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Mbx Biosciences Inc

7 open roles indexed with location, benefit, and apply-link signals where available.

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  • Manager, SOX Compliance

    Carmel, Indiana

    unspecified Salary not disclosed

    Manager, SOX Compliance Carmel, Indiana Position Summary We are seeking a Manager, SOX Compliance and Accounting, specializing in Sarbanes Oxley (SOX) compliance and project accounting, to join our finance and accounting team. Reporting to the Assistant Controller, this individual will be responsible for overseeing the initial buildout, ongoing maintenance and testing of the Company's SOX compliance program in anticipation of SOX 404b compliance requirements, as well as accurate and timely preparation of monthly project accounting and other month-end accounting responsibilities as needed. This role requires strong leadership skills, extensive knowledge of SOX compliance, US GAAP, COSO internal control frameworks and the ability to manage complex accounting processes. Communication, organizational skills, and attention to detail, as well as the ability to multi-task, are key to successful incumbents consistently functioning at the highest level with the utmost regard for the MBX's mission & values. Key Responsibilities Including but not limited to: - Manage the buildout of the Company's SOX Compliance program, including the identification of entity-level controls, process-level controls, and ITGCs. - Conduct ongoing risk and control assessments by identifying financial reporting risks, evaluating entity-level and process-level controls, and assessing IT general and application controls. - Lead internal controls walkthroughs and testing. - Maintain and improve SOX documentation, including risk control matrices, process flows and test procedures. - Assist with managing and coordinating the external Audit team as it relates to SOX Compliance. - Recommend and implement changes to strengthen internal controls and financial processes, as needed. - Assist with major project

  • Director, Business Development

    Burlington, MA

    unspecified Salary not disclosed

    Director, Business Development Burlington, MA Position Summary MBX Biosciences is looking to hire a Director of Business Development who, in partnership with our Chief Business Officer, is responsible for identifying, developing, and scaling revenue‑generating partnerships, growth initiatives, and new business development opportunities. This role plays a critical part in shaping the company's growth strategy, expanding market presence, and building long‑term value through strategic relationships. Reporting to the Chief Business Officer, the Director of Business Development works cross‑functionally with R&D, Commercial, Finance, and Legal to evaluate opportunities, structure partnerships, negotiate agreements, and ensure successful execution. The ideal candidate combines strong scientific acumen, commercial instincts, analytical rigor, executive presence, and a track record of closing complex, high‑value deals. Key Responsibilities - Develop and execute the company's business development strategy in alignment with overall growth and revenue objectives. - Along with our Chief Business Officer, identify, evaluate, and pursue, partnerships, and revenue opportunities to expand the company's footprint. - Lead cross-functional due diligence, prepare partnering materials, terms sheets, conduct technical and business evaluations, market research, competitive analysis, and financial modeling to inform strategic decisions and investment priorities. - Lead competitive intelligence efforts, including monitoring competitor activity, market trends, and emerging threats or opportunities - Represent the company at industry events, partnering and scientific/medical conferences, and networking forums, strengthening brand presence and generating new opportunities. - Serve as a trusted advisor internally and externally, providing sound judgment, strategic insight, and professionalism in all interactions. - Other responsibilities as assigned Education & Qualifications - Bachelor's

  • Associate Director, Project Management (Late Stage/Commercialization)

    Burlington, MA

    unspecified Salary not disclosed

    Associate Director, Project Management (Late Stage/Commercialization) Burlington, MA Position Summary The Associate Director (AD), Project Management is responsible for leading complex, high-impact asset programs and enterprise initiatives across the full product lifecycle-from discovery and development through late-stage development, launch readiness, and commercialization. This role ensures alignment with organizational strategy, portfolio priorities, and value creation objectives. The AD will partner closely with and co-lead strategic planning, scenario analysis, and critical decision-making with the Project Leads (DT/ADT/ACT Leads) and senior functional leaders. Reporting to the Head of Portfolio and Project Management, the AD provides strategic leadership, governance, and executional excellence, ensuring cross-functional teams operate effectively, decisions are data-driven, and programs advance in accordance with the MBX operating model. This role requires a seasoned leader with strong enterprise mindset, exceptional communication and influencing skills, and the ability to guide cross-functional teams in a fast-paced, evolving environment. Key Responsibilities - Lead and oversee MBX's asset and enterprise project plans across development and commercialization, including scope, timelines, milestones, deliverables, resourcing, risks, budgets, key stage-gate and Go/No-Go decisions. - Drive end-to-end execution of project plans, manage and update cross-functional timelines, proactively identify potential project risks, and develop mitigation and contingency plans with the team to overcome obstacles and ensure project success. - Partner closely with Asset Commercialization Leaders for cross-functional commercialization and launch readiness planning, including integration of clinical, regulatory, CMC, supply chain, pricing & market access, medical affairs, sales, and commercial strategy activities. - Serve as a strategic thought partner to DT/ADT/ACT Leads, supporting long-range

