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Senior Director, Toxicology - CART Cell Therapies

Company: Sana Biotechnology
Location: Cambridge
Posted on: May 12, 2022

Job Description:

About the role Sana Biotechnology is growing, and we are hiring new team members who believe in the potential of engineered cells as medicines, who want to challenge status quo, and who lead with the desire to work on novel ideas. As a Senior Director/Executive Director, Toxicology - CART Cell Therapies, you will report to VP Toxicology, Pathology, & Biodistribution to oversee the non-clinical development and advancement of our cell therapy portfolio into the clinic and bring strategic input to Senior Management to align and advance corporate goals and milestones. The qualified candidate is a highly motivated, interactive, and creative individual that has demonstrated expertise in drug development to work across a highly matrixed environment to advance translational efforts. This role is integral to driving discovery research into the clinic, including exploratory, pilot, and pivotal toxicology studies and health authority interactions. The candidate must possess a demonstrated ability to apply critical thinking to solve complex problems to craft customized preclinical strategies for novel therapeutics. This person is responsible for the overall strategy and conduct of the studies supporting a Project Team and is thus an expert on study process and specialist needs for cell and or gene therapy products. The candidate will be expected to work collaboratively within Development Sciences and to liaise closely with the Project teams to develop safety strategies for advancement to the clinic. What you'll do

  • Lead the safety strategy for Project and Core Teams by solving complex problems to craft customized solutions for multiple novel CART-based therapeutics
  • Work collaboratively with Research (internal and external partners), Pharmacology, Pathology, CMC, Bioanalytical scientists, Translational and Clinical Sciences to progress therapeutics through the pipeline from discovery to launch
  • Provide internal expertise to understand the mechanisms of toxicity observed non-clinically and/or clinically to drive mitigation and/or back-up strategies to minimize potential harm to patients
  • Present data and interpretations in written and oral form to Project Teams, Research & Development Committee or Senior Executive Team (as needed)
  • Liaise with Associate Director of Non-clinical Operations and internal Sponsor Representative/Study Monitor to build and maintain effective CRO relationships for the execution of studies including: contracting, management/oversight and monitoring of studies at CRO's
  • Write regulatory summaries for safety pharmacology, biodistribution, and toxicology data sets for submissions in the US and ex-US (eg. IND, CTA, BLA, briefing books, Investigator Brochures etc)
  • Working knowledge of code of federal regulations (eg. CFR 21 Part 11 and Part 58 etc) and regulatory guidance's (eg. FDA, EMA, ICH etc) as it pertains to the strategic planning and conduct of safety packages to support first-in-human (FIH) testing
  • Build collaborative networks both internal and external to the company to ensure rapid communication and cross-functional evaluations and investigation
  • Represent SANA Bio in the external scientific environment
  • Demonstrate ability to engage and effectively influence team members across multidisciplinary teams while prioritizing multiple projects and meeting deadlines
  • Drive curiosity, scientific rigor and excellent problem-solving skills across a fast-paced performance driven environment What we're looking for
    • PhD or DVM and 10+ years of experience in immuno-oncology in a pharmaceutical/biotech setting
    • Demonstrated subject matter expert in development of immuno-oncology or CART-cell therapies with demonstrated ability to work with abstract ideas or situations across functional areas of the business
    • Prior role in multidisciplinary projects and teams with demonstrated ability to successfully integrate cross-functional information to support the functional area and deliver on the business strategy and company goals
    • Demonstrated ability in developing and implementing safety or pharmacology strategies for teams including species selection, biodistribution, target organ identification, and selection and justification of maximum tolerated dose or NOAEL across different therapeutic areas or modalities, e.g. biologics, cell or gene therapies
    • Strong executive communication skills, awareness of how to negotiate, and conduct crucial conversations to solve complex problems
    • Strong scientific writing skills to prepare and review non-clinical sections (eCTD Modules 2.4 and 2.6) for IND or CTA submission, preparation of briefing books (Interact or Pre-IND), Investigator Brochures, BLA etc
    • Strong collaboration and relationship building and decision-making skills
    • Working knowledge of regulatory needs for conduct of both non-GLP and GLP studies
    • Familiarity with presenting strategy to teams or management, aligning and achieving buy-in for strategic approach including risk-based approach What will separate you from the crowd
      • PhD in pathology, comparative biology, molecular pathology, immunology, virology, or a related field
      • Familiarity with developing/advancing safety or preclinical strategies for cell and gene therapies to enable project teams
      • Demonstrated skills in critical thinking, problem solving, and mechanistic investigation evidenced by scientific publications or presentations a plus What you should know
        • Some travel may be expected to visit with Sana colleagues at other sites, external collaborators, contract laboratories, or for regulatory meetings
        • Working safely in person on a predictable and regular in-person basis is an essential job function for this position, and the Company requires that all individuals working in-person be fully vaccinated against COVID-19, including receipt of a vaccine booster shot if recommended by the CDC How we work together
          • Lead from every seat - we seek to understand, act with honesty, and engage in the crucial conversations
          • Thrive as a team - we hire amazing people, are intensely curious, and cultivate inclusion and personal connectivity
          • Make it happen - we value vigorous debate, alignment around our decisions, and resilient execution Get to know us At Sana, we believe that a diverse workforce strengthens us as a company and helps us to achieve our mission to meaningfully change the outcome of many human diseases. This belief is a pillar of our business and is critical to our success. Our goal is that Sana is the place for talented people to bring their authentic selves to work, to have a great career and to deeply, positively impact patients. Core to our values, we believe there is nothing more important than the health and wellness of you and your family. For benefit eligible employees, we cover 100% of the cost for employee health coverage and offer generous time-off, parental leave, short- and long-term disability, employer paid basic life insurance, additional voluntary life insurance protection, financial wellness programs including financial planning resources, a 401(k) Plan with an immediately vested employer match, Tuition Reimbursement and Student Loan Repayment, Employee Stock Purchase Plan, commuter subsidy and a variety of wellness offerings to support each person individually. We are committed to providing a workplace free of discrimination and harassment based on race, color, religion, age, gender, national origin, ancestry, physical or mental or sensory disability (including the use of a trained guide dog or service animal by a person with a disability), genetic information, actual or perceived HIV or Hepatitis C infection, medical condition (cancer or a record or history of cancer and genetic characteristics), marital status, sexual orientation, sexual preference, pregnancy (including childbirth and related medical conditions), disability, veteran status, political ideology, social class (including caste/caste identity), taking or requesting statutorily protected leave, status as a victim of domestic violence, sexual assault or stalking, or any other basis prohibited by applicable law. To perform this job successfully, you must be able to perform each job responsibility satisfactorily. The job description listed above is representative of the knowledge, skills, and/or abilities required for this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions described above.

Keywords: Sana Biotechnology, Cambridge , Senior Director, Toxicology - CART Cell Therapies, Executive , Cambridge, Massachusetts

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