23 days old

Watson Health Clinical Affairs Director

Multiple Cities, Multiple
  • Job Code

At IBM, work is more than a job - it's a calling: To build. To design. To code. To consult. To think along with clients and sell. To make markets. To invent. To collaborate. Not just to do something better, but to attempt things you've never thought possible. To lead in this new era of technology and solve some of the world's most challenging problems.

Your Role and Responsibilities
This role will be in our Hartland WI or Cambridge, MA site or Remote.

As a member of the Watson Health RAQA Organization you will provide clinical study leadership, strategic guidance and support for new and existing products. This role will be a dual role to design and execute clinical research programs to enable successful completion to clinical endpoints as well as supporting the regulatory registration of medical devices requiring clinical data and evidence for the domestic and international market.

The individual will be involved in the design, conduct, data management, and interpretation and reporting of clinical trials. This role will require coordinated development of clinical study strategies with Design teams and Offering Management. This individual must ensure that all clinical studies operate to the highest ethical and safety standards and in compliance with company, GCP and regulatory requirements. Job duties:
  • Leads the preparation of study documentation such as clinical plans, protocols, amendments, case report forms, investigator's brochures, study agreements and study reports
  • Contributes to the development of internal standard operating procedures and work instructions
  • Manages and ensures accuracy of regulatory notices and submissions (e.g. clinicaltrials.gov)
  • Investigational plans, Investigators manual and study reports.
  • Collects and processes regulatory documents and correspondence.
  • Manages and ensures accuracy for MV studies on clinicaltrials.gov
  • Coordinates other responsibilities for the Clinical Research Department with other functions.

Essential Job Duties
  • Develop clinical study designs and reports for clinical studies
  • Review and approve clinical study protocols and other documentation in support of clinical studies
  • Manage US and international regulatory submissions for the conduct of clinical studies and the approval/clearance of new products.
  • Manage CRO and/or other outside clinical study vendors.
  • Manage study timelines and budgets.
  • Drive clinical study communication to cross-functional teams.
  • Support data analysis and interpretation of clinical information.
  • Manage the process to compile and summarize post market clinical information to support regulatory documentation.
  • Support other clinical activities within the department as needed, including tasks in support of IBM-sponsored clinical studies.
  • Support staff to submit regulatory applications, as well as internal regulatory file documentation to achieve market clearances in US, Canada, EU, Australia, Japan and Brazil at a minimum.
  • Initiates product holds, as needed, where market authorizations have not been achieved
  • Acts as a core team member on development teams, providing clinical affairs feedback and guidance throughout the product development cycle.
  • Reviews and signs-off on product/manufacturing changes for compliance with applicable regulations and guidances in US, Canada, EU, Brazil, Japan and Australia at a minimum.
  • Collaborates with regional business partners to support international product registrations.
  • Assists with the development of regulatory department policy and procedure implementation.
  • Reviews device labeling and promotional materials for compliance with global submissions and applicable regulations; analyzes appropriate changes in accordance with US, Canada, EU, Brazil, Japan and Australia regulations at a minimum
  • Performs all duties and responsibilities as required by the Quality Management System Policies and Procedures
  • Assists with activities related to the corrective and preventative action (CAPA) process.
  • Participates in FDA, notified body, and other regulatory inspections.
  • Build quality into all aspects of their work by maintaining compliance to all quality requirements

Required Technical and Professional Expertise
  • Must be experienced in the medical device quality system regulations and international regulatory requirements for medical devices
  • Specific experience with clinical study design and software medical devices desired
  • Bachelors degree in a scientific or health discipline required; advanced degree preferred
  • Minimum of 15 years in the medical industry in Clinical Affairs, Clinical and Regulatory
  • Proficient in Good Clinical Practices requirements for US and EU
  • Proficient in preparing various types of regulatory submissions including 510(k), EU Technical Files, Australia technical files.
  • Experience with Health Canada Medical Device Licenses and US FDA PMA experience preferred
  • Working knowledge of FDA, EU, Japan, Australia, Brazil and Canada as well as other international regulations
  • General understanding of product development process and design control

Preferred Technical and Professional Expertise
  • n/a

About Business Unit
IBM Watson Health is pioneering a new partnership between humanity and technology with the goal of transforming global health and revolutionizing many aspects of the medical and pharmaceutical industries, as well as government sectors. We aspire to improve lives and give hope by delivering innovation to address the worlds most pressing health challenges through data and artificial intelligence insights.

Your Life @ IBM
What matters to you when youre looking for your next career challenge?

Maybe you want to get involved in work that really changes the world. What about somewhere with incredible and diverse career and development opportunities where you can truly discover your passion? Are you looking for a culture of openness, collaboration and trust where everyone has a voice? What about all of these? If so, then IBM could be your next career challenge. Join us, not to do something better, but to attempt things you never thought possible.

Impact. Inclusion. Infinite Experiences. Do your best work ever.

About IBM
IBMs greatest invention is the IBMer. We believe that progress is made through progressive thinking, progressive leadership, progressive policy and progressive action. IBMers believe that the application of intelligence, reason and science can improve business, society and the human condition. Restlessly reinventing since 1911, we are the largest technology and consulting employer in the world, with more than 380,000 IBMers serving clients in 170 countries.

Location Statement
US Citizenship required.

Being You @ IBM
IBM is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. IBM is also committed to compliance with all fair employment practices regarding citizenship and immigration status.



  • Computers Software and Hardware
Posted: 2020-01-02 Expires: 2020-02-01

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Multiple Cities, Multiple

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