Director/Senior Director, MASH Project Management Lead

About the Role:
The Director or Senior Director, MASH Project Management Lead is responsible for overseeing the end-to-end execution of global clinical trials focused on metabolic dysfunction-associated steatohepatitis (MASH). This leadership role partners cross-functionally with clinical development, regulatory, quality, and operational teams to ensure successful study delivery within timelines, budget, and regulatory compliance. The ideal candidate brings deep expertise in global clinical operations, strong project leadership skills, and hands-on experience managing complex clinical programs in the biotechnology or pharmaceutical industry.

Responsibilities:

• Lead and oversee global clinical trial execution for MASH programs from study start-up through closeout.
• Manage CROs, vendors, and external partners to ensure adherence to scope, timelines, and budget.
• Serve as the primary operational point of contact for clinical trial stakeholders and external collaborators.
• Develop and maintain key clinical trial documents, including protocols, informed consent forms, monitoring plans, and Trial Master File strategies.
• Ensure compliance with ICH-GCP guidelines and global regulatory requirements, including FDA, EMA, and MHRA standards.
• Monitor clinical operations metrics and identify risks, implementing mitigation strategies to ensure study success.
• Oversee Trial Master File completeness and inspection readiness activities.
• Collaborate with investigators and site teams to address enrollment challenges, compliance issues, and data quality concerns.
• Partner cross-functionally with Clinical Development, Regulatory Affairs, Data Management, Biostatistics, Quality, and Safety teams.
• Contribute to clinical operations process development and continuous improvement initiatives.
• Lead project management activities including timelines, budgets, resource planning, and strategic execution.
• Foster a high-performance, collaborative team culture that promotes accountability, innovation, and operational excellence.

Qualifications:

• Bachelor's degree in Life Sciences or a related field required, advanced degree preferred.
• Ten or more years of clinical operations experience within the biotechnology or pharmaceutical industry.
• Demonstrated experience managing global clinical trials across multiple regions.
• Strong knowledge of ICH-GCP guidelines and global regulatory requirements.
• Proven ability to lead cross-functional teams and manage complex clinical programs.
• Experience overseeing CROs, vendors, and clinical trial budgets.
• Strong project management, organizational, and problem-solving skills.
• Excellent communication and stakeholder management abilities.
• Ability to work independently and manage multiple priorities in a fast-paced environment.
• Willingness to travel up to 25 percent as required.

Desired Qualifications:

• Advanced degree such as MS, PhD, PharmD, or MBA.
• Direct experience managing biopsy-confirmed MASH clinical trials.
• Prior experience supporting regulatory inspections or audits from FDA, EMA, or MHRA.
• Experience building or optimizing clinical operations processes in a growing organization.
• Background in metabolic diseases, hepatology, or related therapeutic areas.