Pfizer is seeking an individual to join our team in an exciting new role supporting our innovative gene therapy portfolio. The qualified candidate will be a member of Environmental Sciences, operating within the Pharmacokinetics, Dynamics and Metabolism (PDM) line, responsible for developing environmental risk assessments for all gene therapy clinical trials and regulatory submissions worldwide in support of the Pfizer portfolio. The individual will interface internally with several partner organizations involved in various clinical, regulatory, policy and scientific aspects of the gene therapy portfolio as well as externally with regulatory authorities, contract research organizations (CROs) and subject matter experts (SMEs) from academia, government and industry.
+ Develop regulatory strategies and author environmental risk assessments (ERAs) in support of global clinical trial applications (CTAs) and drug approval (MAA) registrations for all gene therapies (GTx). Manage and write responses to all GTx ERA regulatory agency queries associated with CTAs and MAAs .
+ Coordinate and manage delivery of GTx ERAs to meet gene therapy CTA and MAA regulatory timelines by working in partnership with Pfizer’s CTA Liaison Group, Asset Teams, Pfizer Country Offices (PCO) and other stakeholders.
+ Establish an efficient and effective GTx process for delivery of CTA and MAA ERAs in partnership with CTA Liaison Group and other stakeholders.
+ Coordinate and utilize viral vector shedding and biodistribution data generated by partners to aid in GMO and regulatory filings.
+ Represent Environmental Sciences on both internal and external teams. Provide expert guidance on environmental issues related to gene therapies, GTx ERAs, and regulatory compliance to Pfizer internal teams. Actively participate in trade association(s) and external organizations/teams involved in issues concerning the environmental impact of gene therapies and policy shaping the future landscape in this space.
+ Take the leadership role in 1) developing and communicating scientific strategies to identify and mitigate environmental risks associated with the post-consumer fate of gene therapy products and 2) training/educating colleagues on preparation of GTx ERA documents.
+ Employ pertinent aspects of chemistry, biology, public health, industrial hygiene and toxicology to develop human and environmental exposure assessments to include propensity for viral shedding and disease transmission as well as the human health impact from exposure to gene therapy drug products.
+ Leverage knowledge of SMEs and utilize laboratory data, literature and other relevant sources to define and effectively communicate primary, secondary, and tertiary impacts of gene therapies on the human population and the environment.
+ Accountable for compliance with national and/or regional guidelines and applicable regulatory requirements and ensuring overall quality and integrity of ERAs and related documents are fit for regulatory purpose.
+ Ensure drug development programs use contemporary regulatory-required protocols, and robust data interpretation while considering the dynamic regulatory environment throughout various markets worldwide.
+ Establish and maintain professional contacts, effectively communicate technical advice essential to the assessment process. Interact with and influence regulatory authorities and/or external scientific committees.
+ Bachelors Degree in virology, environmental toxicology, toxicology, public health or environmental sciences
+ 10+ years of environmental risk assessment experience, 5+ years of GTx environmental risk assessment experience highly desirable
+ Professional knowledge of the principles of human and environmental toxicology, viral transmission and hygiene, occupational safety, and environmental science
+ Ability to recognize and evaluate human health impacts of exposure to environmental agents (chemicals, microbial agents, specifically gene therapy drug products).
+ Interpret and effectively communicate (oral/written) summaries of experimental/clinical data.
+ Ability to interpret and apply regulatory guidelines and policies. Compare market equivalent products testing and apply strategy to internal projects.
+ Excellent communication skills (oral/written), as required to effectively interact with regulators and diverse group of SMEs in a team environment.
+ Demonstrable experience collaborating within a complex matrix environment.
+ Masters or PhD degree in virology, environmental toxicology, toxicology, public health or environmental sciences with approximately 2-3 years of GTx environmental risk assessment experience, 5+ years of environmental risk assessment experience highly desirable
+ Demonstrated track record in successful multinational GMO ERA submissions and approvals for CTAs and/or MAAs.
+ Familiar with worldwide ERA regulatory requirements.
+ Prior work with cell and gene therapy products in clinical trials.
+ Knowledge of drug development process and manufacturing, supply chain and distribution.
**Other Job Details**
+ Last Date to Apply for Job: September 25, 2020
+ Eligible for Employee Referral Bonus
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Research and Development