Senior Director, Regulatory Strategy Leader-Oncology

IQVIA • Durham, NC

1d • $186,300 - $519,000

About The Position

Provide leadership and advice on regulatory and biostatistical strategies for drug development, product lifecycle management, and portfolio management, with a particular focus on the goals of emerging biopharmaceutical companies. Advise on efficient clinical development and navigation of U.S. and European regulatory frameworks, with limited project-related participation as a subject matter expert. Provide scientific, regulatory, and product-development leadership and consultancy to support strategic business activities and investment opportunities. Support organizational policy initiatives and provide thought leadership through publications, white papers, blogs, scientific conferences, and webinars. Lead work involving emerging novel trial designs and tools, including digital twins.

The role integrates strategic regulatory, statistical, and drug-development services into clinical-trial offerings; advises clients through the Therapeutic Science & Strategy Unit Centres of Excellence; supports regulatory-authority engagements and submissions throughout drug development; and contributes to strategic consulting, business development, education, and organizational growth. The position also involves maintaining relationships with pharmaceutical and biotechnology companies and key opinion leaders, representing IQVIA or partners at meetings as appropriate, and meeting business-office time and effort tracking requirements.

Requirements

• Bachelor’s degree or equivalent experience.
• 15 or more years of relevant clinical research and/or regulatory experience, with a multi-regional and global focus, including significant experience in a strategic role.
• Broad management and leadership knowledge sufficient to lead multiple job areas and influence others to accept practices and approaches.
• Excellent communication and presentation skills.
• Business development experience.
• Ability to accurately perceive speech during extensive telephone and face-to-face communication.
• Ability to perform repetitive finger motions associated with extensive keyboard use.
• Ability to sit regularly for extended periods.

Responsibilities

• Integrate strategic regulatory, statistical, and drug-development support into clinical-trial offerings for emerging biopharmaceutical companies.
• Interface with clients through the Therapeutic Science & Strategy Unit Centres of Excellence to provide strategic advice and regulatory and statistical guidance.
• Support customer engagements with regulatory authorities, including the FDA and EMA, across drug development from preclinical development through licensing, including contributing to briefing documents and meeting materials.
• Support emerging science and innovation in novel trial offerings, including digital twins.
• Advise on innovative compound development to maximize technical, regulatory, and commercial success, including contributing to Target Product Profiles, Clinical Development Plans, clinical study designs, synopses, and protocols as appropriate.
• Provide strategic leadership for regulatory submissions, including INDs, NDAs, BLAs, MAAs, and applications for special designations such as orphan drug, pediatric, fast-track, and breakthrough status.
• Ensure deliverables are high-quality, well-reasoned, objective, data-driven where appropriate, and consistent with high standards of medical, ethical, and scientific integrity and conduct.
• Assume customer senior-management roles as requested, including membership in virtual cross-functional drug-development teams.
• Provide regulatory strategy expertise for strategic business activities and investment opportunities.
• Assist in developing programs to maximize organizational growth and profitability.
• Work with senior management, CRO operations, therapeutic units, and other operations heads to support customer satisfaction and provide effective strategic consultancy.
• Provide internal and external education on strategic regulatory, statistical, and pharmaceutical-development topics in support of IQVIA business units.
• Attend scientific meetings and conferences, follow relevant publications, and maintain awareness of scientific developments and progress in regulatory strategy.
• Represent IQVIA or a partner at meetings as appropriate.
• Develop and maintain relationships with pharmaceutical and biotechnology companies and key opinion leaders.
• Support organizational policy initiatives.
• Comply with business-office requirements for tracking time and effort.

Benefits

• Health and welfare benefits may be offered, depending on the position.
• Incentive plans, bonuses, and/or other forms of compensation may be offered, depending on the position.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior