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Associate Director/Director, Pre-Clinical Safety Assessment

Company: THIRD ROCK VENTURES, LLC
Location: Cambridge
Posted on: September 19, 2022

Job Description:

Associate Director/Director, Pre-Clinical Safety Assessment at Tango Therapeutics Tango Therapeutics is a biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer. Using an approach that starts and ends with patients, Tango leverages the genetic principle of synthetic lethality to discover and develop therapies that take aim at critical targets in cancer.This includes expanding the universe of precision oncology targets into novel areas such as tumor suppressor gene loss and their contribution to the ability of cancer cells to evade immune cell killing. Tango's labs and offices are currently located in Cambridge. We will be relocating to a new space at 201 Brookline Avenue, in the Fenway area of Boston, in Q3 2022. Job Summary: Reporting to the Head of Pharmaceutical Sciences, this individual will provide the leadership, functional expertise, and sense of urgency to develop and execute non-clinical drug development strategies.This position has functional responsibilities for Preclinical Safety Assessment. Job Responsibilities:

  • Worksclosely with Discovery Chemistry,Research Pharmacology,Drug Metabolism & Pharmacokinetics, Clinical Pharmacology, Clinical Development and Regulatory Affairsto implement discoveryand developmenttoxicology strategiesthatenable the progression of optimized drug candidates.
  • Responsible for pre-clinical safety assessments:safety pharmacology, genetic toxicology, general toxicology, reproductive toxicology, and toxicokinetics.
  • Lead the development of early hypothesis-driven investigation into mechanisms of toxicity.
  • Proactively manage potential safety liabilities.
  • Provide strategic and operational leadership for nonclinical development programs.
  • Plan and execute nonclinical safety studies (investigative, non-GLP and GLP).
  • Provide strategic guidance to project teams and senior management.
  • Develop study protocols: review, revise, and issue regulatory reports.
  • Prepare regulatory documents including briefing books, investigational new drug applications (INDs), Investigator Brochures (IBs), New Drug Applications (NDAs), and Marketing Authorization Applications (MAAs).
  • May act as thecompanytoxicology representative with health authorities.
  • Work with program leadership to meet timelines and objectives.
  • Responsible for developing and maintaining CRO and consultant relationships.
  • Perform due diligence reviews on potential in-licensing candidates.
  • Develop target safety reviews with risk mitigation plans for early drug discovery teams.
  • Prepare relevant Standard Operating Procedures (SOPs) pertaining to pre-clinical safety. Skills & Qualifications:
    • DVM or Ph.D. in an area relevant to pre-clinical safety assessment is required
    • Diplomat of the American Board of Toxicology (DABT) or American College of Veterinary Pathology (ACVP) board certification is highly desired
    • Minimum of 8 years of progressive post-graduate work experience is required
    • To be considered for Director level you must have a
    • Experience in biotechnology or pharmaceutical industry is preferred
    • At least 2 years of experience in the oncology therapeutic area is required
    • Previous experience with successful regulatory submissions (INDs and/or NDAs) as lead toxicologist is highly desired
    • Experience managing CRO relationships is a plus
    • In-depth understanding of small molecule drug discovery and development is preferred
    • Sound theoretical and experimental background in toxicology and pharmacology
    • Current knowledge of Good Laboratory Practices (GLP)
    • Working knowledge of US and international regulatory requirements for the design and conduct of nonclinical safety studies
    • Experience interacting with the FDA and ex-US regulatory authorities is preferred
    • Ability to influence positively including in situations without direct authority
    • Excellent verbal and written communication and skills
    • Ability to work independently and collaboratively, in a matrix team environment consisting of internal and external team members
    • Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
    • Excellent planning, organization and time management skills including the ability to support, prioritize, and multi-task We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Keywords: THIRD ROCK VENTURES, LLC, Cambridge , Associate Director/Director, Pre-Clinical Safety Assessment, Executive , Cambridge, Massachusetts

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