Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably.
Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions.
As a Vice President of Clinical Sciences, you will be responsible for :
• Providing high-level strategic leadership for Clinical Science supporting internal and external innovation and product lifecycle management.
• Partner and interact with senior stakeholders in the business (Marketing, R&D, RA, MA, etc.) to achieve product development and commercialization objectives for the three Siemens Healthineers Diagnostics Business Line - Central Lab Solutions, Specialty Lab Solutions and Point of Care.
• This position also serves as consultant to Product Development (PD) and Business Development groups to ensure that all relevant medical needs and requirements are addressed during the pre-commercial PD phase.
• Scientific Support: clinical deliverables related to intended use
• Clinical Operations: clinical product development deliverables as well as successful execution of clinical trials under adherence to GCP and other regulatory requirements
• Validation/Clinical Trials: internal clinical laboratory according to GCP
• Specimen acquisition: procurement of human samples for product development and manufacturing (including Body Fluid Donor Program).
This position may suit you best if you are familiar with what is below, and would like to do develop your career with Healthineers
Active engagement and/or role in related industry associations (AACC, Advamed, etc.)
In-depth understanding of in vitro diagnostics (IVD) product development process, esp. for assays
Knowledge of Software as a Medical Device (SaMD) products is a benefit.
Change agent and collaborative team player
Required skills to have for the success of this role
PhD or MSc in Health Sciences related degree (PhD strongly preferred)
15+ years industry experience including senior management positions in Assay Development, Quality Assurance, Regulatory
Must have extensive experience leading Clinical Affairs teams in IVD, life sciences or medical device industries is a must
Must have demonstrated success commercializing IVD products including immunoassay, molecular and POC through FDA, Health Canada, and the EU as well as ROW.
Proven ability to build strong relationships with regulatory authorities as well as Key Opinion Leaders (KOLs) in various fields related to support for product development and clinical study design.
Highly proficient with ISO 13485, MDSAP, IVDR and GCP requirements.
Cross functional leadership skills for interaction with internal executive team members, as well as with external KOLs, CROs and other 3rd parties.
Strong leadership, coaching, and mentoring skills
Able to organize, prioritize and execute to achieve company goals.
Excellent ability to capture complex scientific and technical topics and translate them to business stakeholders
Excellent interpersonal, written / verbal communication and presentation skills
25 % travel (domestically and international)
Who we are: We are a team of more than 71,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.
How we work: When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual's potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world's most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.
The pay range for this position is $250,000-300,000 U.S. dollars annually; however, base pay offered may vary depending on job-related knowledge, skills, and experience, as well as where the work will be performed. Siemens Healthineers offers a variety of health and wellness benefits including paid time off and holiday pay. Details regarding our benefits can be found here: https://benefitsatshs.com/index.html
This information is provided per the required state Equal Pay Act. Base pay information is based on market location. Applicants should apply via Siemens Healthineers external or internal careers site.
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