Director, Process Optimization

SciPro is partnered with an exciting late-stage biotech that is seeking an experienced and forward-thinking professional to lead process optimization and continuous improvement initiatives, supporting the growth and operational excellence of a clinical research and development organization.

We are seeking an Director, Process Optimization with deep experience in streamlining business operations and optimizing cross-functional workflows within clinical research and development. This Director will be experience in designing and implementing efficient, scalable processes to enhance operational performance, reduce compliance risks, and support organizational growth. Additionally, we're looking for someone with a comprehensive understanding of the clinical drug development lifecycle and a proven track record in aligning diverse stakeholders to achieve strategic goals.

This is a hybrid position with 3 days onsite - the biotech has offices near San Bruno and Jersey City.

Responsibilities Include -

• Provide strategic direction in the development and improvement of operational frameworks supporting clinical R&D.
• Lead cross-functional efforts to create, update, and manage process documentation, workflows, and training resources.
• Collaborate with internal stakeholders to ensure process integration across the full spectrum of clinical development activities.
• Assess and refine existing processes to enhance scalability and maintain regulatory compliance.
• Identify inefficiencies and areas for improvement across current business practices.
• Utilize data tools and key metrics to assess process performance and support decision-making.
• Evaluate and define key performance indicators to track the success of process initiatives.
• Work closely with technical and operational teams on the design and implementation of clinical systems and tools.
• Partner with quality and compliance functions to ensure processes align with regulatory and organizational standards.
• Support readiness for inspections and audits by maintaining high-quality documentation and operational standards.
• Assist in the development and delivery of training and support materials for new systems or updated procedures.
• Stay current with regulatory trends and industry best practices to inform process enhancements.

Qualifications include -

• Over a decade of experience in clinical research and development, with a degree in life sciences or a related field.
• Background in biotech or pharmaceutical environments.
• Solid understanding of global regulatory requirements and clinical research standards.
• Demonstrated expertise in driving change through process innovation and system implementation.
• Strong interpersonal skills with the ability to influence and lead cross-functional initiatives.
• Analytical thinker with experience evaluating complex information to guide decision-making.
• Familiarity with clinical operations systems and platforms is advantageous.
• Excellent communication, documentation, and organizational skills.