Senior Director, Regulatory Strategy Leader-Oncology

Job Overview-

Provide leadership and advice on the development of optimum regulatory and biostatistical strategies for drug development, product lifecycle management and portfolio management, particularly focussed on emerging biopharmaceutical company customer goals. Provides strategic regulatory and biostatistical advice towards efficient clinical development and navigation of US & European regulatory frameworks. Minimal participation in project-related work, as necessary as a subject matter expert. Provide scientific, regulatory, and product development leadership and consultancy expertise to support strategic business activities and investment opportunities. Support policy initiatives around the organization. Provide thought leadership by participation in publications, white papers, and blogs in areas of expertise and by participating in scientific conferences and webinars, as appropriate. Provide leadership in emerging novel trial designs/tools like digital twins in which the organization is heavily investing

Essential Functions-

• Integrate strategic regulatory, statistical & drug development support services into emerging biopharmaceutical company clinical trial offerings. Interface with clients as part of the Therapeutic Science & Strategy Unit Centres of Excellence to provide strategic advice and incorporate regulatory and statistical guidance.

• 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.

• Support the emerging science and innovation around novel trial offerings including digital twins.

• 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, pediatics 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, statistical 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.

• Support policy initiatives within the organization

• Compliance with all business office requirements for tracking time and effort.

Qualifications-

• Bachelor’s Degree required or equivalent experience
• 15+ years of relevant clinical research experience and/or regulatory experience with multi regional and global focus including significant experience in strategic role.
• Required Broad Management and leadership knowledge to lead multiple job areas, the ability to influence others to accept practices and approaches.
• Excellent communication and presentation skills.
• Business Development Experience
• Extensive use of telephone and face-to-face communication require accurate perception of speech
• Extensive use of keyboard requiring repetitive motion of finger
• Regular sitting for extended periods of time

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

…