Associate Director, Bioanalytical Nonclinical Development

Location
New York, NY, United States
Posted
Jun 07, 2021
Ref
2577526091
Hotbed
Pharm Country
Required Education
Bachelors Degree
Position Type
Full time
Direct message the job poster from Ovid Therapeutics

Jennifer Colon
Talent Acquisition Specialist at Ovid Therapeutics

OVID Therapeutics

Ovid Therapeutics Inc. is a New York-based biopharmaceutical company using its BoldMedicine® approach to develop medicines that transform the lives of patients with rare neurological disorders. We believe these disorders represent an attractive area for drug development as the understanding of the underlying biology has grown meaningfully over the last few years and today represents a substantial opportunity medically and commercially. Based on recent scientific advances in genetics and the biological pathways of the brain, we aim to identify, discover and acquire novel compounds for the treatment of rare neurological disorders. We have built a deep knowledge of such disorders, how to treat them and how to develop the clinically meaningful endpoints required for development of a compound in these disorders. We continue to execute on our strategy to build this pipeline by discovering, in-licensing and collaborating with leading biopharmaceutical companies and academic institutions. Ovid's emerging pipeline programs include OV329, a small molecule GABA aminotransferase inhibitor for seizures associated with Tuberous Sclerosis Complex and Infantile Spasms; OV882, a short hairpin RNA therapy approach for Angelman syndrome; OV815, a genetic therapy approach for KIF1A associated neurological disorder; and other non-disclosed research targets.

For more information on Ovid, please visit www.ovidrx.com

POSITION

Ovid Therapeutics is seeking an Associate Director, Bioanalytical Nonclinical Development to join our Research and Early Development (RED) team. The Associate Director will play a key role in developing, implementing and validating bioanalytical methods supporting existing and novel therapeutic programs. This would include small molecule, molecular and/or genetic therapeutics, and would support both internal laboratory activities and development efforts at CROs and with academic collaborators. The position would be based at the company's NYC location and would not be a lab-based position. Within a collaborative team environment, this individual will support all bioanalytical aspects of drug development - from lead identification through drug product validation and will report to the RED director.

RESPONSIBILITIES
  • Lead bioanalytical studies for pre-clinical pipeline within the Research and Early Development (RED) team
  • Plan, organize and monitor activities performed at contracted research organization and within internal labs in support of early pre-clinical programs.
  • Support pharmacology, PK/PD and/or toxicology-related studies
  • Leverage knowledge of design of experiments (DOE) in support of internal bioanalytical development.
  • Familiar with transferring bioanalytical methods between laboratories.
  • Analyze, review, interpret, and report bioanalytical method results from ongoing studies. Lead improvement of test methods through technological innovation in support of product development effort.
  • Able to assess suitability and monitor non-clinical studies at CRO/vendors.
  • Provide technical support to internal and external operations in support of GLP or cGMP activities as needed for translational programs.
  • Implement a testing infrastructure to partner with other technical operations teams in the delivery and interpretation of analytical data.
  • Work with QA to establish SOPs and best practices for all non-clinical bioanalytical activities.
  • Serve as a liaison to regulatory, clinical operations, CMC and other key departments on an as needed basis.
  • Experience in preparing and updating regulatory filings (IND, BLA, MAA).
  • Activities to include, but not limited to, in vitro cell-based assays and immunoassays across multiple platforms to generate data for target engagement, immunogenicity, and quantitation as well as in vivo PK/PD, biomarkers or other potency and efficacy measurements


REQUIREMENTS
  • Bachelors with >15 years' experience in Biology, Biotechnology, Chemistry, or similar.
  • Experience in developing, validating, and performing bioanalytical methods in support of IND and NDA/BLA filings using contract research organizations and/or internal laboratory.
  • Experienced in both in vitro and in vivo bioanalytical analysis planning and execution


PREFERRED QUALIFICATION
  • Master's degree with >10 years' experience in Biology, Biotechnology, Chemistry, or similar.
  • Fundamental understanding of DOE and statistical evaluation of studies.


*Equal Opportunity Employer/Veterans/Individuals w/Disabilities

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