Shattuck Labs (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-279252 and SL-172154). 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 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.
About the Position
The Director of Nonclinical Development is responsible for leading IND-enabling activities from identification of a lead product candidate to authoring/approving research reports for incorporation to an IND. Specifically, this person will provide: design and have managerial oversight of safety/toxicology studies in a relevant species, oversee the design and execution of pre-clinical studies to support identification of a first-in-human dose selection, , and oversee all bioanalytical activities to support IND filings and ultimately BLA filings. The Director of Nonclinical Development will determine and mitigate organizational gaps and develop internal capabilities and outsourcing strategies to meet or exceed regulatory authorities' requirements and portfolio needs.
You will leverage your deep toxicology experience and contribute to overall strategy and prioritization of our programs. You will collaborate within a dynamic and entrepreneurial organization and leveraging the expertise of numerous external vendors. This role will report to the Vice President of Research and Development.
Summary of Key Responsibilities
· Strategically plan, manage, oversee, and/or execute many non-clinical activities required for candidate selection, IND enablement, and clinical support including, non-human pharmacology studies, toxicology studies, bioanalytical assay development and sample analysis.
- Use internal and external (CRO) resources to design, develop, troubleshoot, transfer, and monitor qualification/validation/reporting of PK/CK, PD, ADA, immunogenicity, and biomarker assays to support drug discovery and nonclinical development activities.
- Develop and integrate timelines and budgets for non-clinical activities with overall company timelines and corporate goals, in close coordination with Program Management, CMC, Clinical, Regulatory groups and other stakeholders.
- Successfully interact with other functional area experts in a project team environment to recommend the best course of preclinical development for a given program and defend those recommendations to executive management.
- Oversee CROs and other external resources and ensure quality results are delivered on time and within budget. This includes study design, protocol development, coordination of study materials, data interpretation, report review and approval.
- Work together with Shattuck Regulatory personnel to author relevant sections of regulatory submission documents for drugs, biologics and devices (e.g. INDs, NDA/BLA, MAAs, and 510Ks) as well as preclinical sections of Investigators Brochures, CTA applications, IMPDs, etc.
Required Qualifications and Skills
· PhD in immunology, cancer biology, cell biology, or related field.
· At least 5 years of related experience with deep expertise in preclinical development, including authoring of non-clinical study reports for regulatory submission.
· Proven ability to collaborate with other functional areas within the company.
· Excellent oral and written communication skills with strong technical writing experience required.
· Provides a vision and direction, initiates action and enables competence and effectiveness in others.
· Able to multi-task productively, applying time management processes and procedures effectively for on time delivery.
· Technically capable of determining what is wrong in complex situations and offering potential solutions, identifying root cause of a problem and working with others to correct problems.
· Works toward common goals by supporting, encouraging and sharing information with colleagues.
· Speaks, writes, listens and presents information in a logical and articulate manner.
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.