  • (Associate) Director, Medical Writing

    Burlington, MA

    unspecified Salary not disclosed

    (Associate) Director, Medical Writing Burlington, MA Position Summary MBX Biosciences is seeking an experienced and motivated Associate Director / Director of Medical Writing to support and help grow the Medical Writing function. This full-time role will play a key part in delivering high-quality clinical and regulatory documentation and contributing to the development of efficient medical writing processes across the organization. The successful candidate will oversee the preparation of clinical and regulatory documents while collaborating closely with cross-functional partners, including Clinical Development, Regulatory Affairs, Quality, and Program Management. This role reports to the Senior Director of Medical Writing and will contribute to shaping medical writing capabilities as the company continues to grow. Key Responsibilities - Oversee the preparation, review, and finalization of clinical and regulatory documents, including clinical study protocols, clinical study reports, investigator brochures, and regulatory submissions. - Ensure documents are scientifically accurate, clear, and compliant with applicable regulatory guidelines, company standards, and timelines. - Collaborate with clinical, regulatory, and scientific teams to gather and interpret data and ensure effective communication of complex scientific information. - Contribute to the development and maintenance of medical writing processes, templates, and best practices to improve quality and efficiency. - Participate in cross-functional meetings as the medical writing representative and provide input on document strategy and planning. - Manage project timelines and coordinate resources to support timely document delivery. - Stay current with regulatory guidance, industry trends, and best practices in medical writing. - Other responsibilities as assigned. Qualifications - Advanced degree in life

  • Senior Project Manager (Early Phase Development)

    Burlington, MA

    unspecified Salary not disclosed

    Senior Project Manager (Early Phase Development) Burlington, MA Position Summary The Senior Project Manager (Sr. PM) is responsible for supporting complex, high-impact asset programs/projects and enterprise projects from initiation through delivery, ensuring alignment with organizational goals and strategic priorities. The Sr. PM will be responsible for co-leading strategic planning and decision-making processes with the DT/ADT/ACT Lead. Reporting to the head of Portfolio and Project Management, this role will ensure that cross-functional teams operate effectively, promote a positive team dynamic, and support the MBX operating model. This role requires strong leadership, exceptional communication skills, and the ability to manage cross-functional teams in a fast-paced environment. Key Responsibilities - Build and maintain MBX's asset and enterprise project plans that include scope, timelines, milestones, deliverables, key Go/No-Go decision points, resources, risks, and budgets. - Drive the execution of project plans, manage and update cross-functional timelines, proactively identify potential project risks, and develop mitigation and contingency plans with the team to overcome obstacles and ensure project success. - Support and manage cross-functional teams and meetings, which involve scheduling, preparing agendas, taking minutes, and tracking action items. - Facilitate decision-making and resolve conflicts efficiently. - Recommend and adjust plans as needed to ensure timeline progress and goal achievement. - Lead and motivate cross-functional teams to achieve project goals. - Review and provide feedback on program-level strategy related documentation such as regulatory meeting packages. - Serve as the main point of contact for all project-related communications and reporting, fostering strong relationships with internal teams and external

  • Director, Regulatory

    Greater Boston Area

    unspecified Salary not disclosed

    Director, Regulatory Greater Boston Area Position Summary The Director of Regulatory Affairs at MBX Biosciences will lead and execute global regulatory strategies that support the development and approval of MBX's clinical stage and early-stage programs. This high visibility role is responsible for developing and executing global regulatory strategies while leading the development and submission of critical regulatory filings-including INDs and CTAs-in alignment with evolving health authority expectations. In addition, this role will provide strategic regulatory leadership across MBX's early development portfolio, with a particular focus on obesity programs, ensuring proactive, scientifically grounded regulatory input from discovery through clinical advancement. Key Responsibilities - Provide regulatory leadership and strategic guidance across MBX's ‑early-stage development portfolio, ensuring regulatory considerations are integrated from discovery through ‑IND enabling activities. - Partner closely with R&D and Clinical teams to shape regulatory strategies for MBX's obesity portfolio, supporting efficient progression toward first‑in‑human studies and downstream clinical development. - Design and execute comprehensive global regulatory strategies and plans for assigned programs. - Develop and maintain proactive risk assessment and mitigation plans in collaboration with cross-functional teams and senior management. - Ensure timely and effective communication of regulatory developments to project teams, leadership, and key stakeholders, using sound judgment and professionalism. - Lead the regulatory sub-team and serve as the primary Regulatory Affairs representative on asset development teams. - Continuously expand therapeutic area knowledge to enhance strategic messaging and the quality of global regulatory submissions. - Act as a liaison with health authorities, including leading and managing FDA meetings.

  • Associate Director, Regulatory CMC

    Greater Boston Area

    unspecified Salary not disclosed

    Associate Director, Regulatory CMC Greater Boston Area Position Summary MBX Biosciences is advancing a pipeline of innovative therapies designed to improve the lives of patients with endocrine disorders. We are growing our Regulatory Affairs organization and are seeking a proactive and detail‑oriented professional to support global Regulatory CMC activities across our clinical programs. This is an exciting opportunity to contribute to high‑impact development efforts within a fast‑moving, science‑driven biotech environment. In this role, you will support the development, execution, and maintenance of CMC regulatory strategies to enable successful global submissions and ongoing clinical development. Working closely with the Senior Director of Regulatory CMC and cross‑functional partners, you will ensure that all Regulatory CMC deliverables meet global requirements and are submitted to Health Authorities with the highest level of quality. Key Responsibilities - Collaborate and provide support for Regulatory CMC activities across global clinical trials, ensuring adherence to regional requirements (FDA, EMA, APAC, etc.). - Partner with internal stakeholders to develop and author CMC sections for regulatory submissions, including INDs, IMPDs/CTAs, NDAs, MAAs, and related amendments, as well as responses to Health Authority (HA) inquiries. - Evaluate changes to clinical trial materials or manufacturing processes and prepare the appropriate documentation for regulatory updates or amendments. - Identify regulatory risks, manage Regulatory CMC timelines and deliverables, and ensure timely submission of high‑quality CMC dossiers to support clinical development. - Deliver regular updates to senior leadership on regulatory activities, submission status, and key milestones. - Communicate CMC regulatory strategies, risks, and critical issues