Director, Global Clinical Evidence in Fremont, CA bei Stryker Corporation

Datum der Veröffentlichung: 9/27/2019

Stellenauszug

Stellenbeschreibung

WHAT YOU WILL DO:

If you are someone who is passionate about the back end generation of evidence, and wants to get on the podium globally to move the needle on stroke care, this is a great role for you! You will lead an awesome team of writers, biostatisticians, data managers and medical communicators/writers. You will provides direction on the overall clinical evidence generation within the global Neurovascular (NV) business. Responsible for creating and maintaining all processes and managing all clinical individuals responsible for generation of clinical study reports, regulatory-required routine reports, publications, podium clinical presentations, MDR-specific deliverables, CER/CES, etc.. Primary focus of role is to maximize the leverage of clinical data generated by Stryker-sponsored research, Investigator Initiated research, Collaborative Studies, literature and Stryker-initiated Clinical Science (small studies, metanalyses, papers, CES/CER, etc.) Secondary focus of role is on establishing/improving major Clinical processes that enable the generation of high-quality data in the most efficient manner as possible. Underlying goal is to obtain and maintain a clinical leadership position in the global NV community. Responsible for all clinical evidence/output for a Clinical spend in the range of $25- 30M/year.

You will provide direction on all Business Process Improvement (BPI) for global Clinical Evidence generation across all of the Division. BPI areas of focus would include:

  • Biostatistics and Data Management organization related to trial database generation, management, report generation, programming, medical coding to name a few. Manages the global clinical study portfolio for all SNV that includes financial responsibility for $25M annual spend.
  • CER/CES generation for MDR, NMPA and other global regulators requiring similar types of Clinical evaluation and/or summary reports.
  • All processes that lead to or rely on Medical Writing. This can include processes that relate to the generation of Clinical Study reports (SSR, IIR, Collaborative Studies, etc.) CER/CES, regulatory-required annual reports, Summary of Safety & Clinical Performance (MDR), Periodic Safety Update Reports MDR), etc.
  • All reports needed for secondary regulatory approvals beyond US, Japan, China and Europe to allow for regional pre-market approvals.
  • Management of all electronic systems, tools, databases, templates utilized for Clinical Operations, Biostats/Data management/Medical Affairs, etc.
  • All processes related to the presentation and/or publication of NV-related clinical information and as well general overall marketing communications.
  • Manages the Medical Writing group focusing on research supporting past, current and future trials; ensure literature review, ad-hoc analysis, meta analyses, etc. are conducted robustly yet efficiently.
  • Establishes clinical policies and interprets, executes, and recommends modifications.
  • Develops and implements Clinical organizational structure and supervisory relationships with direction and support from division Global Customer Excellence, Global Commercial Excellence and Clinical Affairs senior leadership.
  • Ensures strategic alliances with physicians, key opinion leaders, third-party monitors, core laboratories, CROs, consultants, etc. as appropriate to ensure safe, compliant and successful clinical trial conduct. • Works with external committees such as Medical Advisory Boards, Steering Committees, Publication Committees, Data Safety Monitoring Boards, Clinical Events Committees and others regarding trial related issues and opportunities.
  • Responsible for development of realistic clinical department budgets, schedules, and performance standards and directing the subfunctions for which responsible in accordance with these parameters.

WHAT YOU WILL NEED:

  • 15+ years Clinical Sciences and/or Business Program Management experience in the medical industry (device, pharmaceutical, biotechnology), including at least 5 years in a managerial capacity managing clinical programs and clinical professionals/Program Managers in a cross functional product development setting. Business Process Improvement (BPI) experience strongly preferred.
  • Degree in science/health related field (e.g., Biology, Nursing, Biomedical or Veterinary Sciences) required.
  • Degree in Business, MBA, Program Management or equivalent preferred

WHO WE WANT:

  • Sets direction. An innovator who defines ways to create value and deliver on Stryker’s mission and strategic imperatives.
  • Builds organizational capability. A strategic executive who continuously breaks down barriers, identifying new and more effective ways to accomplish tasks and goals.
  • Inspires others. A genuine, relationship-focused leader who connects, collaborates and fosters an inclusive environment of enthusiasm, trust and pride. He/she makes others want to follow, building momentum for action and positively influencing outcomes.
  • Champions talent development. A manager who focuses on maximizing the ability, potential and contributions of themselves and others. Fosters an environment where people can excel through developing, coaching and rewarding performance.
  • Delivers results. A driven player/coach who sets high goals for personal achievement and organizational success. He/she measures success against the best internal and external

Work From Home: No

Travel Percentage: Up to 25%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

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