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.

• 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 Florham Park, NJ. Office presence required 50% per month, at least 2-3 days per week.

Essential Physical and Mental Requirements

• Ability to articulate clearly and conduct verbal presentations with large and small audiences.
• Ability to travel via automobile and/or airplane.
• Ability to view video display terminal images < 18” away from face for extended period of time – up to four (4) hours at a time.
• Ability to operate a computer keyboard and telephone.
• Ability to sit for extended periods of time – up to four (4) hours at a time.
• Ability to lift, tug, pull up to fifteen (15) pounds.

To be considered for this position, you must apply and meet the requirements of this opportunity.

We look forward to reviewing your resume & qualifications.

Disclaimer

The job description is not designed to cover or contain a comprehensive listing of requirements, duties or responsibilities that are required of the employee. Other requirements, duties and responsibilities may change or be assigned at any time with or without notice. 

You acknowledge and agree that information described herein may be disclosed to applicable regulatory authorities, alliance partners and/or third party service providers as necessary for Shionogi to fulfil its obligations under applicable laws, including but not limited to compliance with regulatory inspections and/or audits.

Shionogi Inc. is an equal opportunity/affirmative action employer.
All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity, marital status, national origin, age, ancestry, citizenship, disability, genetic information, status as a disabled veteran, a recently separated veteran, Active Duty Wartime or Campaign Badge Veterans, and Armed Forces Service Medal Veterans, or any other characteristic protected by applicable law.
It is the policy of Shionogi Inc. to undertake affirmative action in compliance with all federal, state, and local requirements to recruit a diverse pool of applicants and to ensure that our employment practices are, in fact, non-discriminatory.