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J&J Family of Companies Director, Cell/Molecular Genetic Toxicology & Risk Assessment in Spring House, Pennsylvania

Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for a Scientific Director of Cell/Molecular Genetic Toxicology located in the US or Beerse, Belgium. This role reports into Global Head of Genetic Toxicology, a department in the Nonclinical Safety (NCS) organization within Janssen Research & Development.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com (file:///C:/Users/jamie%20yacco/AppData/Local/Microsoft/Windows/Temporary%20Internet%20Files/Content.Outlook/JHNHJA6O/www.janssen.com) and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies. Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.

The Scientific Director role for molecular innovations and risk management in genetic toxicology provides critical leadership and expert support for the development and risk assessment of new cellular and gene therapies in development. This position has a leadership role in genetic toxicology, provides direct expertise to project teams and develops partnership with Contract Research Organizations (CROs) and academic research institutes to assess the potential for insertional mutagenesis of viral vectors, karyotype instability of iPS cells and other in vitro cell systems and in vivo animal models used for assessing gene therapies including the potential for off-target DNA damage/recombination of CRISPR gene editing and other new modalities/technologies used to create gene edits. This role will also be expected to support due diligence teams and Nonclinical Safety (NCS) Teams to review and address concerns on genotoxicity findings and mitigation strategies for small/large molecules, and cell or gene therapies.

As part of the leadership team in the genetic toxicology group, this candidate will provide scientific leadership and expertise as part of a cross functional Genetic Toxicology Review Committee and provide clear responses to address queries from Health Authorities. This role will also identify, assess, and develop partnerships with key consultants and innovative testing laboratories to support development of an integrated genotoxicity safety risk assessment.

The role requires experience conducting cellular/molecular testing for off-target DNA damage and/or insertional mutagenesis, as well as an understanding of genetic toxicology and the tests needed to assess genotoxic risk of new molecular small and large molecules in pharmaceutical development. The role also requires a solid track record of problem-solving, troubleshooting, and application of new technologies, predictive tests and relevant in silico computational systems. To be successful, the role requires experience supporting multiple development programs simultaneously, and a strong knowledge of genetic toxicology testing and regulatory guidances for cell and gene therapies.

In general, the role is required to comply with organizational and company standard operating procedures, including training and project time accounting. Must takes responsibility for the quality and timeliness of project deliverables and follows best practices for data integrity.

  • Demonstrates thorough knowledge of pharmaceutical research and development strategies and execution. Is an established leader and recognized external expert in technologies associated with cell and gene therapies with a keen understanding of data interpretation and relevant risks of potential adverse findings.

  • Is well experienced in providing input to cross-functional teams in terms of developing genetic toxicology risk mitigation strategies for API and impurities, and optimizing genotoxicity study designs appropriate to study or modality aligned objectives.

  • Demonstrates a strong sense of urgency and commitment to prioritize most urgent requests, providing timely stakeholder and health authority feedback to meet timelines.

  • Ability to supervise postdoctoral scientists/interns/co-ops as required and provides input into hiring decisions and ongoing evaluation of talent.

  • Serves as a role model, and mentor to technical staff and other scientists in techniques, processes, and responsibilities needed for assessing genotoxic risk of cell/gene therapy based modalities by sharing knowledge within and across functions.

  • Identifies and leads process improvements or innovative development initiatives both internally and externally as needed to identify and mitigate genotoxicity risks, particularly for cell and gene therapies. Develops strong collaborations and partnerships with the Predictive Investigative & Translational Toxicology group for issue resolution of potential genotoxic risks.

  • Has a solid understanding of potential adverse outcome pathways at the molecular level and can translate the effects to potential outcomes in vivo in animal models and to diverse patient populations with respect to age, gender and relevant polymorphisms. In partnership with Translational Medicine, Pathology, Developmental and Reproductive Toxicology and other subject matter experts in cellular and molecular modalities, provide an assessment of potential long-term risks to patients including carcinogenicity and reproductive/ developmental adverse outcomes, and assess potential causal associations of any secondary malignancies seen in patients with the cell/molecular therapeutic.

  • Builds and manages cross-functional partnerships with internal and external partners including discovery pharmacology, drug metabolism and pharmacokinetics, Janssen Biologics, and external technology and system providers (CROs, academic institutes, etc), and consultants to achieve results for project focused needs.

  • Demonstrates excellent written, oral, interpersonal communication and organizational skills.

Qualifications

  • Ph.D. in Molecular Genetics, Molecular Genetic Toxicology or related fields, with minimum of 10 years of relevant postdoctoral and/or pharmaceutics experience

  • Strong written, oral, and interpersonal communication skills required with strong publication record in molecular genetics.

  • Ability to work independently but requires excellent networking and partnership skills to develop strong collaborations with staff across the organization and external experts and key opinion leaders.

    This role will require willingness to work across time zones and primarily work on a US east coast schedule regardless of work location and will require some travel.

Primary Location

United States-Pennsylvania-Spring House-Welsh & McKean Roads

Other Locations

Europe/Middle East/Africa-Belgium-Antwerp-Beerse, United States-California-South San Francisco, Europe/Middle East/Africa-United Kingdom-England-High Wycombe, United States-California-San Diego, North America-United States-New Jersey-Raritan

Organization

Janssen Research & Development, LLC (6084)

Job Function

R&D

Requisition ID

2105921735W

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