Cello Therapeutics, Inc. is a rapidly growing biotech company located in the Sorrento Valley—one of the major biotech hubs in the nation. Cello focuses on the development of novel nanotherapeutics based on biomimetic cell membrane-coated nanoparticles for cancer treatment. Cello offers a highly motivational and rewarding working environment with attractive salary and benefits.
The Pharm-Tox Consultant will be a key leader of our teams and will be responsible for providing valuable input on the design, analysis, interpretation, and reporting of Safety Pharmacology and Toxicology data for Cello’s programs. The candidate will communicate directly with all departments (i.e. R&D, Product Development, CMC, Quality, etc.) at Cello Therapeutics and will liaise with Research and Development colleagues to develop overall Safety Pharmacology and Toxicology development strategies. S/he will help to guide preclinical development of Cello’s programs and regularly interface with internal and external colleagues to ensure timely and accurate conduct and dissemination of Safety Pharmacology and Toxicology studies. Primary duties include:
- Drive the strategic scientific direction for Cello’s product development
- Provide guidance on the conduct, interpretation, and reporting of Safety Pharmacology and Toxicology studies/data
- Set priorities within the Pharm/Tox function and manage assignments to meet them
- Provide strategic advice on the impact of toxicology results on Cello’s clinical/regulatory strategies
- Provide insight into specific pharm/tox issues within the context of ongoing and future company programs.
- Oversee the preparation of Safety Pharmacology and Toxicology sections of regulatory documents (briefing books, IND, CTA, NDA, investigator brochures, etc.)
- Facilitate timely preparation of pharm/tox sections for high quality regulatory submissions
- Oversee the preparation of data summaries and presentations of pharm/tox results
- Oversee the preparation of SOPs as needed to guide functional activities
- Develop and maintain working relationships internally and with partner organizations
- Proactively conduct background research needed and to propose effective and creative solutions
- Be knowledgeable of currently regulatory guidances
- Maintain relationships with investigators and identify/interact with key opinion leaders
Desired Education, Skills, and Experience:
- 10+ years of pharmaceutical/biotech experience, with particular emphasis on safety pharmacology and toxicology
- M.S./Ph.D in Toxicology, Pathology, or closely related discipline; or D.V.M. with 7+ years of experience as noted above
- Knowledge of toxicologic pathology
- Extensive experience in the preparation of regulatory documents such as briefing books, IND, CTA, NDA, investigator brochures, etc.
- Prior experience in drug development across mixed modalities and an extensive scientific knowledge of pharmacology, toxicology, immunology, cell/molecular biology, physiology, and biochemistry
- Prior experience in designing pharm/tox studies for nanoformulations is a plus
- Demonstration of leadership in pharm/tox strategy and experience with regulatory interactions
- Applies in-depth knowledge of pharm/tox and business/commercial/scientific expertise to solve critical issues successfully and innovatively
- Possesses broad knowledge of scientific principles and theories and possess intellectual mastery of multiple scientific areas
- Excellent conceptual, strategic, analytical, problem solving, and organizational skills
- Excellent verbal and written communication skills
- Ability to operate proactively and independently
- Self-motivated, detail-oriented, and decisive
Successful candidate must be authorized to work in the United States.
Cello Therapeutics, Inc. is an equal opportunity employer.