Director, Project Management (Drug Development)

Director, Project Management (Drug Development)at MBX Biosciences

Remote

Position Summary

We are seeking an exceptional Director, Project Management, who will play a critical role in coordinating and managing across multiple departments our complex drug development projects to successful completion.The ideal candidate will bring extensive experience in Pharma RD project management, a deep understanding of the end-to-end drug development process and a proven ability to deliver results in a fast paced, high stakes environment.This role demands a dynamic leader capable of coordinating cross functional teams, managing diverse stakeholders and navigating the complexities of global drug development.The successful candidate will be highly collaborative and have the ability to proactively partner cross-functionally, including but not limited to research and discovery, non-clinical, clinical, manufacturing, regulatory, finance, and the company leadership team. The incumbent in this role will need to exhibit excellent communication, interpersonal, and organizational skills, and the ability to work in a dynamic, fast-paced environment will be critical to success.

The person filling this role will report to the Chief Medical Officer and will be a key partner to the Asset Team Leader(s) in charge of the project(s).

Key Roles Responsibilities

• Lead the planning and execution of high impact RD projects from early-stage discovery through regulatory approval and market launch.
• Create and manage detailed and integrated development plans that account for all phases of drug development across RD functions with timelines, work plan (including interdependencies), budget, resources allocation and risk management strategies.
• Actively and effectively manage the delivery of project goals in accordance with the program strategy, with a strong focus on meeting critical milestones, managing scope changes while integrating project constraints.
• Monitor project progress and measure project performance to identify areas for improvement.
• Recommend/make adjustments as needed to ensure progress timelines and goals achievement.
• Proactively identify potential project risks and develop with the team comprehensive mitigation plans to overcome obstacles and ensure project success.
• Serve as the main point of contact for all project-related communications, fostering strong relationship with internal teams, and external partners.
• Facilitate project meetings, prepare minutes for select meetings, and track action items
• Facilitate effective collaboration across RD functional teams, ensuring alignment on project goals and priorities.
• Provide project updates on a consistent basis to various stakeholders, including the leadership team, about strategy, adjustments, and development progress.
• Ensure all projects activities comply with regulatory requirements including FDA, EMA and ICH guidelines
• Coordinate as needed the preparation of high-quality regulatory submissions
• Develop and manage in partnership with Finance project budget, detailed forecasting and reporting, with a keen focus on cost control and resource optimization, balancing project needs and organizational capacity.
• Champion a culture of continuous improvement, identifying and implementing best practices in project management and drug development.
• Stay abreast of industry trends, emerging technologies and regulatory changes, applying this knowledge to enhance project outcomes.
• Utilize advanced project management methodologies and tools to optimize project efficiency and effectiveness.

Job Requirements

• Bachelors degree in a life science, project management, or business discipline is required
• 10+ years of biotech, pharmaceutical, or life sciences project management experience, with at least 5 years of leadership experience
• Experience in drug development is required, with endocrine and/or rare disease experience preferred
• Prior experience with IND, NDA, and MAA submissions
• Demonstrated understanding of the drug development process including key disciplines involved in drug development (including but not limited to CMC, toxicology, clinical, drug-device combinations, regulatory filing activities).
• Strong knowledge of drug development regulations, including but not limited to GMP and GCP.
• Project management and analytical skills, including strong organization, prioritization, and problem-solving skills.
• Demonstrated ability to deliver results with high quality, on time, and within budget.
• Strong oral, verbal, and interpersonal communication skills with a bias toward action.
• Willingness and ability to build and maintain strong, cross-functional relationships within all levels of the department and throughout the organization
• Project management professional (PMP) certification preferred
• Proficiency in the use of project management tools and techniques (e.g., MS Project, MS Excel, MS PowerPoint, etc.)

Company Overview

MBX Biosciences, Inc. is a biopharmaceutical company focused on the discovery and development of novel precision peptide therapies for the treatment of endocrine and metabolic disorders. The company was founded by global leaders with a transformative approach to peptide drug design and development. Leveraging this expertise, the Company designed its proprietary Precision Endocrine Peptide, or PEP, platform to overcome the key limitations of unmodified and modified peptide therapies and to improve clinical outcomes and simplify disease management for patients. PEPs are selectively engineered to have optimized pharmaceutical properties, including extended time-action profiles and consistent drug concentrations with low peak-to-trough concentration ratios, consistent exposure to target tissues, and less frequent dosing.

The Company is advancing a pipeline of novel candidates for endocrine and metabolic disorders with clinically validated targets, established endpoints for regulatory approval, significant unmet medical needs and large potential market opportunities. The Companys pipeline includes its lead product candidate MBX 2109, in Phase 2 development for the treatment of chronic hypoparathyroidism (HP); MBX 1416, in Phase 1 development for the treatment of post-bariatric hypoglycemia (PBH); and an obesity portfolio that includes MBX 4291, as well as multiple discovery and pre-clinical candidates in development for the treatment of obesity.

The Company is supported by leading life science investors including Deep Track Capital, Driehaus Capital Management, Frazier Life Sciences, NEA, Norwest Venture Partners, OrbiMed, RA Capital Management, funds and accounts advised by T. Rowe Price Associates, Inc. and Wellington Management. MBX is based in Carmel, Indiana.

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