and generate critical pharmacokinetic, pharmacodynamic, and efficacy data.
- Investigate and initiate innovative approaches to identify appropriate pre-clinical and clinical biomarkers.
- Foster effective collaboration and communication with internal teams, external partners, and key stakeholders to ensure alignment of research objectives and facilitate knowledge sharing.
- Perform independent investigational research within the field of study to provide leadership and advance optimization of in vivo research methodologies, technologies, and industry trends.
- Develop and present Pharmacology strategy, plans, and data at project team meetings and to management to support project objectives.
- Support the filing of regulatory documents, including preparation of final study reports and IND (or related) documents.
- Contribute to a team culture that promotes collaboration, open communication, career development, excellence, ownership, curiosity, and inclusion.
MD/PhD in Molecular & Cell Biology, Genetics, Biochemistry, Immunology, Physiology, or related areas.
Minimum 15 years of experience designing, executing, and overseeing in vivo pharmacology studies to support projects in the pharmaceutical or biotech industry.
Previous experience managing in vivo pharmacology studies in an industry setting, with experience in overseeing non-GLP and GLP studies is required.
Minimum 10 years of experience managing teams and cross-functional projects, preferably in the gene therapy field.
Experience in generating and managing pre-IND reports is strongly preferred.
Prior experience with gene therapy platforms is strongly preferred.
Previous experience working in fast-paced start-up environments preferred.
Technical Requirements and SkillsStrong technical expertise in study design methodologies, a wide range of in vivo disease models, and in vivo techniques including imaging.
Strategic thinker with the ability to analyze possibilities, evaluate benefits/risks, and mitigation strategies and solutions.
Strong leadership, program management skills, including experience in building, leading, and developing strong and collaborative scientific teams.
Strong communication skills, with the ability to effectively collaborate with cross-functional teams and external partners.
Demonstrated ability to stay updated with the latest advancements and trends in in vivo research.
Must be proactive and able to work effectively on multiple projects in a fast-paced, dynamic environment.
Strong written and verbal communication skills.
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