R&D Product Development Director

Job title: R&D Product Development Director

About the Role The R&D Product Development Director leads end-to-end strategy and execution of pharmaceutical drug product development with a focus on innovative injectable dosage forms. You will oversee programs from concept through commercial launch, ensuring scientific rigor, regulatory compliance, and alignment with enterprise growth objectives. This role requires deep scientific expertise across complex formulations, CMC strategy, analytical and bioanalytical testing, combined with strong business acumen and cross-functional leadership. American Regent celebrates diversity and is an Equal Opportunity Employer.

What You'll Do

• Lead development and execution of comprehensive pharmaceutical development strategies, ensuring all R&D programs meet global regulatory standards and corporate objectives.
• Oversee preparation, review, and approval of critical pharmaceutical development documentation, including Technical Transfer Documents, Product Development Reports (PDRs), CMC sections, and regulatory submission materials supporting clinical, registration, and commercial batches.
• Apply Quality by Design (QbD) principles and risk-based methodologies to accelerate development timelines while maintaining scientific excellence and compliance.
• Serve as the scientific authority in Portfolio Management Committee meetings, providing technical leadership and strategic input for NDAs, 505(b)(2) applications, ANDAs, and NADAs.
• Maintain expert-level knowledge of parenteral drug delivery technologies and relevant patent landscapes; proactively contribute to intellectual property strategy and differentiation initiatives.
• Develop and execute long-term R&D strategies aligned with corporate growth objectives and emerging industry trends in injectable and complex dosage forms.
• Identify and advance 505(b)(2) opportunities to create differentiated, value-added formulations for both new and existing products.
• Partner with Development, Medical, Commercial, Regulatory, and Manufacturing teams to build a commercially viable and strategically differentiated product pipeline.
• Contribute to the Scientific Affairs leadership team by shaping and executing the mission, vision, and operational priorities of the R&D organization.
• Recruit, mentor, and lead a high-performing technical organization focused on complex generics, First-to-File (FTF), and First-to-Launch (FTL) parenteral products.
• Establish and champion robust talent development and succession planning processes, fostering a culture of accountability, innovation, and continuous professional growth.
• Perform any other tasks/duties as assigned by management.

What We're Looking For

• Ph.D. in Life Sciences (Chemistry or Pharmaceutical Science concentration) required.
• Minimum of 10 years in formulation, analytical, and process development with a proven track record with complex molecules, including solutions, lyophilized products, suspensions, and novel drug delivery platforms.
• 7+ years of demonstrated leadership experience managing a team.
• Deep understanding of the drug discovery lifecycle and global regulatory requirements; startup biotech experience a plus.
• Exceptional technical writing and interpersonal skills; ability to influence at the executive level.
• Excellent oral and written communication skills.
• Ability to prioritize and perform multiple tasks simultaneously; ability to make decisions independently with appropriate input.
• Ability to work well in a matrix environment, particularly with QA/QC, Manufacturing Operations, Project Management and Regulatory Affairs.
• Flexibility in adapting to multiple therapeutic areas and/or projects interchangeably.
• Strong computer skills (Word, Excel, PowerPoint, Outlook).

Nice to Have

• Experience in a start-up biotech environment and familiarity with advanced drug development platforms would be a plus.