Sr. Program Manager - Medical Device

Company Description

Sirtex Medical is a global healthcare business with offices in Boston, Sydney, Germany, and Singapore, working to improve outcomes in people with cancer. Our current lead product is a targeted radiation therapy for liver cancer called SIR-Spheres® Y-90 resin microspheres. More than 100,000 doses have been supplied to treat patients with liver cancer at more than 1,300 medical centers in over 50 countries.  

At Sirtex, we’re transforming our industry through our leadership with interventional oncology and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. We offer stimulating careers and development, encourage innovation, and strive for excellence in everything we do. We will always foster a diverse and inclusive workplace, in which our global teams are united by an unwavering commitment to improve the quality and longevity of patients’ lives by providing innovative interventional oncology solutions.

Here, you will be a vital contributor to our inspiring and bold mission. 

Job Description

Position Summary

The Sr. Program Manager is responsible for the successful initiation, execution, and monitoring of any Sirtex cooperate programs including NPI, NPD, commercial launch, clinical, and post market surveillance. This role will be responsible for multiple cross-functional streams of work, identification, and resolution of program-level issues and the mitigation of risks where they pose a significant threat to success, always with a focus on delivering value to the business in a timely manner. The role requires an individual who has proven commercial product launch, clinical study and post market surveillance.

Authorities/Responsibilities:

• Responsible for planning and execution of commercial launch of a Sirtex product or acquired product via BD.
• Responsible for post market projects to ensure Quality, Safety, and compliance of Sirtex products through Quality management system, with a focus on Design Control and Post-Market processes.
• Responsible for monitoring key clinical studies and reporting to senior management and shareholders.
• Document and maintain archives for all product-related development activities such as plans, schedules, meeting minutes, management reviews, and departmental reviews.
• Coordinate activities between operational and commercial organizations from project initiation through launch.
• Maintains effective communication with senior management, providing awareness of critical issues and action plans for resolution of issues.
• This position is responsible for team integration on a program, overall project management, and for evaluation and reporting project status to senior management.
• Analyzes the impact of changes in existing projects or addition of new projects and identifies strategies (resources allocation/project sequencing) for accomplishing all desired projects----identifies project interrelationships that affect priority and resources allocation decisions.
• Ability to anticipate areas of difficulty/potential unknown risks, contribute towards creative solutions and moves to action quickly.

Qualifications

• Bachelor's degree in health sciences, health administration, biomedical, engineering, or related field required.
• >5 years’ experience of commercial product launch as a project lead or program manager in medical device or pharmaceutical industry.
• >3 years’ experience of clinical study program management.
• >3 years’ experience of post market program management.
• >5 years of proven experience in program management with an emphasis on project planning, scope/schedule control, problem solving, risk mitigation, communications.
• Project Manager Professional (PMP) certificate preferred.
• Demonstrated project management, consulting, process flow development and facilitation skills.
• Ability to successfully perform in a matrix accountability structure, reporting the progress of deliverables and project updates to senior leadership team.
• Proficient communications skill (oral, written and presentation) with the ability to communicate effectively through all levels of the organization.
• Strong computer skills including knowledge of MS Project, Excel, Word, PowerPoint, and Outlook.
• Excellent engagement, facilitation, and interpersonal skills, with the ability to unite those with various perspectives towards a shared vision. 
• Excellent organizational skills with high attention to detail with the ability to effectively multi-task in a fast-passed environment. 
• Ability to handle multiple project assignments, meeting strict deadlines.
• Mandarin speaking is a plus.
• Position may require some travel (up to 25%).

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