Head of Exploratory and Regulatory Safety Sciences

About the role

The Exploratory and Regulatory Safety Sciences (ERSS) head leads a major functional area within PSA and plays a pivotal role in the development and implementation of the preclinical safety and risk management strategies for the Vertex portfolio (small molecule & VCGT) from VXc, FIH to Registration and loss of Exclusivity (LoE).

Responsibilities

• A nonclinical global regulatory expert in nonclinical toxicology and regulatory guidelines
• Accountable for providing nonclinical regulatory strategy leadership, oversight, and advice across the organization to achieve Vertex’s goals
• Advances regulatory acceptance of innovative scientific approaches and insight
• Deep understanding of drug development approaches
• Promotes regulatory packages to accelerate portfolio deliverables
• Subject matter expert in nonclinical and late-stage development and registration for small molecules, biologics, cell therapies and other complex novel modalities
• Matrix leader across the preclinical safety assessment (PSA) organization with in-depth understanding of preclinical sciences and its relevance to drug discovery and clinical development
• Performs all regulatory responsibilities in compliance with applicable regulatory standards
• Contributes to and aligns with Issues Management plans for the portfolio
• Participates in regulatory submission document preparation, poster presentations and scientific publications, including addressing queries from global health authorities
• Addresses and resolves toxicological issues arising in drug development programs and adequately assess the relevance of these findings to human safety
• Toxicology Disease Area Lead (TDAL) for one or more disease areas
• A member of the PSA leadership team and Extended Team member of the PCS-LTE
• Forges strong partnerships (within discipline, other nonclinical and clinical lines) and build credibility to shape senior leader thinking on safety issues and collaborate internally and externally to deliver on functional/departmental/Vertex goals
• Responsible for the development of the next generation of PSA ERSS leaders
• Accountable for ERSS resource allocation and external influencing
• Led Vertex engagement in the external environment such as consortia (IQ etc.)

Requirements

• Ph. D., and/or DVM or equivalent
• 15 years of experience of preclinical safety research and development in the pharma/biotech industry
• Expertise in preclinical development for small molecules and biologic/biotherapeutics and other complex or novel modalities
• Deep understanding of preclinical sciences and its relevance to drug discovery and clinical development
• Strong understanding of FDA, EMA, and ICH regulatory guidance in drug development and in depth understanding of GLP guidelines internationally
• Highly refined writing skills that complement advanced intellectual contributions, and superior persuasiveness, and/or charisma, for convincing audiences of scientific vision
• Strong analytical and problem-solving skills; expected to lead troubleshooting in all areas of preclinical development
• Documented success in partnering/influencing other senior leaders to ensure alignment of issue resolution strategies across enterprises
• Makes good scientific and regulatory decisions based on a mixture of analysis, wisdom, experience, and judgment
• Can make high quality decisions in an ambiguous environment, e. g. without access to all the data
• A problem solver, pragmatist, and an excellent communicator/influencer
• Highly refined writing skills that complement advanced intellectual contributions, and superior persuasiveness, and/or charisma, for convincing audiences of scientific vision
• Experience leading within a highly matrixed organization
• Highest work ethic and professional integrity; proactive, dynamic and “hands on”

Qualifications

• Required Education & Experience

Required Education & Experience:

• Ph. D., and/or DVM or equivalent
• 15 years of experience of preclinical safety research and development in the pharma/biotech industry
• Expertise in preclinical development for small molecules and biologic/biotherapeutics and other complex or novel modalities
• Deep understanding of preclinical sciences and its relevance to drug discovery and clinical development
• Strong understanding of FDA, EMA, and ICH regulatory guidance in drug development and in depth understanding of GLP guidelines internationally
• Highly refined writing skills that complement advanced intellectual contributions, and superior persuasiveness, and/or charisma, for convincing audiences of scientific vision
• Strong analytical and problem-solving skills; expected to lead troubleshooting in all areas of preclinical development
• Documented success in partnering/influencing other senior leaders to ensure alignment of issue resolution strategies across enterprises
• Makes good scientific and regulatory decisions based on a mixture of analysis, wisdom, experience, and judgment
• Can make high quality decisions in an ambiguous environment, e. g. without access to all the data
• A problem solver, pragmatist, and an excellent communicator/influencer
• Highly refined writing skills that complement advanced intellectual contributions, and superior persuasiveness, and/or charisma, for convincing audiences of scientific vision
• Experience leading within a highly matrixed organization
• Highest work ethic and professional integrity; proactive, dynamic and “hands on”

Skills

• Nonclinical global regulatory expert in nonclinical toxicology and regulatory guidelines
• Subject matter expert in nonclinical and late-stage development and registration for small molecules, biologics, cell therapies and other complex novel modalities
• Matrix leader across the preclinical safety assessment (PSA) organization with in-depth understanding of preclinical sciences and its relevance to drug discovery and clinical development
• Performs all regulatory responsibilities in compliance with applicable regulatory standards
• Contributes to and aligns with Issues Management plans for the portfolio
• Participates in regulatory submission document preparation, poster presentations and scientific publications, including addressing queries from global health authorities
• Addresses and resolves toxicological issues arising in drug development programs and adequately assess the relevance of these findings to human safety
• Toxicology Disease Area Lead (TDAL) for one or more disease areas
• A member of the PSA leadership team and Extended Team member of the PCS-LTE
• Forges strong partnerships (within discipline, other nonclinical and clinical lines) and build credibility to shape senior leader thinking on safety issues and collaborate internally and externally to deliver on functional/departmental/Vertex goals
• Responsible for the development of the next generation of PSA ERSS leaders
• Accountable for ERSS resource allocation and external influencing
• Led Vertex engagement in the external environment such as consortia (IQ etc.)

Benefits

• Annual bonus
• Annual equity awards

Pay

$280,000 - $420,000

Schedule

Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status In this Hybrid-Eligible role, you can choose to be designated as: Hybrid: work remotely up to two days per week; or select On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.