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Sr/Executive Director of Translational Medicine

Company: Shattuck Labs, Inc.
Location: Durham
Posted on: August 6, 2022

Job Description:

This website is AudioEye enabled and is being optimized for accessibility. To open the AudioEye Toolbar, press shift + =. The toolbar contains the followingThe AudioEye Help Desk to report accessibility and usability related issues.The AudioEye Certification Statement to explain the ongoing web accessibility and usability enhancements for this website.The Player tool to listen to this site read aloud. The Player is not intended as a substitute for your screen reader. If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process. Sr/Executive Director of Translational Medicine 30+ days ago Requisition ID: 1057 Summary of Key Responsibilities

  • Work collaboratively with diverse functional groups within Shattuck to facilitate appropriate incorporation of translational medicine strategies for molecules in development. Select biomarkers for clinical studies based on the best available science and technologies. -
  • Lead the overall design and execution of biomarker assays including immunophenotyping, cytokine, immunohistochemical, and receptor occupancy assays. Vet technologies and platforms offered by various vendors to interrogate defined hypotheses. Select vendors and oversee assay development. Ensure clinical assays developed and validated are fit for purpose. -
  • Appropriately acquire and interrogate baseline, on-treatment, and post-progression serum, PBMC and tumor samples. Provide guidance to the biomarker sample manager on the necessary requirements for sample acquisition. Participate in training clinical sites on patient sample acquisition requirements. Lead the team to achieve timely completion of sample analysis. -
  • Work with the clinical, pharmacometric, and biometrics teams to author a study specific analysis plan and detail the workflow of analyses. Lead the analysis and interpretation of biomarker data from Shattuck's clinical trials. Work with the pharmacometrics to drive the analysis and interpretation of PK/PD data from Shattuck's clinical trials. -
  • Synthesize clinical and pre-clinical learnings for each compound and target and recommend both bench-to-bedside and bedside-to-bench follow up studies which could aid in better interpreting the mechanisms of action of Shattuck's compounds. -
  • Author relevant sections pertaining to translational research in clinical trial documents including protocols and informed consent forms. Contribute to and ensure the quality of Translational Medicine clinical study reports, data reviews and interpretations, presentations, scientific publications and recommendations to study teams and management. Communicate emerging translational science data to investigators. -
  • Remain abreast of new developments in immune-oncology and emerging technologies as they pertain to the translational medicine objectives. This will be accomplished via attendance of scientific conferences, KOL interactions and frequent review of the literature. Draft white papers summarizing novel areas of immune/immune oncology for senior management as needed. -
  • Manage the yearly translational medicine budget in collaboration with the biomarker sample manager. -
  • Evaluate, hire, and manage direct report(s) as needed. Management responsibilities include setting near term and yearly objectives (to ensure they are aligned with broader group/department), training and overseeing performance, formal/informal evaluations and managing their professional development. Required Qualifications -
    • MD/PhD, MD or PhD with at least 8 years of experience in immuno-oncology research with evidence of productivity as demonstrated by publications in peer-reviewed journals and/or abstracts at conferences. -
    • 5+ years of translational medicine experience in the biotech/pharmaceutical industry. -
    • Previous experience in biologics (i.e., Graduate Work, Post-Doctoral Fellowship and/or prior industry experience) - Required Skills -
      • Have an in-depth knowledge of oncology disease area biology and translational science, with expertise in immuno-oncology -
      • Have a genuine interest in understanding the science and supporting the clinical development of the Shattuck pipeline. -
      • Be a team player who is willing to work collaboratively and learn from a multifunctional team. -
      • Strategic thinking, creativity, and ability to work in a highly dynamic and innovative environment -
      • High level of self-motivation, entrepreneurial spirit, and flexibility with an openness to take on additional responsibilities as needed -
      • Significant experience in biomarker discovery, clinical drug development and data analysis and interpretation. Knowledge of research tools and platforms, assay development and validation, analysis of biomarker data including an understanding of bioinformatics -
      • Experience translating preclinical PK, PD, safety, and efficacy data to clinical trials; development of biomarkers for pharmacodynamic assessment and for patient selection strategies -
      • Experience interacting with investigators and clinical trial sites for successful implementation of biomarker plan and communicating data to internal and external stakeholders -
      • Experience with vendor selection and oversight -
      • Have outstanding leadership and organizational skills and operational capabilities. Ability to handle complex issues and multi-task current project demands; must be able to prioritize and deliver effectively and on-time with minimal supervision. -
      • Have excellent interpersonal and communication skills. Scientific research and writing skills required; ability to critically evaluate the published medical and scientific literature; write comprehensive, accurate and scientifically balanced documents. -
      • Experience in constructing and writing regulatory filings (IND, CTA, etc.), authoring biomarker portion of clinical protocols, study procedures manuals and clinical study reports -
      • Working knowledge of requirements for clinical trial assays used for patient selection and Investigational Device Exemptions (IDEs). Basic understanding of companion diagnostic development. -
      • Knowledge of consenting of human subjects and human sample management requirements as per GCP and GLP -
      • Have enthusiasm, scientific curiosity, high emotional intelligence, sound temperament and professional attitude. - Note to External Recruiters: -Our Human Resources department manages all open positions and candidate recruitment. We kindly ask that recruiters not contact employees or hiring managers directly to present candidates or solicit business. Please note that we will consider failure to comply with this request when determining whether to enter into a professional relationship with a recruiting agency. Please also note that submission of unsolicited resumes does not create any obligations for Shattuck Labs, implied or otherwise. - Note to Job Applicants: New employees will be required to be in compliance with Shattuck's EEOC-compliant COVID-19 vaccination policy.

Keywords: Shattuck Labs, Inc., Durham , Sr/Executive Director of Translational Medicine, Healthcare , Durham, North Carolina

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