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MBX Biosciences, Inc. · 1 day ago

Medical Director (Medical Monitoring)

United States

Full-time

Remote

Director/Executive

MBX Biosciences is a clinical-stage biopharmaceutical company focused on the discovery and development of novel precision peptide therapies. They are seeking an experienced Medical Director to lead medical monitoring activities across clinical development programs, ensuring patient safety and data integrity while collaborating with cross-functional teams to support clinical trials.

BiotechnologyHealth CareTherapeutics

Responsibilities

Drive development programs, collaborating with Program Management, Clinical Operations, Regulatory Affairs, and cross-functional teams, collaboratively designing our phase III pivotal study supporting regulatory submissions

Serve as a medical monitor for our clinical trial- ensuring high-quality evaluation of clinical and laboratory data, guiding decision-making on recruitment, study conduct and on dose escalation and early clinical signals of activity if appropriate to trial stage

Build and advance identified priority external relationships with KOLs and physicians who are clinical leaders and influencers to form a relevant and sustainable strategy reflective of patient, payor, and other US customer needs

Provide input and leadership in preparing global regulatory filings, including clinical sections of Investigator’s Brochures (IBs), Investigational New Drug (IND) applications, Clinical Trial Applications (CTAs), and New Drug Applications (NDAs)

Facilitate regular engagement with academic clinical investigators, support site initiation visits, and lead investigator meetings in a way that fosters collaboration, trust, and shared learning

Represent the company at scientific meetings and engage with key opinion leaders

Contribute to publications and presentations of clinical research findings

Partner with Pharmacovigilance to review and interpret clinical data, ensuring accuracy, context, and patient safety

Other responsibilities as assigned

Qualification

Medical monitoringClinical developmentRegulatory submissionsCross-functional collaborationScientific publication historyData interpretationCommunication skillsGxP guidelinesLeadershipTeam collaborationPresentation skills

Required

Advanced scientific degree (M.D., Ph.D., Pharm.D., or M.S.) with progressive experience in medical or scientific affairs within the pharmaceutical or biotechnology industry, or equivalent

Clinical development experience, preferably within metabolic, endocrine, or related therapeutic areas

Demonstrated expertise in the design, execution, and oversight of late-stage clinical trials, with a strong understanding of regulatory requirements, data interpretation, and cross-functional collaboration

Hands-on experience in medical monitoring, including oversight of clinical trial safety and data integrity

Proven track record of contributing to regulatory submissions and engaging with global health authorities

Demonstrated experience as a medical monitor with solid knowledge of GxP guidelines and clinical trial conduct

Robust scientific publication history and effective presentation skills

Exceptional communication abilities, with a talent for translating complex scientific concepts into clear, actionable insights

Strong collaborator with a history of success in cross-functional team environments