CMC Strategy Director: Preclinical to Clinic

Real Staffing Group; Boston (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

Real Staffing Group is seeking an experienced CMC leader to drive cross-functional development from preclinical through early clinical stages. The role will lead strategy across drug substance and product, overseeing external CDMOs and partners while collaborating with Regulatory, Quality, Nonclinical, and Clinical teams.

Qualified candidates will have significant biotech/pharma CMC experience and a track record advancing programs from preclinical to early clinical development.

Qualifications

• BS, MS, or PhD in a relevant scientific discipline.
• Significant biotechnology/pharma industry experience in CMC development.
• Experience with modalities including oligonucleotides, siRNA, ASO, peptides, biologics, or related platforms.
• Strong track record managing external partners and global development activities.
• Experience advancing programs from preclinical through early clinical development.
• Excellent leadership, communication, and cross-functional collaboration skills.

Responsibilities

• Lead CMC strategy and execution across drug substance and drug product development.
• Manage external CDMOs, manufacturing, analytical, and process development partners.
• Partner with Regulatory, Quality, Nonclinical, and Clinical teams to achieve milestones.
• Drive project timelines, budgets, risk management, and operational execution across multiple programs.
• Support IND-enabling activities and early-stage clinical development.

Skills

Leadership

Cross-functional collaboration

Project management

Strategic CMC planning

External partner management

Regulatory interaction

Education

BS/MS/PhD in a relevant scientific discipline

Tools

External CDMOs management

Job description

Real Staffing Group is seeking an experienced CMC leader to drive cross-functional development from preclinical through early clinical stages. The role will lead strategy across drug substance and product, overseeing external CDMOs and partners while collaborating with Regulatory, Quality, Nonclinical, and Clinical teams.

Qualified candidates will have significant biotech/pharma CMC experience and a track record advancing programs from preclinical to early clinical development.