IQVIA

Senior Director, Regulatory Strategy and Drug Development

IQVIA • $186K — $500K+*
Durham, NC 27713In-Person
Pharmaceuticals & Biotech
11 - 15 years of experience
Reposted Today
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Job Overview by Ladders

Qualifications

  • Master's degree or higher, or equivalent education/experience
  • 15-20+ years of relevant clinical research experience, particularly in senior strategic roles
  • Significant leadership and management experience across multiple job areas
  • Expertise in Excel and PowerPoint
  • Strong strategic, analytical, and communication skills
  • Client-focused with a consultative approach to project management
  • Demonstrated command of various analytical and market research techniques
  • Excellent written and verbal communication skills with impactful presentation abilities

Responsibilities

  • Evaluate and develop comprehensive product development strategies for pharmaceuticals
  • Support regulatory engagements and contribute to essential documentation for client meetings
  • Lead risk assessments and develop mitigation strategies for drug development candidates
  • Support innovative compound development to maximize regulatory and commercial success
  • Oversee development and submission of regulatory documents including INDs and NDAs
  • Ensure high-quality, objective deliverables adhering to medical and scientific integrity
  • Engage in business development activities and maintain relationships with pharmaceutical companies and opinion leaders

Benefits

  • Home-based work flexibility in the USA/Europe
  • Professional development opportunities through scientific conferences and webinars
  • Access to internal and external educational resources in drug development
  • Engagements with key opinion leaders and clients for strategic insights
  • Opportunity to influence and lead in the global pharmaceutical landscape
Full Job Description
Job Level: Senior Director, Regulatory Strategy and 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 regulatory strategies for drug development, IND and marketing approval, product lifecycle management and portfolio management, particularly focused on emerging biopharmaceutical company customer goals in oncology. Provides strategic regulatory advice towards efficient clinical development and navigation of US & European regulatory frameworks. Responsible for the development of regulatory business, in accordance with DDRS and Corporate business plans. Participates in project-related work, as necessary. Provide scientific, regulatory, and product development leadership and consultancy expertise to support strategic business activities and investment opportunities. Provide thought leadership in regulation of bio-pharmaceutical products by preparing publications, white papers, and blogs in areas of expertise and by participating in scientific conferences and webinars, as appropriate.

Essential Functions:
  • 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...)
  • 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 and develop a global regulatory team, including line management activities.
  • Support 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.
  • 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 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.
  • 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.
  • 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 DDRS
  • 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


Qualifications:
  • 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.


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About IQVIA

Innovex offers superior and creative advice to corporations. In addition, they raised venture capital for our own affiliate companies, in addition to having assisted clients in fund-raising efforts, new venture outreaches, and financing. Their engineers and technical staff offer varied backgrounds in manufacturing, high tech, product design, quality control, safety, biomechanics, and robotics.

IQVIA Careers

Join the vibrant team at IQVIA, a leading global provider of advanced analytics, technology solutions, and clinical research services to the healthcare industry. IQVIA is recognized for its commitment to innovation, leadership in healthcare, and a culture that celebrates diversity and inclusion.

Work You’ll Do

At IQVIA, we offer job opportunities that empower you to leverage your skills and drive healthcare forward. Become part of a team that thrives on innovation and the pursuit of operational excellence, helping to improve patient outcomes across the globe.

Transform Your Career

IQVIA is the place where you can transform the world of healthcare while advancing your career. With a variety of positions available, from research and development to business analytics, IQVIA is at the forefront of the industry. Our leadership is committed to fostering a culture of growth and professional development, making IQVIA a prime environment for both seasoned professionals and those seeking an internship to kickstart their career.

Innovative Work Environment

Join over 50,000 dedicated professionals in a dynamic environment where technology meets healthcare. At IQVIA, innovation isn’t just a buzzword; it's the backbone of how we solve complex challenges. With cutting-edge resources and a collaborative global team, your work at IQVIA directly contributes to advancements in life sciences.

Career Development and Benefits

IQVIA believes in nurturing its team members not just as employees but as individuals seeking to grow their careers. We support this with unmatched benefits, diversity training, and opportunities for leadership development. Our commitment to your career growth is matched by our dedication to providing a supportive and inclusive workplace.

Explore Job Opportunities

Whether you’re looking for a full-time position, part-time work, or a graduate internship, IQVIA offers a range of employment options to match your career ambitions. Our hiring process is designed to be transparent and engaging, helping you to understand where your skills can best be utilized within the company.

Networking and Professional Development

At IQVIA, networking and professional development are part of our DNA. Engage with industry leaders, participate in global conferences, and take advantage of our in-house training programs designed to enhance your skills and advance your career.

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Join Our Team Search open positions that match your skills and interests. We look for passionate, curious, creative, and solution-driven team players. Explore the diverse job opportunities at IQVIA and find where you can make an impact.

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Personalize your subscription to receive job alerts, latest news, and insider tips tailored to your preferences. Discover the exciting and rewarding career opportunities that await at IQVIA. Embark on a journey of growth, innovation, and leadership at IQVIA. Shape your future in an environment that values diversity and fosters professional development. Join IQVIA today and transform healthcare through the power of information and technology.
Learn more about IQVIA
Size
82,000 employees
Market Cap
$37.5 billion
Industry
Pharmaceuticals & Biotech
Net Income
$279 million
Founded
2016
5 Year Trend
+15.3%
Revenue
$11.3 billion
NASDAQ
IQV
* Ladders Estimates

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