Clinical Pharmacologist – HR050
Location: Bridgewater, NJ
Nevakar is a privately-held, specialty pharmaceutical company committed to developing innovative products in the injectable and ophthalmic space. The company is dedicated to the development of enhanced products that address unmet clinical and/or commercial needs of current FDA approved molecules, through intensive R&D and clinical efforts.
Nevakar’s drug repositioning efforts are focused on the design and development of 1) improved formulation, 2) functional packaging, 3) novel drug delivery approaches, and 4) regulatory and clinical strategies. Resulting new and repositioned products are expected to provide patient-centric benefits while ensuring incremental value proposition for the healthcare system. These new products with proprietary enhancements are filed with the FDA, primarily under the 505(b)(2) regulatory pathway.
- Contribute to the new drug applications and other relevant submissions delivered to the FDA;
- Lend expertise in the design of pre-clinical and clinical phase I-II trials.
- Advise on new innovative/impactful clinical pharmacology approaches to processes and drug development;
- Participate with Regulatory Affairs team in devising and delivering overall development strategy; and
- Educate project team involved in the study on defined areas Qualifications
- PhD, MD, or PharmD degree in Clinical Pharmacology or Pharmacokinetics
- 5+ years of Clinical Pharmacology experience
- Experienced in diverse drug classes, mechanisms of action, toxicology and relevant therapeutic areas
- Good understanding of Clinical Pharmacology testing and pre-clinical/clinical strategies in drug development
- Excellent written, verbal, and interpersonal communication skills
- Equal Opportunity Employer Minorities/Women/Veterans/Disabled