What are the responsibilities and job description for the Director/Senior Director, Medical Operational Excellence Lead position at System One Holdings, LLC?
Job Title : Director / Senior Director, Medical Operational Excellence Lead
Full time permanent position - Direct with a global pharmaceutical company
Location : North NJ
Hybrid Role - onsite 2-3 days per week
Must have :
US Launch experience
Building out medical affairs strategies
Overview :
The Medical Operational Excellence Lead is responsible for driving continuous improvement initiatives, ensuring high standards of operational performance, ensuring Medical Affairs strategic projects are coordinated and executed timely, and fostering a culture of excellence within medical and clinical operations. This role involves collaborating with cross-functional teams to streamline processes, enhance productivity, and implement best practices, particularly but not exclusively in the area of field medical excellence, medical insights process, medical education development, and adopting innovative approaches to enhance impact and create efficiencies.
Detailed Description :
Partner with the VP Head of Medical Affairs and the Medical Affairs Leadership Team (LT) on prioritized projects aimed at enhancing the alignment and impact of Medical Affairs within the company.
Oversee and manage the development of strategic plans for medical operations, including medical launch tactical plans, aligning operational activities with business objectives in a diversified portfolio.
Identify, develop, and implement process improvement initiatives to enhance operational efficiency and effectiveness within medical operations, with a specific focus on field medical excellence.
Lead and manage projects aimed at operational excellence, from planning and execution to monitoring and evaluation.
Ensure compliance with regulatory standards and internal quality requirements, conducting regular audits and assessments.
Analyze operational data to identify trends, root causes, and opportunities for improvement. Develop and track key performance indicators (KPIs).
Design and ensure delivery of training programs at high standards to build operational excellence capabilities within the team.
Work closely with cross-functional teams, including medical affairs, clinical operations, regulatory affairs, commercial and marketing, and quality assurance, to drive alignment and achieve operational goals.
Lead change management efforts to ensure successful implementation of process improvements and operational initiatives.
Regularly assess industry best practices, internal needs, opportunities and challenges, and identify fit-for-purpose opportunities to adopt and enhance medical impact and create operational efficiencies.
Minimum Job Requirements
Qualifications
Bachelor's degree in a relevant field (e.g., Life Sciences, Pharmacy, Business Administration).
Advanced degree (MBA, MSc) or extensive high-level management training preferred.
Minimum of 8 -10 years (Director) or, minimum 10-12 years (Senior Director) of experience in medical operations, clinical operations, or a related field within the pharmaceutical or healthcare industry. Medical Affairs experience in a similar role highly preferred.
Strong knowledge of operational excellence methodologies (e.g., Lean, Six Sigma) preferred.
Prior US launch experience required.
Excellent project management and organizational skills.
Proficiency in data analysis and reporting tools.
Strong communication and interpersonal skills.
Ability to lead and influence cross-functional teams.
Knowledge of regulatory requirements and quality standards in the healthcare industry.
Competencies
Problem Solving : Strong analytical and critical thinking skills to address complex operational challenges.
Adaptability : Ability to thrive in a dynamic and fast-paced environment.
Innovation : Creativity in developing new approaches and solutions to improve operations.
Collaboration : Effective teamwork and partnership with diverse stakeholders.
Digital Proficiency : Ability to work with digital assistance and native approaches, supported by new technologies such as machine learning and AI.
Other Requirements
This position has significant decision-making authority.
Ability and willingness to travel approximately 20-30% of the year
Must live a commutable distance to our US Corporate Headquarters in NJ. Office presence required 50% per month, at least 2-3 days per week.
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