Shattuck Labs, Inc. (www.shattucklabs.com) is a clinical-stage biotechnology company pioneering the development of bi-functional fusion proteins as a new class of biologic medicine for the treatment of patients with cancer and autoimmune disease. Compounds derived from Shattuck’s proprietary Agonist Redirected Checkpoint, ARC®, platform simultaneously inhibit checkpoint molecules and activate costimulatory molecules within a single therapeutic. Shattuck has created over 300 unique bi-functional fusion protein therapeutic candidates. The company’s lead wholly owned program, SL-172154 (SIRPα-Fc-CD40L), which is designed to block the CD47 immune checkpoint and simultaneously agonize the CD40 pathway, is being evaluated in a Phase 1 trial. A second compound, SL-279252 (PD1-Fc-OX40L), is being evaluated in a Phase 1 trial in collaboration with Takeda Pharmaceuticals. Additionally, the company is advancing a proprietary Gamma Delta T Cell Engager, GADLEN™, platform, which is designed to bridge gamma delta T cells to tumor antigens for the treatment of patients with cancer. Shattuck has offices in both Austin, Texas and Durham, North Carolina.
About the Position
The Director of Translational Medicine will design and implement a translational research strategy for each molecule in or nearing clinical evaluation. The Director will support multiple clinical programs. Specifically, the role is to work cross-functionally and collaboratively (with Preclinical Research and Development, Non-Clinical Development, Clinical, Biometrics, and Regulatory) to develop and operationalize biomarker strategies for programs transitioning from the preclinical stage to clinical Phase 1 and Proof of Concept (PoC). Translational research plans for early phase compounds will focus on developing hypotheses for a given clinical asset re tumor intrinsic and extrinsic mechanisms of action and predictors of sensitivity and resistance mechanisms. Biomarker results from early phase studies will be leveraged to support inclusion of relevant biomarkers (including those that lead to patient selection) in Phase 2 and 3 studies.
Summary of Key Responsibilities
- Working collaboratively with diverse functional groups within Shattuck to define and implement the translational science objectives for clinical phase assets. The Director of Translational Medicine will collaborate with Clinical Scientists, Clinical Monitors, Regulatory and External CROs to review clinical trial documents including protocols and informed consent forms (ICFs) that detail objectives and clinical sample collection. The candidate will author relevant sections pertaining to translational science/ correlative studies for regulatory submissions to governmental agencies (e.g., FDA, NIH RAC, MHRA and EMA) as well as local bodies (e.g. IRB/EC).
- Vetting technologies and platforms offered by various vendors to interrogate defined hypotheses. Selecting vendors and overseeing assay development and 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 the clinical development strategy.
- Appropriately acquiring and interrogating of baseline, on-treatment and post-progression serum, PBMC and tumor samples. Lead the team to achieve timely completion of analysis.
- Proactively communicate on all assigned projects across stakeholders, including the clinical trial team, Shattuck management, CROs, collaborators, and academic and/or pharma partners. Author documents/presentations for internal and external audiences.
- Participate in training clinical sites on patient sample acquisition requirements. Additional responsibilities include communicating emerging translational science data to clinical sites and investigators.
- Work with the clinical and biometrics teams to author a study specific analysis plan and detail the workflow of analyses. Lead the data analysis and interpretation to inform future clinical trial/correlative study design and the communication of those results.
- 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. The Director of Translational Medicine may also draft white papers summarizing novel areas of immune/immune oncology for senior management.
- Candidate will have at minimum, one direct report (FTE). Candidate will be responsible for evaluating, hiring, and managing 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.
- MD/PhD, MD or PhD with at least 3 years of experience in immuno-oncology research with evidence of productivity as demonstrated by publications in peer-reviewed journals and/or abstracts at conferences.
- 2+ 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)
- Working knowledge of requirements for clinical trial assays used for patient selection
- Experience with clinical trial assay development and Investigational Device Exemptions (IDEs)
- Experience with companion diagnostic development
- 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
- 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.