Job Description

Job Level: Senior Director, Regulatory Strategy and Drug Development

Location: Home-based in USA/Europe

Job Overview:

Manages a department or small unit.; Provide leadership and advice on the development of optimum regulatory strategies for drug development, IND and marketing approval, 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 DDRS 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:

• 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…)
• 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.
• Lead and develop a global regulatory team, including line management activities.
• Support 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.
• 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.
• 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.
• 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.
• 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 DDRS
• 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

Qualifications:

• Masters degree or higher or the equivalent combination of education, training and experience.
• Typically requires 15-20+ years relevant clinical research experience with multi-regional and global focus including significant experience in senior strategic role.
• 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", 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 broad management knowledge to lead teams and leadership knowledge to lead multiple job areas.
• Has ability to influence others to accept practices and approaches.

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IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

The potential base pay range for this role, when annualized, is $186,300.00 - $519,000.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.