Sr/Executive Director of Translational Medicine
Company: Shattuck Labs, Inc.
Location: Durham
Posted on: August 6, 2022
Job Description:
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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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