Clinical Scientist

About the role

MBX Biosciences is a clinical-stage biopharmaceutical company headquartered in Carmel, Indiana, with a secondary office in Burlington, MA. Our mission is to transform the lives of people impacted by endocrine and metabolic disorders through our novel precision peptides. Leveraging our proprietary Precision Endocrine Peptides (PEPs)™ platform, we are pioneering technology designed to overcome key limitations of existing therapies and enhance efficacy, tolerability, safety and convenience. Our team is advancing a pipeline of novel candidates with clinically validated targets, established endpoints for regulatory approval, and strong market potential. Our pipeline includes canvuparatide (MBX 2109) for the treatment of chronic hypoparathyroidism, currently preparing for Phase 3 development, and a growing obesity portfolio that includes MBX 4291 in Phase 1 development, MBX 5765, a next-generation amycretin prodrug designed for once-monthly-dosing, as well as MBX 6180, a GLP/GIP/GCGR triple agonist prodrug for once monthly dosing; all of which optimize our PEP platform. If you’re passionate about advancing innovative treatments for patients and shaping the future of precision peptide therapeutics, this is your chance to make a real impact alongside a fast-paced, growing, mission-driven team.

Responsibilities

• Provide clinical and scientific expertise to deliver clinical studies in early- and/or late-stage development.
• Responsible for the hands-on implementation and execution of assigned clinical studies under the supervision of a Director/Senior Director in Clinical Development.
• Support clinical studies in collaboration with other members of the cross-functional study team.
• Clinical Pharmacology studies may be in-scope based on company need.
• Provide clinical and scientific oversight of clinical study execution, from start-up to close-out and results reporting.
• Leading role in authoring clinical study protocols/amendments and related study documents (including but not limited to drug specific risk language, ICFs, clinical study training materials, pharmacy manual, laboratory manual, etc.) by translating the strategy and approved concept into executable and efficient clinical studies.
• Contribute to authoring various regulatory study documents, including clinical sections of IND/NDA and CTA submissions, investigator brochures, annual reports and updates, and clinical sections of health authority responses.
• Develop a clinical study execution plan in collaboration with cross-functional study leads.
• Share the responsibility for establishing and maintaining regular cross-functional study team meetings with the study Clinical Operations Lead.
• Contribute to the selection and management of study vendors, including but not limited to CROs, central laboratories/imaging, clinical sites, EDC, IRT, TMF, etc.
• Train internal and/or external study team members on medical and scientific aspects of the clinical study at SIVs and at other applicable forums.
• Review and monitor emerging clinical study data related to safety and efficacy (including but not limited to establishing the medical monitoring plan, conducting medical review, and documenting the outcome of medical review).
• Work closely with the Study Medical Lead and Director/Senior Director of Clinical Development to report clinical study progress and ensure timely communication of any identified medical or operational issues.
• Proactively identify and review emerging study issues by actively engaging with study CRO, vendors, and cross-functional study leads.
• Develop sound and strategic solutions to arising study issues and collaborate with pertinent study team members to ensure issue resolution.
• Support the review, analysis, and interpretation of clinical study results.
• Contribute to clinical study report development and ensure timely finalization.
• As needed, present clinical study data to internal and/or external stakeholders.
• Maintain