Primary responsibilities include all aspects of Preclinical Development including the design, execution and regulatory submissions of animal pharmacokinetics, pharmacology and toxicology studies, bioanalytical assay development and in vitro pharmacological comparability and similarity studies. The successful candidate will first and foremost be an accomplished preclinical product developmental scientist. Good planning, budgeting and project management and writing skills are a must. In addition you will:
• Design and management of nonclinical studies.
• Initiates and manages contracts, coordinates activities with select Contract Research Organizations (CROs) in the areas of pharmacokinetics, pharmacology, toxicology, PK and immunogenicity assays, and functional bioassays.
• Prepare reports, regulatory documents, INDs and BLAs.
• Works closely with other functional areas and colleagues to insure that all studies are performed in a quality, timely and scientific manner.
• Provides strategic preclinical expertise to cross-functional project teams as the preclinical representative.
• Ensures compliance with GCP, GMP, and regulatory guidelines.
• Demonstrated proficiency in nonclinical study design and management.
• Mastery of preclinical drug development of biologics, strategies, practices and pertinent FDA and EMA regulations absolutely essential.
• Demonstrated results in preclinical development and a track record of successful IND, NDA, BLA and EMA filings.
• Self-organizing, self-directing highly motivated with critical strong thinking and analysis skills.
• Excellent writing and language skills along with strong communication and team management skills. Excellent presentation skills.
• Exceptional computer and software literacy in relevant areas.
• Previous experience and success with choosing, negotiating, and managing relations with contractors, including CROs.
Education and Experience:
• Ph.D. in pharmacology, physiology, immunology, cell biology, or related discipline. DABT preferred but not required.
• Direct experience designing and executing rodent and primate PK and safety studies for biologics.
• Experience in bioanalytical PK and immunogenicity assays to support preclinical and clinical development and in functional bioassays.
• Minimum of 10 years of pharmaceutical/biotechnology industry experience.
• Minimum of 5 years hands-on expertise developing and executing preclinical studies
• Experience in working with U.S. and European regulatory authorities required.
• Experience with all phases of pre-IND through Phase I/II/III programs and associated regulatory filings.