Roivants mission is to systematically reduce the time, cost, & risk of delivering new medicines to market by accelerating the development of promising drug candidates to improve the lives of patients & their families. The company is privately held, has in-licensed 25+ assets, & is very well-capitalized. The Roivant R&D team works hand in hand with Business Development & the Chief Medical Offer to establish the scientific rationale & initial development strategy for novel drug in-licensing opportunities

Position Title: VP, Head of Non-Clinical Development 

Position Location: New York, NY (Location arrangements flexible) 

Manager Title: Chief Medical Officer, Roivant Sciences 

Position Summary: The VP, Head of Non-Clinical Development will be responsible for evaluating the nonclinical safety, efficacy, & ADME/PK of potential in-licensing opportunities & crafting the initial nonclinical development strategy for new assets across a variety of therapeutic areas. They will play a critical role on the Roivant R&D team, aggregating nonclinical experience & knowledge & soliciting input from functional leadership to formulate strategy that will support the development of investigational drugs through registration. They will provide guidance & support for newly created subsidiary companies (Vants) that are formed to develop in-licensed assets.

Responsibilities: 

• Play a key role in due diligence efforts for potential drug acquisitions, including review of existing data & development of nonclinical strategy to support the clinical hypotheses
• Lead nonclinical diligence efforts, summarizing key gaps/risks across all functional lines.
• Develop staffing plan to enable nonclinical program for new Vants.
• Continually review & monitor guidance, regulations & publications relevant to nonclinical development across multiple therapeutic areas & modalities
• Assess nonclinical safety findings for potential expedited safety reporting
• Provide input on clinical safety programs (informed consent, exclusion criteria, pregnancy, etc.)
• Identify & work with expert consultants depending on project-specific needs
• Interact with regulatory agencies (responses to queries, preparation of pre-meeting documents, attend teleconferences & meetings with Health Authorities, as needed)
• Participate in the selection of nonclinical leadership within newly created subsidiary companies & partner with them to transition clinical strategy to subsidiaries responsible for execution
• Where needed, provide guidance, support, & execution oversight for new subsidiaries

Skills, Qualifications, & Requirements: 

• PhD or DVM
• Board certification in toxicology (DABT) preferred
• 10 years + pharmaceutical industry experience
• Knowledge of drug development & understanding of life cycle management concepts & interdependencies with the overall development process
• Previous experience working in a project team & interacting with other disciplines in the development team (e.g. Project Management, CMC, Clinical/Medical Affairs, Regulatory, etc.)
• Extensive experience in pharmaceutical toxicology
• Prior experience as a nonclinical safety assessment project team member
• Experience writing the nonclinical safety assessment portions of regulatory documents
• Excellent written & oral communication skills
• Proven ability to manage multiple projects/tasks at one time