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Director Clinical Research

Location United States - California - Santa Clara Category Medical and Clinical Affairs
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JOB DESCRIPTION

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

Director, Clinical Research

Our business purpose is to lead and shape the treatment of patients with structural heart disease via driving innovation, prioritizing clinical research, and championing product and procedural excellence.

What You’ll Work On

The Director of Clinical Programs will lead the portfolio of clinical trials including clinical trial strategy development and execution to support evidence generation for Abbott’s transcatheter mitral and tricuspid interventions (TMTI) portfolio. The individual will interact with multiple internal cross-functional teams, including R&D, medical affairs, regulatory affairs and finance to set the overall direction for the TMTI portfolio, and create/manage budgets, priorities and timelines. The individual will also lead interactions with key opinion leaders, clinical trial investigators, regulatory agencies, and reimbursement agencies to ensure successful execution of clinical strategies to meet corporate goals.   

This candidate will lead a cross functional team comprising clinical scientists, field clinical specialists, project management, biostatistics, medical affairs, data management, and other clinical study personnel towards clinical evidence generation, clinical trial strategy development, oversight of trial execution, and generation of clinical study reports/ scientific publications from data generated from pre- and post-market clinical trials under Abbott corporate policies and standard operating procedures. 

Core Job Responsibilities: 

  • Oversee the development of clinical evidence strategies to address worldwide regulatory and reimbursement needs to accomplish business objectives
  • Be responsible and accountable for planning and executing the global clinical evidence generation plans
  • Set budgets and timelines in alignment with business objectives, and manage clinical trial portfolio in accordance with these
  • Oversee the design of clinical trials and studies in collaboration with internal stake holders including clinical project management, clinical operations, clinical science, biostatistics, data management, regulatory affairs, medical affairs as well as external stake holders including steering committees, and national principal investigators (if applicable) and ensure that the study is executed within budget and timelines
  • Serve as the primary clinical liaison to regulatory bodies (such as FDA, BSI, etc) and ensure that the clinical strategy is in alignment with regulatory and product development strategy
  • Collaborate across functions to establish study guardrails and ensure execution of clinical trials per established guardrails
  • Oversee the generation of study-related documents including, but not limited to, clinical study rationale documents, clinical study protocols, case report forms, clinical study reports, and informed consent forms
  • Oversee the development of the scientific podium and publication strategy in collaboration with cross-functional teams
  • Develop and execute on the scientific podium and publication strategy in close collaboration with cross-functional teams, and lead the execution of the publication strategy
  • Effectively communicate information through the planning and execution of meetings and presentations and present recommendations to senior staff
  • Evaluate changes in regulatory, risk management, quality systems and/or clinical environment in relation to clinical evidence generation strategies
  • Lead and motivate functional area teams to meet key project deliverables and timelines by developing effective technical strategies and collaborating with functional management to coordinate tactical execution by sub team members and functional organizations
  • Oversee data analyses with input from internal and external functional experts incorporating underlying assumptions and risks and benefits to drive rigorous decision-making
  • Develop, mentor, and guide clinical scientists and oversee their work products (clinical trial protocols, informed consents, responses to regulatory questions, investigator brochures, clinical reports)
  • Foster creative thinking, innovation, knowledge sharing and reasoned risk-taking 

Required Qualifications

  • Masters or PhD degree in medical or scientific field, or equivalent combination of education and experience is required.
  • PhD in the cardiovascular field with 10+ years of relevant experience is preferred.
  • IDE, risk management, and/or clinical evaluation experience required. 
  • Management experience or experience leading organizations in matrixed setting desirable. 
  • Global experience preferred. 

 APPLY NOW:

Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:  www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal



The base pay for this position is $193,300.00 – $386,700.00. In specific locations, the pay range may vary from the range posted.

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Job Id 31113579 Location United States - California - Santa Clara Medical surveillance Not Applicable Division SH Structural Heart Travel Not specified Additional Location Significant work activities Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

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