Clinical Scientist (Late Stage)

MBX Biosciences, Inc.; Burlington (MA); Híbrido; USD 140.000 - 190.000; Jornada completa

Descripción de la vacante

MBX Biosciences, Inc. is seeking a Clinical Scientist to deliver studies in early- and late-stage development. You will oversee hands-on study execution under supervision and collaborate with a cross-functional team to drive medical and scientific excellence.

The role involves protocol authoring, regulatory support, vendor management, and ongoing safety and efficacy assessment, with hybrid in-office work. A strong background in clinical pharmacology and GxP is preferred.

Formación

• 3+ years of hands-on early- and/or late-stage clinical development experience is required.
• Clinical research background in metabolic diseases is preferred.
• Understanding of drug development from pre-IND through registration.

Responsabilidades

• Provide clinical and scientific oversight of study execution from start-up to close-out.
• Lead protocol development and amendments translating strategy into executable studies.
• Contribute to regulatory submissions and clinical sections of IND/NDA filings.
• Develop a clinical study execution plan with cross-functional leads.
• Coordinate regular cross-functional study team meetings with the Clinical Operations Lead.
• Assist in vendor selection and management (CROs, labs, sites, EDC, IRT, TMF).
• Train internal and external team members on medical and scientific aspects at SIVs and other forums.
• Monitor emerging safety and efficacy data and document medical reviews.

Conocimientos

Clinical development

Regulatory strategy

Cross-functional leadership

Medical writing

Study management

Communication

Educación

PhD, PharmD, RN, NP degree

Herramientas

EDC

Microsoft Word

Excel

PowerPoint

Descripción del empleo

Working with Us

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.

Working with Us

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. To learn more, visit our website mbxbio.com and follow us on LinkedIn.

What You’ll Do

The Clinical Scientist will provide clinical and scientific expertise to deliver clinical studies in early- and/or late-stage development. This individual will be responsible for the hands-on implementation and execution of assigned clinical studies under the supervision of a Director/Senior Director in Clinical Development. This individual will 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 heath 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 current knowledge of pertinent therapeutic area(s)
• Other responsibilities as assigned.

What You Bring

• Degree in Life Sciences (PhD, PharmD, RN, NP) with at least 3 years of hands-on early- and/or late-stage clinical development experience in a pharmaceutical or biotechnology organization is required. Late-stage clinical development experience preferred.
• Clinical research background in metabolic diseases is preferred.
• Understanding of the drug development process from pre-IND through registration.
• Understanding of drug development functional areas, including preclinical, clinical pharmacology, regulatory, pharmacovigilance, drug supply, biometrics (data management, biostatistics, programming), and clinical operations.
• Ability to understand, interpret, and communicate clinical information including clinical study data, literature reviews, and current treatment practices to inform decision-making and clinical strategy.
• Candidates must possess effective communication and influencing skills across functions.
• Critical traits for success include strategic and proactive thinking, strong scientific and analytical skills, decisiveness and the ability to perform as a respected team member.
• Ability to work effectively in a collaborative and highly matrixed team environment where results are achieved through influence, cooperation, and the incorporation of multiple points of view.
• Independently motivated, detail oriented, and good problem-solving ability.
• Excellent organizational skills, with an ability to embrace change and multi-task in an extremely fast-paced environment.
• Proficient knowledge of GCP/ICH.
• Proficient in Microsoft Word, Excel, PowerPoint, Electronic Data Capture.

Travel & In Office Presence

You will be expected to travel periodically based on the needs of the business, including attendance at Together Weeks, Together Days, and functional meetings as requested by the team. Employees are expected to work on hybrid schedules, consistent with local office practices and the terms of the companies in office policy as in effect from time to time.

EEO Statement

MBX Biosciences is an Equal Opportunity Employer and is committed to treating all applicants fairly without discrimination. We welcome applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law.