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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
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