Gene Therapy Toxicologist

Cambridge, Massachusetts
November 16 2020
Position Type
Full Time
Organization Type
Role Summary

The Gene Therapy (GTx) Toxicologist (TOX) will lead issues management teams for topics related to GTx safety and advise key stakeholders/decision makers on scientific and regulatory strategies and direction. The candidate will be expected to have and/or build wider recognition internally and externally over the long term and will use their knowledge as a credible scientific and strategic advisor to positively impact Pfizer project progression in delivering acceptable, expedited regulatory packages for our GTx portfolio. The GTx TOX will also serve as a project team representative on internal GTx teams and in-licensing reviews.

Role Responsibilities
  • Primary role: Remain current on key topics on the safety of gene therapy as they apply to risk assessment and meeting regulations for all GTx modalities with a focus on AAV-based gene therapies. One key scientific area presently for the GTx TOX is to lead building Pfizer's framework for the proper models and data for the risk assessment of insertional mutagenesis, starting with AAV, but also editing approaches
  • Secondary role: Direct participation in/support of in-licensing/acquisition due diligence evaluations and serving as a Drug Safety Research & Development (DSRD) project team representative on GTx project teams. These will be important adjuncts that will strengthen the relevance and application of the primary scientific aspects of the role. Maintain or build external relationships with other GTx KOLs to stay abreast of relevant changes in the scientific and regulatory landscape. These KOLs may serve as DSRD consultants as issues arise
  • Is a leading and central contributor in forming DSRD-wide GTx strategy that will enable project team plans across WRDM
  • Collaborate with all DSRD lines, Rare Disease RU and other Pfizer lines to enable GTx strategies, development plans, regulatory correspondence and filings
  • Participates in GTx toxicology study design discussions, issues management teams and external influence consortia efforts
  • Mentor/assist junior colleagues across DSRD lines to build their working knowledge of GTx drug development
  • Contributes to organizational and regulatory acceptance of innovative scientific approaches, biomarker strategies and regulatory packages to accelerate portfolio deliverables in collaboration with the relevant lines.
  • Uses their summed expertise, contacts and capability to streamline and expedite Pfizer study designs and regulatory packages and shape the evolution of international regulations as are brought forward
  • Conduct and publish safety related work to advance the scientific and regulatory frameworks of gene therapy risk assessment.
  • Lead and participate in industry consortia and scientific association efforts related to GTx safety

Basic Qualifications
  • Ph.D., D.V.M., or equivalent experience
  • ~10 years Pharmaceutical experience required in investigative toxicology combined with drug development experience assembling toxicology programs and filings for IND/CTA
  • Expertise in GTx discovery, development and risk assessment desired, but the ability to rapidly learn the GTx arena if other key attributes of the role are satisfied - ie - strong molecular biology and prior risk assessment/drug development experience on Non-GTx modalities
  • Deep knowledge of molecular biology, NGS and bioinformatics interpretations
  • Demonstrated ability to work collaboratively across a broad network of internal and external stakeholders
  • Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact

Preferred Qualifications
  • Above plus direct GTx experience in teams and risk assessment

Other Job Details:
  • Eligible for Employee Referral Bonus
  • Eligible for Relocation Package


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Research and Development