Senior Clinical Scientist, Late-Stage Trials - Metabolic

Regulatory Jobs; Burlington (MA); Hybrid; USD 140,000 - 210,000; Full time

Job summary

MBX Biosciences is seeking a senior clinical development professional to provide expert medical oversight across the full lifecycle of clinical studies, from initiation to reporting. You will lead protocol authoring, contribute to IND/NDA/CTA submissions, and collaborate with cross-functional teams to ensure rigorous study design and regulatory alignment.

The role requires a Life Sciences degree with 3+ years in clinical development, with preference for metabolic disease experience.

Qualifications

• Degree in Life Sciences (PhD, PharmD, RN, NP) with 3+ years in clinical development.
• Experience in early- and/or late-stage development in pharma/biotech.
• Experience with metabolic diseases preferred.
• Understanding of the drug development process from pre-IND through registration.
• Strong communication and influencing skills.
• Ability to work in a collaborative, matrixed team environment.
• Proficient in GCP/ICH; MS Word, Excel, PowerPoint; EDC experience.

Responsibilities

• Provide clinical and scientific oversight of clinical study execution from start-up to close-out and results reporting.
• Lead authoring of clinical study protocols/amendments and related study documents.
• Contribute to regulatory study documents including IND/NDA and CTA submissions and investigator brochures.
• Develop a clinical study execution plan with cross-functional study leads.
• Establish and maintain regular cross-functional study team meetings.
• Contribute to vendor selection and management (CROs, labs, sites, EDC, IRT, TMF).
• Train internal/external team members on medical/scientific aspects of the studies.
• Review and monitor emerging study data for safety and efficacy, including medical monitoring plans.
• Support review, analysis, and interpretation of study results; contribute to SARs and final reports.
• Present clinical study data to internal/external stakeholders as needed.
• Maintain current knowledge of therapeutic areas and regulatory expectations.

Skills

Clinical development

Regulatory submissions

Cross-functional collaboration

Medical writing

GCP/ICH proficiency

Data interpretation

Communication

Education

Life Sciences degree (PhD/PharmD/RN/NP)

Job description

MBX Biosciences is seeking a senior clinical development professional to provide expert medical oversight across the full lifecycle of clinical studies, from initiation to reporting. You will lead protocol authoring, contribute to IND/NDA/CTA submissions, and collaborate with cross-functional teams to ensure rigorous study design and regulatory alignment.

The role requires a Life Sciences degree with 3+ years in clinical development, with preference for metabolic disease experience.