Toxicology Study Manager

Location
New York, NY, United States
Posted
Sep 22, 2021
Ref
2690049805
Discipline
Science/R&D, Toxicology
Hotbed
Pharm Country
Required Education
Bachelors Degree
Position Type
Full time
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 a Nonclinical Study Manager with extensive experience in managing regulated toxicology studies to join our Nonclinical Safety Assessment group. As part of a collaborative team, this individual will be a critical player in the execution of toxicology studies supporting the clinical development of therapeutic candidates. This role will report to the Director, Nonclinical Safety Assessment. The incumbent will play a key role in initiating, managing and tracking all aspects of definitive GLP and non-GLP studies conducted at contract research laboratories (CROs). The ideal candidate has performed this function previously; however, exceptional individuals committed to pursuing a career in nonclinical safety evaluation of therapeutics are encouraged to apply.

RESPONSIBILITIES:
  • Coordinate and monitor GLP and non-GLP toxicology studies at CROs; including CRO selection, qualification, study director interactions, maintaining correspondence and study monitoring.
  • Review study protocols, data, study reports, amendments and regulatory filings for accuracy and completeness.
  • Manage study logistics; schedule, track, and monitor study progress, ensure study protocol and report(s) completed within timelines.
  • Coordinate activities among multiple departments internally and externally (e.g. CMC, QA, etc.); schedule meetings as needed.
  • Manage contracts (CDA, MSA, SOW) with CROs.
  • Assist in preparation and review of Regulatory and QA documents
  • Document and communicate study and program status and issues through monthly reports, timelines, minutes, etc..
  • Ensure regulatory compliance and maintain training/certifications.
  • Work closely with Project Managers and other team members to assure timely deliverables.


REQUIREMENTS:
  • Bachelor's degree in biology, biochemistry, toxicology or other scientific discipline.
  • Minimum 2 years of experience in a pharmaceutical/biotech/CRO setting.
  • Demonstrated understanding of GLP and regulatory requirements for the conduct of toxicology studies.
  • Experience with the design and conduct of regulated nonclinical studies.
  • Strong commitment to quality and accountability.
  • Excellent communication and interpersonal skills.
  • Capacity to complete tasks independently.
  • Strong organizational and project management skills.
  • Ability to work effectively and cooperatively in a team environment within condensed timelines.
  • Able to foster strong working relationships with both internal and external partners.


PREFERRED QUALIFICATION:
  • Masters Degree in biology, biochemistry, toxicology or other scientific discipline
  • Experience in nonclinical safety assessment for all stages of drug development.
  • Experience as a Study Manager or Study Monitor in a nonclinical safety/toxicology group or a Study Director at a CRO.