SVP, Pharmaceutical Sciences

Job Summary

The SVP of Pharmaceutical Sciences (Pharm Sci) is responsible for Pharm Sci strategy and execution across both biologics and small molecules, including drug substance and drug product development, clinical supplies, scale-up and technology transfer, and analytical development.

• Align project priorities, coordinate Pharm Sci activities, project deliverables and resources between Pharm Sci and other developmental functions.
• Mentor and develop a high-performing Pharm Sci leadership team across functional areas.
• Collaborate with cross-functional areas to ensure project progress to agreed timelines, especially research and discovery.
• Work with Clinical, Quality, Regulatory, Technical Operations, Preclinical, and Finance to develop and execute Pharm Sci plans.
• Serve on Technical Operations leadership team; contribute to enterprise operational strategy, governance, and execution.
• Create, maintain, and curate the Pharm Sci technology roadmap across biologics and small molecules.
• Oversee Pharm Sci technology transfers and process validation readiness with Technical Operations for drug substance and drug product at contract manufacturing organizations.
• Perform risk assessments for strategic Pharm Sci decisions; approve risk level and mitigation.
• Review/approve Pharm Sci and GMP-related submission documents for regulatory compliance.
• Drive scientific rigor, operational excellence, and continuous improvement with internal teams and external partners.
• Accountable for Pharm Sci budget and financial performance.
• Participate/advice in HR leadership development programs for Pharm Sci personnel.
• Lead, mentor direct reports and junior Pharm Sci staff.
• Oversee CRO and contract manufacturing selection process (with Tech Ops leadership).
• Own Pharm Sci content of INDs, NDAs, and BLAs.

• PhD in science or engineering (or equivalent education and experience).
• 15+ years’ experience in all phases of drug development of oral and sterile products (preferably industrial).
• Experience overseeing manufacture of clinical supplies for global clinical studies.
• Experience preparing multiple US/global applications (IND, IMPD, NDA, BLA).
• Breadth across biologics and small molecules; end-to-end Pharm Sci leadership from early development through commercial readiness.
• Proven matrix partnering across Research, Clinical, Regulatory, Quality, and Technical Operations.
• Experience identifying CROs and contract manufacturing organizations.
• Knowledge of cGMP manufacturing regulatory requirements.
• Ability to solve problems using judgment, experience, and outside consultants.
• Exceptional oral/written communication and presentation skills.
• Strong knowledge of US and global regulatory requirements and guidelines (e.g., FDA, EMA, PMDA, Moksha8, KFDA, ICH).