Nature and Scope
The R&D Product Development Director is a pivotal leadership role responsible for the end-to-end strategy and execution of pharmaceutical drug product development, with a primary focus on innovative injectable dosage forms. This role oversees programs from ideation through commercial launch, ensuring scientific rigor, regulatory compliance, and alignment with enterprise growth objectives.
This position requires deep scientific expertise across complex formulations, CMC strategy, analytical and bioanalytical testing, combined with strong business acumen and cross-functional leadership. The Director serves as a key strategic partner in advancing the company’s portfolio, collaborating closely with Portfolio Management, Clinical, Regulatory Affairs, Manufacturing, and Commercial teams to optimize execution, accelerate development timelines, and pioneer differentiated drug delivery solutions.
Essential Duties and Responsibilities
Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
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Lead the development and execution of comprehensive pharmaceutical development strategies, ensuring all R&D programs meet global regulatory standards and corporate objectives.
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Oversee the 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.
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Apply Quality by Design (QbD) principles and risk-based methodologies to accelerate development timelines while maintaining scientific excellence and compliance.
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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.
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Maintain expert-level knowledge of parenteral drug delivery technologies and relevant patent landscapes; proactively contribute to intellectual property strategy and differentiation initiatives.
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Develop and execute long-term R&D strategies aligned with corporate growth objectives and emerging industry trends in injectable and complex dosage forms.
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Identify and advance 505(b)(2) opportunities to create differentiated, value-added formulations for both new and existing products.
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Partner with Development, Medical, Commercial, Regulatory, and Manufacturing teams to build a commercially viable and strategically differentiated product pipeline.
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Contribute to the Scientific Affairs leadership team by shaping and executing the mission, vision, and operational priorities of the R&D organization.
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Recruit, mentor, and lead a high-performing technical organization focused on complex generics, First-to-File (FTF), and First-to-Launch (FTL) parenteral products.
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Establish and champion robust talent development and succession planning processes, fostering a culture of accountability, innovation, and continuous professional growth.
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Perform any other tasks/duties as assigned by management.
Education Requirements and Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.
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Ph.D. in Life Sciences (Chemistry or Pharmaceutical Science concentration) required.
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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.
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7+ years of demonstrated leadership experience managing a team.
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Deep understanding of the drug discovery lifecycle and global regulatory requirements. Experience in a start-up biotech environment and familiarity with advanced drug development platforms would be a plus.
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Exceptional technical writing and interpersonal skills; ability to influence at the executive level.
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Excellent oral and written communication skills.
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Ability to prioritize and perform multiple tasks simultaneously.
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Ability to make decisions independently and with appropriate input.
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Ability to work well in a matrix environment, particularly with QA/QC, Manufacturing Operations, Project Management and Regulatory Affairs.
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Flexibility in adapting to multiple therapeutic areas and/or projects interchangeably.
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Strong computer skills (Word, Excel, PowerPoint, and Outlook).
American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.
Applicants have rights under Federal Employment Laws.
FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf
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Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf
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