Who we are:

Osanni is Designed for Sight. We are creative & agile innovators, passionate about developing breakthroughs to save eyesight.

At Osanni we are creating a uniquely different biotech company with the talent and unconventional thinking to deliver therapies to prevent and reverse blindness caused by retinal diseases. 

We focus where others aren’t. Retinal diseases are multi-factorial, so we are using our energy and ingenuity to navigate our own original path to address these sight-threatening conditions.  Our approach to drug development brings creativity to science through design thinking.  We are committed to tackling the toughest challenges and creating fundamentally different approaches to save vision.  Our belief is that if we hold patients’ eyesight and physician practices as our North Star, it will enhance our purpose, decision making, and our impact.

We are building a highly skilled and passionate team that truly enjoys the challenge of conquering the agility course of drug development and entrepreneurship. People are our greatest asset in achieving our ambitious mission at Osanni. 

We are based in the vibrant incubator located in San Carlos, CA. 

Introduction to the Role:

Osanni is looking for a highly skilled, motivated, and creative Nonclinical Development Scientist to join Osanni’s Development Organization. The primary function of this senior position is to is to lead, develop and implement nonclinical strategy to enable development of new intraocular products intended for clinical trials and commercialization. The candidate will be part of cross-functional teams providing nonclinical leadership on projects, working closely on a shared mission to bring new ocular therapeutics to patients.

The essential components of this position are in-depth understanding of Nonclinical development principles especially PK/PD, regulatory & GLP requirements as well as strong organizational skills to enable development of products intended for clinical trials and commercialization.

Key Responsibilities:

• Contribute effectively towards strategic and tactical development of project plans with key emphasis on nonclinical aspects and phase appropriate development.
• Responsible for design, execution, analysis, interpretation, and communication of non-clinical studies conducted at contract laboratories and in-house in support of Osanni's research and development programs. These studies may include non-clinical toxicology, pharmacokinetics/toxicokinetics (PK/TK), and biological research.
• Perform human PK projection, and contribute to the analysis of preclinical PK/PD data for selection of FIH dose levels.
• Manage contract laboratories and ensure delivery of high-quality nonclinical reports that meet regulatory requirements.
• Author and review technical reports, technical data packages, and applicable nonclinical sections in health authority filings (including INDs, IBs, NDAs, annual reports, and other regulatory interactions)
• Collaborate effectively within Osanni teams and outside contract laboratories with excellent communication to maintain strong relationships.
• Have excellent communication (oral and written) and interpersonal skills to be able to effectively communicate scientific conclusions and project topics with key stake holders and company leadership.

 

Required Skills and Background:

• Ph.D. in Pharmacokinetics, Toxicology, Pharmacology, or related scientific discipline with at least 8 years of experience in the biopharmaceutical industry
• Have comprehensive knowledge of relevant pharmacokinetics (PK) principles, and experience integrating PK/ADME data with pharmacology and toxicology profiles
• Strong knowledge of ADME concepts, pharmacokinetic modeling, pharmacodynamic and bioanalytical principles
• Working knowledge of pharmacokinetic and other analysis software (e.g. WinNonlin, NONMEM, etc.) and demonstrated ability to plan, organize, and critically assess and/or perform PK/PD data analyses
• A good knowledge of current regulatory guidelines
• Excellent technical writing skills and experience authoring development reports, SOPs, regulatory filings, or other documents.
• Strong written and verbal communication skills, and efficient in communicating in inter-disciplinary and cross-functional teams including contract laboratories.

 

 The expected base pay range for this position is $150,000 - $200,000 plus bonus and comprehensive benefits.  The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training.

We are committed to creating a diverse environment and are proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.

We will provide an intellectually stimulating, collegial and fast-paced environment. If you are ready to be a part of designing the future of sight-saving therapeutics, then we are excited to hear from you! Please contact us and include your CV or résumé.