Senior Director, Drug Development

🕒 July 20

🇬🇧 United Kingdom – Remote

⏰ Full Time

🟠 Senior

👔 Director

🇬🇧 UK Skilled Worker Visa Sponsor

This company has sponsored UK Skilled Worker visas in the past.

👻 Ghost score 50%

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IQVIA

WebsiteLinkedInAll Job Openings

10,000+ employees

💼 Consulting

🏭 Manufacturing

📣 Marketing

💰 $1G Post-IPO Debt on 2023-05

Consulting • Manufacturing • Marketing

IQVIA is a global leader in data analytics and technology solutions, dedicated to improving health outcomes. The company utilizes its Connected Intelligence platform to harness the power of advanced data analytics and artificial intelligence, facilitating innovation in healthcare. IQVIA focuses on various areas, including clinical research, technology, and consulting services to solve complex healthcare challenges and accelerate the delivery of new therapies to patients.

📋 Description

• Manage a department or small unit • Provide leadership and advice on regulatory strategies for drug development, INDs, marketing approval, product lifecycle management, and portfolio management, particularly for oncology-focused biopharmaceutical customers • Advise on US and European regulatory frameworks • Develop regulatory business in accordance with DDRS and Corporate business plans • Participate in project-related work • Provide scientific, regulatory, and product development leadership and consultancy • Prepare publications, white papers, and blogs and participate in scientific conferences and webinars • Lead strategic development of regulatory submissions, including INDs, NDA/BLA/MAAs, and special designations • Support regulatory-authority engagements with FDA and EMA throughout drug development • Lead and develop a global regulatory team, including line management • Assess regulatory risk and probability of success and develop mitigations • Evaluate product development strategies across discovery, preclinical, clinical, regulatory, and commercial phases • Contribute to Target Product Profiles, Clinical Development Plans, clinical study designs, synopses, and protocols • Ensure high-quality, objective, scientifically and ethically sound deliverables • Represent customer senior management and participate in virtual cross-functional drug development teams • Ensure customer satisfaction through collaboration with senior management, CRO Operations, Therapeutic Units, and Operations Heads • Participate in strategic business development activities and presentations to prospective clients • Attend scientific meetings and monitor relevant scientific publications

🎯 Requirements

• Master's degree or higher or the equivalent combination of education, training and experience • Typically requires 15–20+ years of relevant clinical research experience with multi-regional and global focus, including significant experience in a senior strategic role • Broad management and leadership knowledge to lead multiple job areas • Ability to influence others to accept practices and approaches • Expertise in Excel and PowerPoint • Strong strategic thinking, analytical, and communication skills • Client-focused and consultative approach to project management • Strong command of analytical and market research techniques • Excellent written and verbal communication skills • Strong commitment to quality • Proven track record of meeting or exceeding goals

🏖️ Benefits

• Not specified