Senior Director, 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 href="https://jobs.iqvia.com/">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

  IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

  The potential base pay range for this role, when annualized, is $186,300.00 - $519,000.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.