• Responsible for leading the Company’s non-clinical strategy and providing scientific input into research and development programs in support of the overall corporate strategy.
• Accountable for the design, execution, analysis and interpretation of non-clinical development studies, to enable timely and successful regulatory submissions.
• Ensure the integration of non-clinical programs with planned clinical programs; secure cross functional alignment and transparent discussion of opportunities and risks; and create clear plans to further investigate, optimize, and track throughout development.
• Serve as the responsible non-clinical lead for preparation of internal documents and of documents for Regulatory submission.
• Provide guidance on potential Business Development opportunities; participate in ad hoc Due Diligence activities; and provide expertise from a non-clinical development perspective to Corporate Development.
• Manage multiple, at times conflicting priorities, and proactively seek viable solutions to resolve such conflicts.
• Appropriately balance internal infrastructure and capabilities versus outsourcing options, while ensuring systems are in place to safeguard a GxP-compliant environment.
• Maintain an up-to-date knowledge of Regulatory agency pharmacology and toxicology regulations and guidelines.
• Maintain a command of external scientific literature and apply this to internal projects.
• Represent non-clinical development as a Subject Matter Expert and thought leader; develop and maintain relationships with relevant Key Opinion Leaders and academic researchers.
• Develop and administer budgets, resource plans and performance objectives for functional area staff.
• Identify and evaluate novel drug development opportunities and candidates, and plan the progression of these into IND-enabling studies and into human PoC clinical trials.
• Oversee the design and execution of in vivo studies, with new in vivo models as necessary.
• Generate key translational data using to guide indication selection, develop biomarker assays for use in clinical studies, and identify target patient populations for programs.
• PhD and/or MD in a drug development-related discipline; with minimum of 10+ years of experience in the pharmaceutical or biotechnology industry, and 8+ years of direct experience in non-clinical development. An equivalent combination of education and applicable job experience can be considered.
• A broad understanding of drug development as evidenced by a track record of contributions to successful patents, Regulatory Agency briefing packages and interactions, INDs, NDAs, drug approvals, partnership or in-licensing deals, and/or peer reviewed publications.
• An understanding of business aspects of the pharmaceutical / biotech industry, including experience in business development, due diligence, and licensing contracts.
• Experience with the design of GLP studies and with the preparation of Study Reports suitable for Regulatory submission is desired.
• Toxicology expertise is a plus.
• Global experience (with ex-US regulatory agencies and/or with ex-US companies) is a plus.
• Experience of study outsourcing including CRO selection and monitoring.
• Experience building and managing collaborations with scientists, consultants, pharmaceutical partners and other outside organizations.
• Familiarity with validation of drug targets and the exploratory drug development process.
• Ability to multi-task and to handle multiple programs.
• Strong interpersonal and organizational skills and excellent verbal and written communication.
• Ability to travel approximately 10% domestic and internationally.
Requisition ID : 1252