Job Description

Job Overview
Manages professional level employees across multiple levels.; Advice on the development of optimum strategies for drug development, product lifecycle management and portfolio management to meet pharmaceutical and biotechnology customer goals (such as strategic leadership of clinical development plans, go/no go decisions, in-licensing, out-licensing, accelerated time to market, etc).; Provide medical, clinical, scientific, regulatory, and product development consultancy expertise to support strategic business activities and investment opportunities.; Participate in the implementation of mission, goals and objectives, development of policies, procedures and standards for the department.; Provide expertise in pharmaceutical product development by preparing publications, white papers, and blogs in areas of expertise and by participating in scientific conferences and webinars, as appropriate. Essential Functions

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  Evaluate and develop product development strategies for pharmaceutical products (drugs, biologics, advanced therapies) focusing on clinical-commercial convergence that encompasses all phases of development from discovery to market, including preclinical strategy, clinical strategy, regulatory strategy, and commercial strategy.
• Complete assessments of risk and probability of regulatory success and develop mitigations for candidate pharmaceutical products, including providing regulatory contributions to indication prioritisation exercises, development strategy evaluations and gap analyses, due diligence, and similar activities.
• Support engagements with regulatory authorities (e.g., FDA, EMA) on behalf of customers, across the lifecycle of drug development from pre-clinical to licensing, including contribution to briefing documents and other meeting materials, and attendance and contribution to meetings and other interactions.
• Develop regulatory submissions, including INDs, marketing/licencing authorisations (NDA/BLA/MAAs), special designations (orphan drugs, pediatics plans, \xe2\x80\x9cfast-track\xe2\x80\x9d, \xe2\x80\x9cbreak-through\xe2\x80\x9d etc\xe2\x80\xa6).
• Ensure high-quality, well-reasoned, objective deliverables (using data-driven design, where available and appropriate) that meet the highest standards of medical, ethical and scientific integrity and conduct.
• Provide drug development expertise to support strategic business activities and investment opportunities.
• Ensure Customer Satisfaction by working closely with Senior Management, CRO Operations, Therapeutic Units, and other Operations Heads to ensure optimum strategic consultancy to customers.
• Serve as a key resource and participate in strategic business development activities including presentations to prospective clients, professional meetings or other business development activities for IQVIA Strategic Drug Development.
• Provide internal and external therapeutic and pharmaceutical development-related educational services in support of all branches of IQVIA business.
• Attend key scientific meetings/conferences and keep abreast of relevant scientific publications to maintain awareness of current scientific developments and progress in drug development methodology
• As appropriate, represent IQVIA or the partner in such meetings.
• Compliance with all business office requirements for tracking of time and effort.

Qualifications

• Typically requires 8 + years of professional experience.
• Possesses deep knowledge of one or more related job areas typically obtained through advanced education combined with experience. Typically viewed as having a specialist within discipline. Utilizes expert knowledge to innovate and ensure best practices are applied in all related project work.
• Expertise in Excel and PowerPoint.
• Strong strategic thinking, analytical and communication skills and ability to thrive in a culture of achievement.
• Client-focused and consultative approach for project management - not just an order taker, but is able to suggest alternate approaches and provide strategic insights that meet client needs.
• Demonstrates a strong command of a variety of analytical and market research techniques.
• Sought out by clients (internal and external) as an analytical expert and, more importantly, as a strategic advisor.
• Grasps key issues quickly, understands the "big picture", and links market research insights to larger business issues relevant to client needs.
• Demonstrates excellent written and verbal communication skills and is effective in a variety of presentation settings.
• Has a strong commitment to quality.
• Has a proven track record of meeting or exceeding goals.
• Has strong people management skills.

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 \xe2\x80\x93 to help our customers create a healthier world. Learn more at https://jobs.iqvia.com