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Job: VP of Translational Medicine, Shattuck Labs, Austin, TX/RTP, NC
VP of Translational Medicine
Austin, TX/RTP, NC 78703 United States
Research and Development
Shattuck Labs is a rapidly growing biotechnology company developing a breakthrough immunotherapy platform which is being developed to improve survival for patients battling cancer and inflammatory disease. Shattuck’s proprietary technology represents the next evolutionary step in cancer therapy by endowing one molecule with multiple functions with applicability across the entire spectrum of human disease. Shattuck Labs, based in Austin, Texas, is a privately-held biotechnology company founded in 2016. The R&D hub for Shattuck Labs is based in Research Triangle Park, NC.
Shattuck is establishing a state-of-the-art biomarker discovery and immune monitoring laboratory in Austin, Texas. We are seeking a VP-level candidate to serve as the leader of this effort and someone who can build a translational research team at Shattuck to support multiple clinical programs. Specifically, the role is to work cross-functionally with both the CSO and CMO to develop and implement biomarker strategies for transitioning programs from the preclinical stage to clinical Phase 1 and Proof of Concept (PoC) across all therapeutic areas. In partnership with the CMO, CSO and supporting functions, the incumbent will explore potential therapeutic applications of novel bi-functional Fc fusion proteins in support of generating a strategy for clinical development.
The VP of Translational Medicine will be a member of the senior management team at Shattuck, and will serve as laboratory site head for the Austin, Texas facility. Shattuck will provide industry competitive salary, equity and bonus, as well as a competitive benefits package including: health, dental, vision, 401K and vacation time.
•Develops the Translational Research Plan for First in Human (FIH) and POC strategy
•Establishes the Translational Medicine Laboratory and Team to support the Translational Research Plan
•Guides company strategy to determine which core competencies should be built internally versus outsourced to third parties to support the Translational Research Plan
•Prepare and assure the overall quality of regulatory submissions (e.g., Investigational New Drug (IND) and Clinical Trial Authorization (CTA) for submission to Health Authorities
•Works with the CMO and CSO as a representative to Health Authorities (HA) and invite appropriate experts (internal and external) together with focus on early development
•Identifies and hires managers and operators within each core competency area needed to support the Translational Research Plan
•Serves as a senior Shattuck representative to medically related experts and organizations (includes CROs, Advisory Boards)
•Makes recommendations regarding endpoints, design, safety evaluations and initial dose selections
•Works with the CSO and CMO to oversee pre-clinical toxicology study design and analytical method support and development
•Assures overall quality of appropriate aspects of Clinical Plan, Study Synopses, Study Protocols, and Clinical Trial Reports (CTRs) and Summaries (e.g. slide format and executive summaries)
•Prepares and implement project/protocol specific training programs and training material for internal staff and clinical trial sites as needed.
•Management Responsibility: 3-6 direct reports
•Budget & Financial Responsibility: recommending and conducting projects within budgetary guidelines
•Contribute broad drug development and scientific knowledge to PIs, Project Teams, and Management Reviews
Qualification and Education Requirements
The successful candidate has the ability to thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient. Excellent leadership, communication and collaboration skills in a cross-functional, multi-faceted environment. Other requirements are:
• MD or MD/PhD or PhD (or equivalent) with 6+ years of biotechnology or pharmaceutical drug development experience
•Capable of working independently within a highly matrixed environment to support Team and Corporate goals
•Significant experience in clinical pharmacology, immunopathology and tumor immunology
•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
•Experience linking preclinical PK, PD, efficacy relationships and translation of findings to clinical trials; development of biomarkers for pharmacodynamic assessment and patient selection strategies
•Basic understanding of companion diagnostic development.
•Knowledge of human sample management requirements
•Design of Phase 1 and Phase 2a trials and/or significant prior translational medicine experience in related fields
•Basic Science and/or Clinical research experience in a medical specialty with a proven record of quality publications
•Experience in constructing and writing regulatory filings (IND, CTA, etc.), authoring biomarker portion of clinical protocols, study procedures manuals and clinical study reports
•Experience interacting with investigators and clinical trial sites for successful implementation of biomarker plan
•Strategic thinking, creativity, ability to work in a highly dynamic and innovative environment, recognized leadership in clinical research and ability to network with and influence external experts
•Demonstrated success in building, leading and managing and internal team as well as managing interactions with external CROs, consultants and other contract organizations
•Ability to thrive in a fast-paced and dynamic environment with frequent course corrections
•Excellent interpersonal skills, verbal and written communication skills
•Strong organizational skills and attention to detail
•High level of self-motivation, entrepreneurial spirit, and flexibility (openness to take on additional responsibilities as needed)
•Ability to work with minimal supervision and good independent judgment.
•Strong team player that has a customer service approach and is solution oriented.
•Excitement about the vision and mission of Shattuck Labs.
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