Exec. Director, Pharmaceutical Development

Discover an exciting opportunity to lead the advancement of innovative small-molecule therapies in a dynamic biopharmaceutical environment focused on cancer and immune disorders. You will have the chance to make a meaningful impact by guiding late-phase drug product development from clinical trials through to commercial launch, working with cutting-edge platform technologies that target key cellular processes.

Our client is a growing biopharmaceutical company dedicated to discovering and developing novel treatments that modulate cellular protein levels. Their research leverages proprietary libraries and integrated platforms to identify and advance targeted drug candidates, primarily focusing on highly innovative approaches to disease treatment.

In this key leadership role, you will oversee the technical and strategic aspects of oral solid drug product manufacturing, ensuring seamless transitions from development to commercialization. You will collaborate with internal teams and external contract manufacturing organizations (CMOs) to deliver high-quality drug products while maintaining compliance with regulatory standards.

Role Summary

You will provide expert scientific and operational leadership throughout late-stage development, influencing the entire process from process development to regulatory submissions. Your work will support the company’s pipeline and commercial efforts, playing a crucial role in bringing novel therapies to patients. The position involves a mix of onsite management, strategic planning, and cross-functional collaboration.

Key Responsibilities

• Lead technical activities at drug product CMOs, including technology transfer, process troubleshooting, and process validation.
• Drive successful coordination between internal teams and external partners to ensure timely manufacture and release of drug product lots.
• Support regulatory activities by preparing and reviewing documentation such as CMC sections for filings.
• Oversee process development activities in alignment with principles of Quality by Design, including risk assessments and studies.
• Collaborate with chemical and analytical teams to optimize drug substance properties and control strategies.
• Maintain compliance with regulatory standards, including FDA, EMA, ICH, GCP, and GMP.
• Provide technical mentorship to team members and promote a collaborative, results-driven environment.

Experience & Requirements

• Ph.D. in chemistry, pharmaceutical sciences, engineering, or related field with at least 10 years (or M.S. with at least 15 years) of industry experience in late-phase small-molecule drug development.
• Extensive expertise in GMP manufacturing of oral solid dose forms, including formulation, process development, scale-up, and validation.
• Proven experience managing third-party drug product CMOs, including tech transfer and commercialization activities.
• Strong knowledge of regulatory guidelines and experience in preparing regulatory documentation.
• Excellent communication, problem-solving, and leadership skills.
• Ability to manage multiple projects in a fast-paced environment with a hands-on, resourceful approach.
• Willingness to travel up to 25%.