SENIOR DIRECTOR, REGULATORY STRATEGY LEAD (HOME-BASED)

Job Overview Provide leadership and advice on the development of optimum regulatory strategies for drug development, product lifecycle management and portfolio management, particularly focused on emerging biopharmaceutical company customer goals in oncology.
Provides strategic regulatory advice towards efficient clinical development and navigation of US & European regulatory frameworks.
Responsible for the development of regulatory business, in accordance with RADDS and Corporate business plans.
Participates in project-related work, as necessary.
Provide scientific, regulatory, and product development leadership and consultancy expertise to support strategic business activities and investment opportunities.; Provide thought leadership in regulation of bio-pharmaceutical products by preparing publications, white papers, and blogs in areas of expertise and by participating in scientific conferences and webinars, as appropriate.
Essential Functions Integrate strategic regulatory & drug development support services into emerging biopharmaceutical company clinical trial offerings.
Interface with clients in collaboration with existing Therapeutic Science & Strategy Unit Centres of Excellence to provide strategic advice and incorporate regulatory guidance.
Support engagements with regulatory authorities (e.
., 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.
Lead assessments of risk and probability of regulatory success and development of mitigations for candidate pharmaceutical products, including providing regulatory contributions to indication prioritization exercises, development strategy evaluations and gap analyses, due diligence, and similar activities.
Support the innovative development of compounds to maximize technical, regulatory, and commercial success, including contribution to the development of Target Product Profiles (TPPs), Clinical Development Plans (CDPs), clinical study designs, synopses, and protocols, as appropriate.
Strategic leadership of the development of regulatory submissions, including INDs, marketing/licensing authorizations (NDA/BLA/MAAs), special designations (orphan drugs, pediatrics plans, “fast-track”, “break-through” etc…).
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.
Assume the role of customer senior management as requested, including membership of virtual cross functional drug development teams.
Provide regulatory strategy expertise to support strategic business activities and investment opportunities.
Assist in the development of programs to maximize the organization’s growth and profitability.
Ensure Customer Satisfaction by working closely with Senior Management, CRO Operations, Therapeutic Units, and other Operations Heads to ensure optimum strategic consultancy to customers.
Provide internal and external strategic regulatory 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 regulatory strategy As appropriate, represent IQVIA or the partner in such meetings.
Develop and maintain ongoing relationships with pharmaceutical and biotechnology companies, key opinion leaders Identify new business opportunities.
Compliance with all business office requirements for tracking of time and effort.
Required Knowledge, Skills, and Abilities Relevant science degree & post graduate specialization or equivalent experience in medicinal product development and regulatory strategy.
Strategic regulatory experience in novel oncology investigational product development to registration including interactions with US and European regulatory authorities.
Prior regulatory authority experience desirable.
Typically requires + years relevant clinical research and/or regulatory experience with multi-regional and global focus including significant experience in senior strategic role, including specific oncology investigational product experience Requires broad management and leadership knowledge to lead multiple job areas, the ability to influence others to accept practices and approaches.
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\