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Senior Director of Preclinical Research

Q32 Bio is advancing an innovative platform and integrated portfolio of immunomodulatory therapies. With our strategy of protein-based molecules we aim to deliver life-changing treatments for patients with a variety of diseases for whom inadequate options exist.

Our dynamic, industry-experienced team is growing.  The Research organization is seeking a highly motivated, independent, Senior Director of Preclinical Research with a strong background in immunology/inflammation who desires to be part of an energetic, fast-paced and collaborative team. The immediate focus is to move lead molecules through optimization, validation, preclinical development and IND-filing. The successful candidate will have direct oversight of the preclinical research strategy and activities supporting the advancement of programs from early research into early stages of clinical development.  This position will report to the CSO and President of Research.

 

RESPONSIBILITIES:

  • Provide scientific leadership and manage a team of scientists to execute on the goals of the company, including prioritizing research activities that enable project decision-making and progression
  • Contribute to drug candidate selection and portfolio prioritization to recommend the best course of preclinical development in coordination cross departmental teams
  • Lead the design of preclinical protocols, data interpretation, and summarize findings
  • Contribute to company strategy as an active member of the senior management team
  • Communicate research plans, activities and progress on goals to Board of Directors and Scientific Advisory Board
  • Develop research packages to support IND filings
  • Identify and manage high quality Contract Research Organizations (CROs) to perform critical in vitro and in vivo activities; this includes direct involvement in design, development and transfer of protocols and assays to CROs as well as overseeing validation activities, data analysis and finalization of reports
  • Interface with all functional groups within Q32 Bio: discovery, translational science, CMC and clinical development and operations
  • Establish and maintain collaborations with key academic labs to expand and support our research strategy
  • Provide research input to support our translational biomarker activities and preclinical-toxicology PK/PD readouts
  • Develop a research strategy and timelines that are integrated into overall Q32 program goals
  • Oversee outsourced studies, critically review study results and report and approve study reports prior to finalization by the test facility
  • Interact with Regulatory personnel to author relevant sections of regulatory submission documents including INDs, NDA/BLA, MAAs as well as preclinical sections of Investigators Brochures, CTA applications, IMPDs, etc.
  • Consistently review relevant literature to strengthen our position in the immunology/inflammation research space and to advance Q32 Bio programs
  • Assist with maintaining key intellectual property and develop and execute plans to strengthen IP positions
  • Prepare and submit abstracts and support development of manuscripts for publication

 

REQUIREMENTS/QUALIFICATIONS:

  • PhD in a scientific discipline preferably immunology, inflammation, cell biology or related field and 15+ years related laboratory experience in a biotech/pharma environment
  • Track record of publications and patents
  • Demonstrated expertise designing, executing and interpreting in vivo preclinical studies to develop an IND package
  • Experience with identification and management of Contract Research Organizations, including assay transfer and validation
  • Previous management experience of a diverse scientific team
  • Experience across a wide range of in vivo models, analytical tools, and cellular and biochemical assays
  • Effective communicator and leader with excellent organization skills and ability to articulate short- and long-term strategic goals
  • Strong interpersonal, organizational and problem-solving skills, and the ability to work effectively and collaboratively in a fluid, fast-paced research environment

 

CONTACT: Please send Resume and Cover letter to info@q32bio.com.