Tavanta Therapeutics is a clinical stage specialty pharmaceutical company developing a diverse pipeline of drugs that bring clinically meaningful benefits to patients with serious or debilitating diseases. As we continue to grow and expand, there exists an immediate opportunity for a Director / Principal Scientist of Pharmacology and Toxicology professional to join our Team. The incumbent will be responsible for pharmacology, pharmacokinetic and toxicology studies at Tavanta.
Essential Duties and Responsibilities
- Lead preclinical pharmacology and toxicology strategy and activities, present timelines, budget and scientific data at team meetings. Contribute to Project Teams as determined within the internal matrix structure
- Evaluate and select animal disease models for preclinical programs and design pharmacokinetic and toxicology studies to address key scientific questions and ensure preclinical pharmacology/ toxicology data will address FDA requirements for IND approval.
- Ensure preclinical pharmacology and toxicology studies are run in accordance with the appropriate SOPs, relevant regulatory guidelines, legislation and departmental processes as required per study.
- Provide Preclinical Pharmacology and Toxicology contributions to regulatory documents
- Support a diverse set of preclinical programs to identify critical pathways in disease pathophysiology and possible targets for drug molecules
- Identify, select and manage CROs for outsourced preclinical experiments. Provide technical input into protocol design and reports from pre-clinical CROs
- Maintain good working relationships with contracted parties (CROs) on planned and ongoing pharmacology studies, as well as with relevant key opinion leaders and researchers
- Knowledge, Skills and BehaviorsThe candidate will have strong, proven background in Pharmacology and Toxicology. In addition, the candidate should have significant experience within the pharmaceutical industry, preferably in a small biotechnology and/or specialty pharmaceutical company. The Director / Principal Scientist, Pharmacology and Toxicology must be an enabler and educator to internal and external teams.
- Experience in the pharmaceutical industry delivering the pharmacokinetic and toxicology aspects of drug development programs from early concept through to late stage clinical evaluation.
- The candidate should have a strong working knowledge of regulatory requirements
- Minimum of Pharmacology degree with significant experience in the pharmaceutical industry. Thorough understanding of pharmacokinetics and physiology
- Excellent oral and written English is essential
- Team oriented and goal-driven while being self-aware of strengths and weaknesses
- Highly organized and able to work on his/her own with limited oversight
- Collaborative, creative, and open-minded, and eager to help others
- Persistent and optimistic about overcoming obstacles and uncertainty
- Flexible and willing to try/learn new things and approaches