Director/Senior Director, MASH Project Management Lead
About The Position
About Altimmune : Altimmune (NASDAQ: ALT) is a late clinical-stage biopharmaceutical company developing therapies for patients with serious liver diseases. The Company's lead candidate, pemvidutide, is a unique dual-action therapy targeting both glucagon and GLP-1 receptors in a balanced 1:1 ratio in development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), alcohol use disorder (AUD), and alcohol-associated liver disease (ALD). For more information, please visit www.altimmune.com . Summary of Position : We are seeking a Director/Senior Director, MASH Project Management Lead, with hands-on experience conducting global clinical trials in metabolic dysfunction-associated steatohepatitis (MASH). This role will be responsible for the end-to-end execution of clinical studies, working closely with CROs, investigators, vendors, and internal cross-functional teams. Prior experience in global biopsy-confirmed MASH studies is strongly preferred. This role is ideal for someone who is a versatile professional, thrives in a fast-paced working environment, and is a dynamic leader. This role reports to the Vice President, Global Program Lead, and will play a key role in the development of pemvidutide for the treatment of MASH.
Requirements
- Bachelor's degree in life sciences or related field (advanced degree preferred)
- 10+ years of hands-on clinical operations experience
- Direct experience managing global clinical trials
- Strong knowledge of ICH-GCP and global clinical trial regulations
- Demonstrated ability to work independently and manage multiple priorities
- Prior involvement in inspections or audits (FDA, EMA, MHRA)
- Ability to build and improve clinical operations processes from the ground up
- Travel up to 25% of the time
- Hands-on, lead by example, goal-oriented, growth mindset
- Strong organizational and project management skills
- Excellent communication and presentation skills and stakeholder management abilities
- Proactive problem-solver
- Team-oriented with a strong sense of ownership
Nice To Haves
- Prior experience in global biopsy-confirmed MASH studies preferred
Responsibilities
- Clinical Trial Execution Manage and oversee CROs and third-party vendors, including adherence to the scope of work contracted
- Manage day-to-day clinical operations activities while ensuring timelines, quality, and budget adherence
- Serve as the primary operational point of contact for external partners
- Support the development and maintenance of key trial documents (e.g., protocols, ICFs, monitoring plans, TMF plans)
- Ensure trials are conducted in compliance with ICH-GCP, FDA, MHRA, EMA, and local regulations
- Offers therapeutic and operational guidance on study protocols and execution strategies
- Monitors trends in clinical operations and advises teams on proactive responses to mitigate risks
- Oversee Trial Master File (TMF) completeness and inspection readiness
- Collaborate with investigators and site staff to address enrollment, compliance, and quality issues
- Identify and mitigate operational risks impacting site performance.
- Cross-Functional Collaboration Work closely with internal partners within Clinical Operations, Clinical Development, Quality, Regulatory Affairs, Data Management, Biostatistics, and Safety
- Contribute to process development and continuous improvement
- Fosters an inclusive, high-performing team culture, promoting collaboration, accountability, and resilience
- Champions a culture of critical thinking, innovation, and operational excellence.
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What This Job Offers
Job Type
Full-time
Career Level
Director
