Shattuck Labs, Inc. (NASDAQ: STTK) 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, with three ongoing Phase 1 clinical trials. Compounds derived from Shattuck’s proprietary Agonist Redirected Checkpoint, ARC®, platform simultaneously inhibit checkpoint molecules and activate costimulatory molecules within a single therapeutic. The company’s SL-172154 (SIRPa-Fc-CD40L) program, which is designed to block the CD47/SIRPa checkpoint interaction and simultaneously agonize the CD40 pathway, is being evaluated in two Phase 1 trials. A second product candidate, SL-279252 (PD1-Fc-OX40L), is being evaluated in a Phase 1 trial in solid tumors or lymphomas. 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. For more information, please visit: www.ShattuckLabs.com.
About the Position
The candidate is expected to have exceptional technical and scientific leadership skills to develop and implement clinical pharmacology and modeling and simulation strategies, including pharmacometrics, to advance Shattuck Labs’ drug candidates across various stages of development. The candidate will be responsible for preclinical and clinical pharmacology/DMPK, PK/PD analyses, and advanced data analytics. The candidate will collaborate with the development teams on preclinical pharmacology, toxicokinetics, and clinical pharmacology and pharmacometrics strategy, develop study protocols, analyze and interpret pharmacokinetic data, write pharmacology study reports, and relevant sections of regulatory documents. This role will also involve working closely with CROs and study collaborators to execute clinical development plans and will serve as the pharmacology representative at regulatory agency meetings.
• Provide preclinical PK, toxicokinetics, and clinical PK/PD expertise to project teams and clinical trials.
• Develop and implement clinical pharmacology and pharmacometric plans to drive Shattuck Labs biologics programs through all the stages of development.
• Contribute to progression of Shattuck Labs drug candidates through major milestones including performing necessary analysis and authoring of sections of IND/CTA, regulatory meeting materials (e.g., EOP1, EOP2) and marketing applications.
• Provide pharmacometrics and advanced data analytics support to the clinical and translational medicine group.
• Conduct PK/PD and exposure-response analyses using modeling and simulation techniques to support target identification, lead candidate selection, dose recommendation, trial design, Go/No-Go decisions, regulatory submission documents, and publications.
• Responsibility for design and conduct of Clinical Pharmacology studies.
• Collaborate with other functional areas including Research, Clinical Development, Biostats, Translational Medicine, Development Operations, Regulatory and Quality Assurance to deliver on project team and corporate objectives.
• Represent Clinical Pharmacology function as a member of program, clinical sub-team, clinical trial working teams by contributing to clinical development strategy, clinical trial design, clinical study protocols, executing and coordinating clinical trial conduct and finalizing clinical study reports. Take accountability for clinical pharmacology deliverables.
• Work with other scientific experts to evaluate new methods to maintain cutting edge techniques, models, and capabilities.
• Drive external scientific visibility and publication objectives.
• Assure the implementation and adherence to GXPs compliance, and regulatory standards in the clinical pharmacology group.
• Manage CROs for DMPK and Clinical Pharmacology related studies and activities inclusive of developing study timelines, objectives and budgets, ensuring accuracy of project delivery and pro-actively identifying hurdles and providing solutions.
• Actively participate in cross-departmental teams, company-wide initiatives, and work streams.
• PhD or PharmD or MD in pharmaceutical sciences, pharmacology, or related disciplines such as pharmacokinetics.
• Required Experience
• 8-15 years' experience in clinical pharmacology and pharmacometrics. The level (Director or Sr. Director) and responsibilities of the position will depend on the individual's experience.
• Preclinical and clinical development of large molecules (e.g., monoclonal antibodies, Fc-fusion proteins, bispecific molecules)
• Submission of IND/BLA and global marketing applications
• Direct interaction with the FDA and international regulatory authorities.
• Contributions to translational science objectives
• Broad familiarity with the drug development process, particularly for oncology
• Prior experience working with and providing primary oversight of CROs for DMPK and Clinical Pharmacology related activities.
• Demonstrated ability to contribute successfully in a multi-disciplinary team environment.
• Expertise in pre- and clinical pharmacology, hands-on modeling and simulation skills using NONMEM, R WinNonlin, SimCYP and/or other modeling and simulation software.
• Experience with population PK models, advanced mechanistic PK/PD models, disease models, PBPK models is highly preferred.
• Experience in nonclinical pharmacology and translational medicine is preferred.
• Understanding of pharmacodynamic endpoints of immunotherapies.
• Excellent interpersonal, verbal and written communication skills and the ability to convey complex technical information clearly.
• Ability to communicate and collaborate with other functional areas including biostats, drug discovery, nonclinical safety assessment, CMC, clinical development, quality assurance and regulatory affairs.
• Prior experience of impact on drug development through quantitative approaches with strong scientific leadership skills and the ability to influence.
• Ability to develop and deliver effective presentations and written/oral communications.
• Highly skilled in the ability to work with ambiguity and complexity and can continuously modify options and solutions without complete information.
• Ability to adapt, work through conflicts, and persuasively influence outcomes.
• Thrives in a fast-paced business environment.
• Applied knowledge of GLP and GCP regulations.