Siemens Careers

Sr Director Clinical Affairs

Tarrytown, New York
Quality Management

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English (US)

Job Description

Division: Siemens Healthineers
Business Unit: Laboratory Diagnostics
Requisition Number: 236045
Primary Location: United States-New York-Tarrytown
Assignment Category: Full-time regular
Experience Level: Senior level
Education Required Level: Master's Degree
Travel Required: 25%

Division Description:

At Siemens Healthineers, we are passionate about enabling healthcare professionals to deliver high quality patient care, and to do so affordably.  A leading global healthcare company, Siemens Healthineers continues to strengthen our portfolio of medical imaging and laboratory diagnostics, while adding new offerings such as managed services, consulting, and healthcare IT services – as well as further technologies in the growing market for therapeutic and molecular diagnostics.
 
Siemens Healthineers develops innovations that support better patient outcomes with greater efficiencies, giving providers the confidence they need to meet the clinical, operational and financial challenges of a changing healthcare landscape.
 
For more information, please visit: http://www.usa.siemens.com/healthineers


Job Description:


 
Senior Director, Clinical Affairs
 
The Sr. Director Clinical Affairs oversees all clinical strategy and operations supporting product development and commercialization objectives of the Siemens Healthineers, Laboratory Diagnostics Immunoassay and Clinical Chemistry product portfolios. This includes overall responsibility for design and successful execution of clinical studies under adherence to GCP and other regulatory requirements. The position will manage a multisite team of currently five senior managers with their teams of clinical project managers and research associates (CRA). The Sr. Director Clinical Affairs will interact with senior stakeholders in the business (Marketing, R&D, RA, MA, etc) and reports to the Vice President Validation / Clinical Affairs.
 
Responsibilities
 
The Sr. Director Clinical Affairs sets the strategy and goals for the team based on the defined business and portfolio objectives. On a more tactical level, this includes:
  • Leadership and direction on clinical design strategy
  • Accountability for the Clinical Affairs project and cost center budgets (3-5 year plan)
  • Prioritization of staffing and assignment of projects
  • Management of process for screening, qualifying, selecting and contracting of clinical study related vendors and HCOs
  • Accountability for timely communication of project status to senior management
  • Support of FDA communication as well as management of Clinical Research Organizations and Key Opinion Leaders
  • Support other countries’ regulatory and clinical affairs team (e.g. China RA/CA) with clinical design, team structure and regulatory changes
  • Analysis of effectiveness of clinical processes and their alignment with rules and regulations in key global markets
  • Continuous assessment of functional structure against business and regulatory needs as well as initiation of organizational adjustments, as needed
  • Accountability for internal and external audits
 
Required Knowledge/Skills, Education, and Experience
 
  • PhD or MSc in Health sciences related degree
  • 7-15 years of senior clinical management position in IVD, life sciences or medical device industry, or CRO, or academic/hospital clinical research environment; higher level degree can be substituted with more years of managerial experience
  • Proven track record in execution of successful clinical trials
  • Strong leadership, coaching, and mentoring skills
  • Ability to multitask and changing priorities “on the fly”
  • Excellent interpersonal, written / verbal communication and presentation skills
  • 25 % travel (domestically and international)
  • High level computer skills required (e.g. Word, Excel, PowerPoint)
 
Preferred Knowledge/Skills, Education, and Experience
 
  • Knowledge of electronic data capture systems and web-based clinical trial management tools
  • In-depth understanding of common IVD product development processes / requirements
  • Change agent and collaborative team player


Equal Employment Opportunity Statement
Siemens is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, protected veteran or military status, and other categories protected by federal, state or local law.

EEO is the Law
Applicants and employees are protected under Federal law from discrimination. To learn more, Click here.

Pay Transparency Non-Discrimination Provision
Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, Click here.



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