Senior Director, Drug Development

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Oversees a department or a small unit.

• Offers leadership and guidance in formulating optimal strategies for drug development, product lifecycle management, and portfolio management to align with the objectives of pharmaceutical and biotechnology clients (including strategic oversight of clinical development plans, go/no-go decisions, in-licensing, out-licensing, and expediting time to market).

• Provides medical, clinical, scientific, regulatory, and product development leadership and consulting expertise to aid strategic business initiatives and investment prospects.

• Engages in all facets of Strategic Drug Development and spearheads the execution of mission, goals, and objectives, along with the formulation of policies, procedures, and standards for the department.

• Contributes thought leadership in pharmaceutical product development by drafting publications, white papers, and blogs in areas of expertise and by actively participating in scientific conferences and webinars, as appropriate.

• Assesses and formulates product development strategies for pharmaceutical products (drugs, biologics, advanced therapies) that emphasize clinical-commercial alignment and cover all development phases from discovery to market, including preclinical strategy, clinical strategy, regulatory strategy, and commercial strategy.

• Facilitates interactions with regulatory bodies (e.g., FDA, EMA) on behalf of clients, throughout the drug development lifecycle from preclinical stages to licensing, including contributions to briefing documents and meeting materials, as well as attendance and participation in meetings and other engagements.

• Directs evaluations of risk and likelihood of regulatory success, developing mitigations for candidate pharmaceutical products, including providing regulatory input for indication prioritization exercises, development strategy assessments, gap analyses, due diligence, and related activities.

• Promotes the innovative development of compounds to enhance technical, regulatory, and commercial outcomes, contributing to the creation of Target Product Profiles (TPPs), Clinical Development Plans (CDPs), clinical study designs, synopses, and protocols, as relevant.

• Provides strategic leadership in the preparation of regulatory submissions, including INDs, marketing/licensing authorizations (NDA/BLA/MAAs), and special designations (orphan drugs, pediatric plans, “fast-track”, “break-through”, etc.).

• Guarantees high-quality, well-reasoned, objective outputs (utilizing data-driven designs, where applicable) that uphold the highest standards of medical, ethical, and scientific integrity and conduct.

• Takes on the role of customer senior management as required, including participation in virtual cross-functional drug development teams.

• Delivers drug development expertise to bolster strategic business activities and investment opportunities.

• Aids in creating programs to enhance the organization's growth and profitability.

• Ensures Customer Satisfaction by collaborating closely with Senior Management, CRO Operations, Therapeutic Units, and other Operations Leaders to provide optimal strategic consultancy to clients.

• Acts as a key resource and engages in strategic business development efforts including presentations to potential clients, attendance at professional meetings, or other business development initiatives for IQVIA Strategic Drug Development.

• Offers internal and external educational services related to therapeutic and pharmaceutical development in support of all branches of IQVIA's operations.

• Participates in key scientific meetings/conferences and stays informed of relevant scientific literature to maintain awareness of current scientific advancements and progress in drug development methodologies.

• Cultivates and sustains relationships with pharmaceutical and biotechnology firms, key opinion leaders, and identifies new business opportunities.

⛳️ Requirements

• A Master’s degree or higher, or an equivalent combination of education, training, and experience.

• Generally requires 15-20+ years of pertinent clinical research experience with a multi-regional and global focus, including substantial experience in a senior strategic role.

• Requires comprehensive management and leadership knowledge to oversee multiple job areas, along with the ability to persuade others to adopt practices and approaches.

• Proficiency in Excel and PowerPoint.

• Strong strategic thinking, analytical, and communication skills with the ability to excel in a results-oriented culture.

• Client-focused and consultative approach to project management—not merely an order taker, but capable of suggesting alternative strategies and providing strategic insights that fulfill client needs.

• Recognized by clients (both internal and external) as an analytical expert and, more importantly, a strategic advisor.

• Quickly comprehends key issues, understands the broader context, and connects market research insights to larger business challenges relevant to client needs.

• Exhibits excellent written and verbal communication skills and is effective in diverse presentation environments.

• Demonstrates a strong commitment to quality.

• Possesses a proven track record of meeting or surpassing goals.

• Holds broad management knowledge to lead teams and possesses leadership acumen to manage multiple job areas.

• Capable of influencing others to embrace practices and methods.

🏝️ Benefits

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