Director of Product Development

Responsibilities

Strategic Leadership and Direction:

• Oversee the end-to-end development of injectable drug products from concept to commercialization.
• Set strategic goals, priorities, and timelines for the drug product development team.
• Collaborate with cross-functional teams, including R&D, regulatory, manufacturing, and quality assurance, to ensure alignment on product goals.

Project Management:

• Lead multiple development projects, ensuring that milestones and deadlines are met.
• Allocate resources efficiently across projects, balancing team workloads and ensuring high-quality output.
• Monitor project progress and adjust strategies as needed to address challenges or delays.

Technical Oversight:

• Provide guidance on formulation development, process design, and scale-up activities.
• Ensure that product development follows industry best practices and complies with Good Manufacturing Practices (GMP).
• Review and approve technical documents, including protocols, reports, and specifications.

Regulatory Compliance:

• Ensure that all products are developed in compliance with relevant regulatory requirements (FDA, EMA, etc.).
• Support the preparation and review of regulatory submissions, including Investigational New Drug (IND) applications and New Drug Applications (NDA).
• Maintain an understanding of current regulatory trends and implement necessary adjustments in product development processes.

Innovation and Continuous Improvement:

• Drive innovation in injectable drug formulations, delivery systems, and manufacturing processes.
• Promote continuous improvement initiatives within the team to optimize development timelines and product quality.

Team Leadership and Development:

• Lead, mentor, and manage a team of engineers, providing guidance, technical support, and career development opportunities.
• Foster a collaborative and high-performance culture within the team.
• Conduct performance reviews, set individual and team objectives, and create development plans for staff.

Stakeholder Communication:

• Serve as the primary point of contact for internal and external stakeholders related to drug product development projects.
• Communicate project status, challenges, and opportunities to senior leadership.
• Build relationships with external partners, including contract manufacturers and research organizations.

Budget and Resource Management:

• Develop and manage the department's budget, including resource allocation for personnel, equipment, and external services.
• Track spending to ensure alignment with financial goals and project needs.

Risk Management:

• Identify potential risks in product development, including technical, regulatory, and operational risks.
• Develop risk mitigation strategies and contingency plans to address challenges in development.

Cross-Functional Collaboration:

• Collaborate with quality control, manufacturing, and supply chain teams to ensure smooth tech transfer and scale-up of products.
• Work closely with marketing and commercial teams to align development efforts with market needs and customer requirements.

Qualifications

• Bachelor's degree in Life Sciences, Engineering, Business Administration, or a related field (Master’s or Ph.D. preferred).
• Minimum of 10 years of experience in biotech or pharmaceutical program management, with an emphasis on supporting Clinical stage II and III programs. Minimum of 3 years’ experience in a team leadership role.
• Proven track record of successfully managing complex biotech programs, from early development through Clinical Phase III.
• Deep understanding of regulatory requirements and novel drug development processes in the biotech space.
• Exceptional leadership and communication skills with experience leading cross-functional teams.
• Ability to work in a fast-paced, dynamic environment with a focus on delivering results.