SVP, Pharmaceutical Sciences
BioCryst Pharmaceuticals, Inc.
4 months ago
Remote friendly (North Carolina, United States)
United States
Operations
Job Summary
The SVP of Pharmaceutical Sciences (Pharm Sci) is responsible for PharmSci 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.
Essential Duties & Responsibilities
- Align project priorities, coordinate PharmSci activities, project deliverables and resources between PharmSci and other developmental functions.
- Mentor and develop a high-performing PharmSci 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 PharmSci plans.
- Serve on Technical Operations leadership team; contribute to enterprise operational strategy, governance, and execution.
- Create, maintain, and curate the PharmSci technology roadmap across biologics and small molecules.
- Oversee PharmSci technology transfers and process validation readiness with Technical Operations for drug substance and drug product at contract manufacturing organizations.
- Perform risk assessments for strategic PharmSci decisions; approve risk level and mitigation.
- Review/approve PharmSci and GMP-related submission documents for regulatory compliance.
- Drive scientific rigor, operational excellence, and continuous improvement with internal teams and external partners.
- Accountable for PharmSci budget and financial performance.
- Participate/advice in HR leadership development programs for PharmSci personnel.
- Lead, mentor direct reports and junior PharmSci staff.
- Oversee CRO and contract manufacturing selection process (with Tech Ops leadership).
- Own PharmSci content of INDs, NDAs, and BLAs.
Experience & Qualifications / Skills
- 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 PharmSci 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).
The SVP of Pharmaceutical Sciences (Pharm Sci) is responsible for PharmSci 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.
Essential Duties & Responsibilities
- Align project priorities, coordinate PharmSci activities, project deliverables and resources between PharmSci and other developmental functions.
- Mentor and develop a high-performing PharmSci 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 PharmSci plans.
- Serve on Technical Operations leadership team; contribute to enterprise operational strategy, governance, and execution.
- Create, maintain, and curate the PharmSci technology roadmap across biologics and small molecules.
- Oversee PharmSci technology transfers and process validation readiness with Technical Operations for drug substance and drug product at contract manufacturing organizations.
- Perform risk assessments for strategic PharmSci decisions; approve risk level and mitigation.
- Review/approve PharmSci and GMP-related submission documents for regulatory compliance.
- Drive scientific rigor, operational excellence, and continuous improvement with internal teams and external partners.
- Accountable for PharmSci budget and financial performance.
- Participate/advice in HR leadership development programs for PharmSci personnel.
- Lead, mentor direct reports and junior PharmSci staff.
- Oversee CRO and contract manufacturing selection process (with Tech Ops leadership).
- Own PharmSci content of INDs, NDAs, and BLAs.
Experience & Qualifications / Skills
- 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 PharmSci 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).