Job Details

SciPro is currently partnered with a well-funded, late-stage Oncology Biotech developing novel targeted oncology therapies. They are seeking a leader with extensive Oncology experience to help shape strategy, guide portfolio execution, and partner across the organization as they move towards submissions and product launch.

They are focused on improving the outcomes in high unmet need for solid tumors such as lung, pancreatic, and colorectal cancers, with the goal of delivering next-generation targeted therapies where existing treatments have limited durability. They are growing to keep up with the demand of their progressing clinical trials as they move towards the goal of approval and launch.

They are currently hiring for an Executive Director Global CMC Lead position. You will serve as a highly senior CMC leader responsible for leading late-stage programs toward commercialization. You will be accountable for CMC timelines, risks and deliverables. Additionally, you will provide strategic oversight of drug substance development, drug product, specification and control strategy development, and lifecycle optimization. You will also anticipate and proactively manage CMC risks impacting development speed, regulatory success or supply robustness.

Main Responsibilities:

• Own the integrated global CMC strategy across assigned development and commercial programs
• Drive clear, risk-based CMC decision-making that balances speed, quality, and long-term product robustness.
• Provide strategic oversight of drug substance development and manufacturing, drug product development and manufacturing, specification and control strategy development, and lifecycle optimization.
• Partner with PDM cross-functional team / leadership to
• define global CMC regulatory strategy for IND/CTA, NDA/MAA, JNDA and post-approval lifecycle activities.
• to ensure technical readiness for late-stage development, PPQ, validation, and commercial supply, capacity planning, risk mitigation, dual sourcing as needed, and launch readiness, as well as life cycle development.
• Ensure all CMC Activities meet global GMP, ICH and regulatory expectations
• Manage a large cross-functional team, as well as direct reports (number unknown right now, as this is a brand new team growing!)

Qualifications:

• Seeking an PhD-level executive director with 15+ years of CMC experience in Pharma/Biotech primarily focused on small molecules
• Has worked with small molecules
• Experience in large pharma (some biotech is okay!)
• Experince with global regulatory submissions
• Accelerating first-in-class programs
• Late-stage clinical experience (Phase II, III and post commercialization)
• Has led/managed a cross functional team
• Oncology experience (preferred)