Shattuck Labs, Inc. (www.shattucklabs.com) is developing breakthrough therapies for immunotherapy, which harnesses the human immune system to improve survival for patients battling cancer and inflammatory disease. Shattuck has pioneered the development of dual-sided Fc fusion proteins with the Agonist Redirected Checkpoint (ARC) platform technology. Two compounds from the platform are currently being tested in clinical trials (SL-172154 and SL-279252). In multiple published studies, ARC therapeutics have significantly outperformed traditional antibody-based therapeutics, and we believe that the dual-functionality of the ARC platform positions our product candidates with best-in-class potential as compared to traditional antibody therapeutics. Over 300 product candidates have been generated from the ARC platform and are poised for IND-enabling studies. Shattuck’s R&D and clinical operations are based in Durham, NC, and its corporate offices are in Austin, Texas.
About the Position
The translational scientist candidate will contribute to the generation of a translational research strategy and plan for molecules in or near clinical evaluation. Specifically, the role is to work cross-functionally (Research, Non-Clinical Development, Clinical, Biometrics, Regulatory) to develop and implement biomarker strategies for transitioning programs from the preclinical stage to clinical Phase 1 and Proof of Concept (PoC), and to implement the relevant biomarkers (including those that lead to patient selection) in Phase 2 and 3 studies. The candidate will support multiple clinical programs. The candidate is responsible for working collaboratively to develop hypotheses for a given clinical asset re tumor intrinsic and extrinsic mechanisms of action, predictors of sensitivity and resistance mechanisms and for designing a workflow of analyses. The role is responsible for vetting technologies and platforms offered by various vendors to interrogate these hypotheses and then ultimately selecting vendors for the analysis. The candidate should have the knowledge and experience necessary to design and guide the development of assays. The role is responsible for the acquisition and appropriate interrogation of baseline and post treatment serum, PBMC and tumor samples, development of an analysis plan, and to lead and ensure completion of analysis of immunologic and baseline characteristics and changes after treatment, towards understanding characteristics associated with antitumor activity/efficacy. The candidate will oversee external contract research organizations (CRO) activity. Furthermore, the candidate will lead the data analysis and interpretation to inform future clinical trial/correlative study design and the communication of those results. The candidate will also be expected to keep abreast of the field of immunology/immune oncology and emerging technologies to better inform our development strategy.
Summary of Key Responsibilities
· A key role will be working collaboratively with diverse functional groups within Shattuck to accomplish translational science objectives. He or she will also collaborate with Clinical Scientists, Clinical Monitors, Regulatory and External CROs in accomplishing clinical sample collection objectives and obtaining and tracking appropriate informed consent form (ICF) for research sample use. The candidate will author relevant sections pertaining to translational science/ correlative studies in regulatory documentation for regulatory submissions to governmental regulatory agencies (e.g., FDA, NIH RAC, MHRA and EMA) as well as for local regulatory bodies as needed (e.g. IRB/EC).
· Candidate will be responsible to select, oversee, coordinate and progress translational medicine studies with CROs, external analytical labs, and external clinical sites. The candidate will liaise with clinical, biometrics and regulatory to ensure alignment with strategy.
· A key role will be to maintain ongoing and productive communications on all assigned projects across stakeholders, which will include collaborators, CROs, Academic Partners, management and pharma partner. Candidate will also be expected to help author documents/presentations for internal and external audiences.
· Candidate will participate in training clinical sites on patient sample (i.e. tumor biopsies, whole blood collection, sera, etc.) acquisition requirements consistent with the company’s translational science objectives. Additional responsibilities include communicating emerging translational science data to clinical sites and investigators. Related to this responsibility will be the ongoing evaluation with respect to tissue procurement for biomarker analysis at current and prospective clinical sites for future trials. The candidate should also have a good understanding of bioinformatics with a key objective being to effectively translate the research interest of Shattuck to appropriately executable informatics requests.
· Responsible for keeping abreast of immunology/immune oncology literature for information pertaining to translational medicine and other areas related to the clinical development program, in order to inform the clinical and regulatory development teams. To this end, candidate may also draft white papers summarizing novel areas of immune/immune oncology for senior/upper management. He or she also will be expected to attend relevant conferences for the same purpose. The candidate should also have a good understanding of bioinformatics.
· Candidate will have at minimum, one direct report (FTE). Candidate will be responsible for evaluating, hiring and managing direct report(s) as needed. More specifically, duties include, but are not limited, to setting objectives (to ensure they are aligned with broader group/department), formal/informal evaluations of direct reports, and managing the professional development of their direct reports.
· PhD with at least 3 years of post-doctoral experience in immunology, oncology, molecular/cell biology or related discipline with evidence of productivity as demonstrated by publications in peer-reviewed journals and/or abstracts at conferences.
· Previous experience in biologics is required (i.e. Graduate Work, Post-Doctoral Fellowship and/or prior industry experience).
· 2+ years of experience in the biotech/pharmaceutical industry or in a CRO environment is required.
· Experience with data analysis and interpretation of data
· Experience with communicating data to internal and external stakeholders (e.g., clinical trial investigators)
· Experience working in a matrixed environment.
· Experience with clinical trial assay development and Investigational Device Exemptions (IDEs)
· Experience with companion diagnostic development
· Strategic thinking, creativity, ability to work in a highly dynamic and innovative environment
· Ability to thrive in a fast-paced and dynamic environment with frequent course corrections
· High level of self-motivation, entrepreneurial spirit, and flexibility (openness to take on additional responsibilities as needed)
· Experience interacting with investigators and clinical trial sites for successful implementation of biomarker plan
· Experience with vendor selection and oversight for biomarker sample collection
· Excellent interpersonal skills, verbal, and written communication skills
· Strong organizational skills, attention to detail and careful timeline management
· Ability to manage and progress several projects concurrently as required
· Ability to work with minimal supervision and good independent judgment.
· Strong team player that has a customer service approach and is solution oriented.
· Experience in constructing and writing regulatory filings (IND, CTA, etc.), authoring biomarker portion of clinical protocols, study procedures manuals and clinical study reports
· Basic understanding of companion diagnostic development.
· Knowledge of consenting of human subjects and human sample management requirements
· Design of Phase 1 and Phase 2a trials and/or significant prior translational medicine experience in related fields
· Significant experience in biomarker discovery and development: knowledge of research tools and platforms, assay development and validation, clinical discovery of biomarkers, analysis of biomarker data (i.e. understanding the fundamentals of high-throughput data analysis).
· Experience linking preclinical PK, PD, efficacy relationships and translation of findings to clinical trials; development of biomarkers for pharmacodynamic assessment and patient selection strategies
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.