Director, Medical Process and Knowledge Management

Director, Medical Affairs Process and Knowledge Management

About Madrigal: Madrigal is a biopharmaceutical company pursuing novel therapeutics for non‑alcoholic steatohepatitis (NASH), also known as metabolic dysfunction associated steatohepatitis (MASH). Our first therapy, Rezdiffra (resmetirom), was granted accelerated approval by the U.S. Food and Drug Administration (FDA) for the treatment of adults with NASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis) and is being studied in a Phase 3 trial for the treatment of NASH with compensated cirrhosis.

The Director, Medical Process and Knowledge Management is an integral member of the Global Operations and Medical Excellence Leadership Team providing oversight of the Medical Affairs (MA) Standard Operating Procedures (SOPs)/Policies and Knowledge Management capability. As the point of contact within the organization, you will be responsible for leading the effort to assess the current state of SOPs, policies, and work instructions and, based on the assessment, create a plan to create, maintain, review and train on all documentation.

You will be expected to manage these projects with the goal of linking global and local SOPs and performing quality and compliance functional monitoring. As leader of the Knowledge Management function, you will be responsible to create, manage and monitor role/activity‑based curricula and to develop general department onboarding, and develop/maintain core job descriptions.

• Lead complex projects to create, maintain, review and train on SOPs/policies that often involve multiple internal and external stakeholders
• Accountable for planning, orchestrating, and delivering the SOP initiatives including global and local Medical Affairs SOPs, as appropriate
• Review and revise SOPs on a routine basis including process maps, forms, templates, guidelines and supporting documentation when appropriate
• Develop, collect and disseminate relevant metrics associated with SOP deployment and training
• Align current and planned MA SOPs with the R&D Quality Group
• Liaise with the R&D Quality Group to ensure that SOPs and policies are aligned with R&D standards and systems
• Develop and implement a framework for maintaining controlled documents for Medical Affairs, in line with requirements of the Madrigal organization
• Serve as an ambassador for MA Standards throughout the organization and communicate the value and importance of MA SOPs/Policies and respond to questions as needed
• Prepare for and support audits and inspections as it relates to SOPs/Policies and training/curriculum‑related findings
• Collaborate within MA to define standard MA roles and training needs related to policies, SOPs, systems, and core role‑based activities (excluding scientific training)
• Define and monitor required training completion metrics for individual learning assignments and organizational compliance
• Lead MA onboarding program (i.e., development, ongoing maintenance) and monitor monthly analytics
• Create, maintain, and update job descriptions for core MA roles in conjunction with subject matter experts for each identified role
• Maintain Learning Management System

• Bachelor’s Degree in life sciences, business or healthcare;
  Master’s degree preferred.
• 7+ years of relevant Medical Affairs experience (e.g., Knowledge Management, SOPs/Policy expertise, Medical Operations)
• Familiarity with learning‑management systems and execution of training assignments and related processes and Standard Operating Procedures
• Strong personal integrity and high ethical standards
• Ability to organize, prioritize, and work effectively in a constantly changing, ambiguous environment and to motivate a team to do the same
• Experience leading cross‑functional, global initiatives in a complex matrix environment, with excellent networking and cross‑functional management skills
• Strong decision‑making, problem‑solving, and analytical skills with the ability to apply practical solutions to complex issues
• Ability to work independently while escalating risks and issues as appropriate
  
  Experience working within…