Spirovant is looking for an Associate Director, Non-Clinical Development. The successful candidate will be responsible for the design, initiation, execution, and reporting of externally placed in vitro and in vivo studies.  The candidate will be responsible for identifying laboratories (academic or CRO) to conduct needed studies and for establishing study budget and timelines.  The candidate will qualify necessary sites and serve as Study Monitor.  In collaboration with the VP, Nonclinical Development, will conduct due diligence and/or provide oversight to the nonclinical toxicology studies; as well ADME/PK and pharmacology studies.  The incumbent will also be expected to draft nonclinical regulatory documents for INTERACT, preIND, IND, EoPII, NDA/BLA filings etc, and represent the nonclinical function on internal project team meetings.

Responsibilities:

·        Design, execute, monitor, and interpret findings from nonclinical studies for advancing candidates to global registration

·        Interface with contract research organizations (CROs) to request quotes for selection of testing labs and serve as Study Monitor

·        Conduct detailed technical evaluation of non-GLP and GLP toxicology, DMPK, and pharmacology studies in support of Spirovant pipeline assets, as well as assist in due diligence efforts.  Identify gaps in development plan(s) and establish timelines and budget for a comprehensive development plan

·        In collaboration with the VP, Nonclinical Development, develop nonclinical strategies for global registration

·        Provide SME support to other individuals / groups within Spirovant as needed

·        Participate in the scope-creation, execution, and oversight of Strategic Research Agreements with external collaborators

·        Provide oversight to external consultants in the nonclinical area, as needed

 

Requirements:

·        MSc or PhD in relevant biological sciences (Toxicology, Pharmacology, Drug metabolism, etc.) or DVM

·        Board certification in toxicology (DABT) preferred

·        5+ years pharmaceutical or CRO industry experience (8+ for Director)

·        On-the-job experience in conducting and monitoring studies under GLP regulations

·        Knowledge of drug development and understanding of life cycle management concepts and interdependencies with the overall development process

·        Experience in nonclinical aspects of gene therapy (strongly preferred), monoclonal, protein/peptide or vaccine development

·        Excellent written and oral communication skills

·        Proven ability to independently manage multiple projects/tasks at one time

·        Ability to travel to CRO partners, and Philadelphia main office, on an as-needs basis (up to 30% of time). 

Spirovant is committed to fostering a diverse, inclusive environment and is proud to be an equal opportunity employer.