Senior Director, Head Of Nonclinical Center Of Excellence

Oversee the newly formed Nonclinical Center of Excellence (CoE) within the Regulatory Affairs and Drug Delivery Solutions (RADDS) department. Using broad management discretion, you will have direct responsibility for the design and elucidation of complex product development strategies for drugs, biologics, and biotechnology products focusing on nonclinical product development ensuring quality deliverables are on time, within budget and that all work is completed in accordance with SOPs, policies and practices. In addition, you will contribute to development of gap analyses, indication prioritizations, target product profiles, nonclinical and clinical development plans, clinical study designs, author and review documents for regulatory meetings and submissions, and other work products in your area of expertise.

RESPONSIBILITIES
• Line Management/functional responsibilities for multiple junior/mid-level nonclinical subject matter experts (SMEs). Serve as the most senior nonclinical SME within including regularly being responsible for the development of regulatory business and supporting broader business development.
• Hands-on review and/or creation of Nonclinical product development strategies to meet regulatory requirements for first-in-human and/or registrational clinical studies
• Strategic regulatory guidance, including integrating nonclinical information to appropriately time and design clinical studies to address safety related issues, in particular safety & efficacy interactions.
• Provide interpretive guidance for strategic decision making critical for safety, marketability and regulatory requirements
• Utilize extensive expertise in toxicology & DMPK to evaluate toxicokinetic responses identified in nonclinical product development and guide subsequent evaluation in clinical studies for safety related issues (e.g. liver enzyme elevations, transport interactions, etc).
• Review product development strategies (both nonclinical and clinical) to assess compliance with EPA, FDA/EMA guidance, regulation, and applicable drug law, GLP, E, ICH
• May act as a global contact and/or lead for a specific customer
• May take a proactive role in developing long standing relationships with preferred IQVIA customers, and may take a leadership role in bid defense strategy and planning, as appropriate
• Continually looks for process improvements
• Competently manages meetings/expectations with Regulatory Agencies and/or groups within IQVIA
• May lead major, global cross-functional initiatives, accountable for success
• May represent IQVIA by leading a cross-industry workgroup in an area of expertise

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
• Held positions of increasing responsibility in the pharmaceutical, biotechnology and/or CRO sectors
• Extensive experience in development of Nonclinical regulatory strategy and development plans
• Strong experience in regulatory agency interaction
• Small molecule, Peptide, Biological and CAGT experience preferred
• Extensive expertise in toxicology & DMPK
• Expertise in Good Laboratory practices, worldwide regulations, safety assessment SOP’s, protocols, policies and procedures
• Extensive experience in regulatory and/or technical writing and/or process management
• Ability to make difficult judgment calls within sphere of responsibility. Demonstrates advanced negotiating, influencing and motivating skills, with the ability to identify and resolve issues at a senior level within IQVIA and customer organizations
• Strong software and computer skills, including MS Office applications
• Acts as a role model for professionalism and a respected ambassador for the Strategic Drug Development and IQVIA, remaining effective in difficult, stressful and/or highly sensitive situations
• Ability to accept senior management decisions and deliver positive messages to peers
• Ability to communicate effectively at all levels in the organization, consistently demonstrating confidence and authority within remit
• Ability to monitor the market and demonstrate knowledge of competitors and clients

MINIMUM REQUIRED EDUCATION
Advanced degree in life science-related discipline or professional equivalent* plus extensive strategic nonclinical regulatory experience (*or combination of education, training and experience). Board certified toxicologist is a plus.

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com