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 in Bio Cryst
• Mentor and develop a high performing Pharm Sci leadership team that efficiently coordinates activities across different Pharm Sci functional areas.
• Maintain seamless collaboration with other functional areas of the organization to ensure project progress according to agreed timelines especially research and discovery.
• Work closely with Clinical, Quality, Regulatory, Technical Operations, Preclinical and Finance functions in the company in the development and execution of Pharm Sci plans to meet corporate objectives.
• Serve as a member of the Technical Operations leadership team, contributing to enterprise operational strategy, governance, and execution.
• Create, maintain, and curate the Pharm Sci technology roadmap across biologics and small molecules to guide platform capabilities, externalization strategy, and investment priorities.
• Oversee and facilitate Pharm Sci technology transfers and process validation readiness in collaboration with Technical Operations to support manufacturing for drug substance and drug product at contract manufacturing organizations.
• Perform risk assessments for strategic Pharm Sci decisions, approve appropriate level of risk and mitigation for significant issues as required.
• Review and approve Pharm Sci and GMP related submission documents to assure compliance with regulatory standards and ensure their suitability for regulatory submissions.
• Drive a culture of scientific rigor, operational excellence, and continuous improvement across Pharm Sci functional teams and external partners.
• Accountable for overall budget and financial performance of the Pharm Sci organization.
• Participate and advice in the HR initiated leadership development programs for Pharm Sci personnel
• Lead, mentor direct reports and junior Pharm Sci staff members
• Oversee Contract Research Organizations (CRO) and Contract Manufacturing selection process in collaboration with the Tech Ops Leadership Team
• Responsible for the Pharm Sci content of INDs, NDAs, and BLAs.

• PhD in science or engineering or an equivalent combination of education and experience.
• Minimum of 15+ years’ experience in all phases of drug development of oral and sterile products, preferably gained in an industrial setting.
• Experience on overseeing manufacture of clinical supplies for global clinical studies.
• Experience with the preparation of multiple US and global applications (IND, IMPD, NDA, and BLA).
• Demonstrated breadth of experience across modalities, including biologics and small molecules, with end-to-end Pharm Sci leadership from early development through commercial readiness.
• Track record of partnering effectively across Research, Clinical, Regulatory, Quality, and Technical Operations in a matrix environment to deliver robust, compliant Pharm Sci packages and supply strategies for global development programs.
• Experience in identifying appropriate CRO and contract manufacturing organizations.
• Experience and knowledge of the regulatory requirements for manufacturing in a cGMP environment.
• Ability to solve problems using personal judgement, experience, and outside consultants.
• Exceptional oral and written communication and presentation skills.
• Strong knowledge of US and global requirements and associated guidelines required for drug development (e.g. FDA, EMA, PMDA, Moksha8, KFDA and ICH).

The statements in this position description are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The manager may assign additional responsibilities and assignments from time to time.

Bio Cryst is an equal opportunity employer and is committed to providing equal employment opportunities without regard to age, race, religion, sex, sexual orientation, gender identity, national origin, Veterans status, disability and/or other protected class characteristics. Additionally, Bio Cryst is committed to achieving its business objectives in compliance with all federal, state and local law.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

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