Senior Director, Regulatory Strategy and Drug Development

Job Level: Senior Director, 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 strategies for drug development, product lifecycle management and portfolio management to meet pharmaceutical and biotechnology customer goals (such as strategic leadership of clinical development plans, go/no go decisions, in-licensing, out-licensing, accelerated time to market, etc).; Provide medical, clinical, scientific, regulatory, and product development leadership and consultancy expertise to support strategic business activities and investment opportunities.; Participate in all aspects of Strategic Drug Development and lead the implementation of mission, goals and objectives, development of policies, procedures and standards for the department.

; Provide thought leadership in pharmaceutical product development by preparing publications, white papers, and blogs in areas of expertise and by participating in scientific conferences and webinars, as appropriate. Essential Functions: 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 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 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 drug development 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. 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 IQVIA Strategic Drug Development.

Provide internal and external therapeutic 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 drug development methodology As appropriate, represent IQVIA or the partner in such meetings.

Develop and maintain ongoing relationships with pharmaceutical and biotechnology c