VP, Global Drug Safety & PV

COMPANY:

At BioCryst, we share a deep commitment to improving the lives of people living with complement-mediated and other rare diseases. For over three decades we've been guided by our passion for not settling for "ordinary" in our quest to develop novel medicines. We leverage our expertise in structure-guided drug design to develop first-in-class or best-in-class oral small-molecule and 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, our European headquarters is in Dublin, Ireland 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 uson LinkedIn and Instagram.

JOB SUMMARY:

Reporting to the Chief Regulatory Officer, The VP, GDSP will be accountable for the overall functioning, compliance, effectiveness, business activities, and strategic direction of the BioCryst Pharmacovigilance Function. The VP will lead activities associated with clinical and post-marketing safety, ensuring compliance with all applicable regulations and the oversight of appropriate benefit risk assessment and risk management as pertains to safety risk. Specific areas of accountability are drug safety reporting (i.e. safety operations), safety signal detection and evaluation processes, and pharmacovigilance. In addition, the role will be accountable for the oversight and management of outsource partners handling day-to-day safety/pharmacovigilance activities. Safety department business activities including budgeting, staffing, process improvement, and departmental planning are also the accountability of the VP.

The VP will provide hands-on expertise to BioCryst's safety science function spanning the entire product lifecycle, assisting with safety monitoring planning, risk assessment, signal detection, assessment, and communication as a member of the Global Drug Safety Committee and Labeling Committee. The role will provide direct management of the safety science group (i.e. all medical directors and safety scientists in GDSP) and management of safety operations through the Executive Director, GDSP. #LI-Remote

ESSENTIAL DUTIES & RESPONSIBILITIES:

• Leads the global safety function and plans for growth and improvement of the department in keeping with corporate needs and regulatory requirements.
• Manages employees in the various functions within GDSP, either directly or via other managers, in order to ensure productivity, teamwork (internal and external), retention, and satisfaction.
• Ensures compliance with all applicable safety and PV regulations, GCP and GVP in all applicable territories.
• Supports and oversees safety operations and safety science. Accountable for the SOPs which govern all safety department procedures
• Aware of industry best practices and changes in global safety regulations and guidelines in order to optimize and upgrade all department policies, SOPs and systems, maintaining global compliance
• Leads and develops the method and extent to which GDSP integrates with (and supports) clinical development teams, to deliver proactive, integrated and comprehensive drug safety service during all phases of clinical development
• Provides advice to Product Teams on development of safety database and processes
• Develops an objective, defensible and medically sound Drug Safety view on product safety issues, supporting individual safety physicians
• Accountable for development and implementation of safety review processes, to ensure ongoing risk/benefit of all products
• Accountable for activities associated with the development and implementation of Post-marketing Surveillance Programs, including Risk Evaluation and Mitigation Strategies (REMS) when required, for marketed products
• Accountable for activities associated with the development and production within regulatory timelines of all required periodic safety reports such as DSURs, PBRERs, PSURs, and PADERs
• Provides safety input into clinical/regulatory documents such as Clinical Study Reports (CSRs), IND/NDA submissions, Risk Management Plans, Product Labeling and promotional materials
• Working with the Clinical Teams, coordinates activities regarding management of safety data to ensure compliance with relevant regulations and guidelines
• Identifies and evaluates external epidemiologic data sources as required
• Develops and oversees process for post-marketing surveillance and analysis

EXPERIENCE & QUALIFICATIONS:

• MD (or equivalent) and training/experience in relevant medical subspecialties is preferred but not required. Non-physicians may be considered if pharmacovigilance expertise is established, and all other criteria are otherwise met
• Experience in clinical research and drug development
• At least 10 years pharmaceutical experience or an equivalent combination of education and experience, with at least 5 years in pharmacovigilance and/or drug development
• Deep understanding of GCP, GVP, FDA safety regulations, ICH guidelines, and applicable global regulatory guidance
• Ability and aptitude to develop and/or expand GCP or GVP skills if needed
• Strong leadership and process improvement skills
• Excellent interpersonal communications, organization and presentation skills; experienced with FDA and other regulatory body interactions
• Strong quantitative skills, including solid familiarity with statistical and epidemiological concepts
• Able to maintain professional skills and learn new ones when necessary
• Excellent written and verbal communication in English
• Record of scientific publications is desirable
• In depth understanding of the clinical-regulatory-commercial development process and its intricacies
• Ability to work with business partners and vendors to ensure global compliance.
• Experience with global regulatory authorities in one or more major markets including USA (FDA), Europe (EMA) and Japan (MHLW)
• Experience in multiple IND and NDA or MAA filings preferred
• Business acumen and ability to provide strategic leadership to department and company

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.