Position: Pharmacologist/Toxicologist
Applicants are invited to apply for a Pharmacologist/Toxicologist position at Biothera. Individual is expected to have broad knowledge in the areas of safety pharmacology, pharmacokinetics and toxicology, with experience applying such knowledge to successful drug development.
Primary responsibilities include:
- Oversight of safety pharmacology, pharmacokinetic, and toxicology (all phases) study performance to support drug development; includes CRO selection, site audits, protocol design, study management, budget oversight, and report writing.
- Coordinated interpretation of safety pharmacology, pharmacokinetic, and toxicology study results from legacy and new studies and preparation of summary documents describing results.
- Writing/reviewing/managing safety pharmacology, pharmacokinetic, and toxicology sections for IND/ Annual Report/ BLA regulatory submissions and associated documents such and Investigator Brochures, etc.
- Representing the Company with Regulatory Authorities (e.g., FDA) on issues related to safety pharmacology, pharmacokinetics, and toxicology.
- Providing support to Clinical, Regulatory Affairs, Legal, and Marketing to coordinate pharmacology and toxicology activities related to company goals and objectives.
- Providing support to Clinical related to literature searches and exploration of potential new indications, etc.
Educational Requirements and Experience include:
- PhD (with DABT qualification an advantage)
- Proven working knowledge of safety pharmacology, pharmacokinetic, and toxicology regulatory guidelines (FDA and ICH), as well as GLP guidelines
- Experience in Study Management/Project Management
- Excellent oral and written communication skills, as well as
organizational and interpersonal skills
- Previous biotechnology or pharmaceutical experience
Email resume to jobs@biothera.com. No calls please.