Senior Director, Drug Development

IQVIA•Durham, NC

1d•Remote

About The Position

Manages a department or small unit. Provides 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.). Provides medical, clinical, scientific, regulatory, and product development leadership and consultancy expertise to support strategic business activities and investment opportunities. Participates in all aspects of Strategic Drug Development and leads the implementation of mission, goals and objectives, development of policies, procedures and standards for the department. Provides 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.

Requirements

Masters degree or higher or the equivalent combination of education, training and experience.
Typically requires 15-20+ years relevant clinical research experience with multi-regional and global focus including significant experience in senior strategic role.
Requires broad management and leadership knowledge to lead multiple job areas, the ability to influence others to accept practices and approaches.
Expertise in Excel and PowerPoint.
Strong strategic thinking, analytical and communication skills and ability to thrive in a culture of achievement.
Client-focused and consultative approach for project management - not just an order taker but is able to suggest alternate approaches and provide strategic insights that meet client needs.
Demonstrates a strong command of a variety of analytical and market research techniques.
Sought out by clients (internal and external) as an analytical expert and, more importantly, as a strategic advisor.
Grasps key issues quickly, understands the "big picture", and links market research insights to larger business issues relevant to client needs.
Demonstrates excellent written and verbal communication skills and is effective in a variety of presentation settings.
Has a strong commitment to quality.
Has a proven track record of meeting or exceeding goals.
Has broad management knowledge to lead teams and leadership knowledge to lead multiple job areas.
Has ability to influence others to accept practices and approaches.

Responsibilities

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 companies, key opinion leaders identify new business opportunities.
Compliance with all business office requirements for tracking time and effort.