SVP, Pharmaceutical Sciences

COMPANY:

At BioCryst, we share a deep commitment to improving the lives of people living with hereditary angioedema (HAE) and other rare diseases. We leverage our expertise in structure-guided drug design to develop first-in-class or best-in-class oral small-molecule and injectable protein therapeutics, led by the efforts of our team of expert scientists in our Discovery Center of Excellence in Birmingham, Alabama. Our global headquarters is in Durham, North Carolina and our employees span the globe across sites in multiple countries. We are proud of our culture of engagement and accountability that rewards people for innovative thinking and achievement of key objectives. For more information, please visit our website at www.biocryst.com  or follow us on LinkedIn and Instagram.

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 in BioCryst
• Mentor and develop a high performing PharmSci leadership team that efficiently coordinates activities across different PharmSci 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 PharmSci 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 PharmSci technology roadmap across biologics and small molecules to guide platform capabilities, externalization strategy, and investment priorities.
• Oversee and facilitate PharmSci 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 PharmSci decisions, approve appropriate level of risk and mitigation for significant issues as required.
• Review and approve PharmSci 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 PharmSci functional teams and external partners.
• Accountable for overall budget and financial performance of the PharmSci organization.
• Participate and advice in the HR initiated leadership development programs for PharmSci personnel
• Lead, mentor direct reports and junior PharmSci staff members
• Oversee Contract Research Organizations (CRO) and Contract Manufacturing selection process in collaboration with the Tech Ops Leadership Team
• Responsible for the PharmSci content of INDs, NDAs, and BLAs.

EXPERIENCE & QUALIFICATIONS:

• 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 PharmSci 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 PharmSci 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.

BioCryst 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, BioCryst is committed to achieving its business objectives in compliance with all federal, state and local law.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.