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Senior Director, Clinical Product and Device Development
Senior Director, Clinical Product and Device DevelopmentThe Henry M. Jackson Foundation for the Advancement of Military Medicine • Bethesda, MD, United States
Senior Director, Clinical Product and Device Development

Senior Director, Clinical Product and Device Development

The Henry M. Jackson Foundation for the Advancement of Military Medicine • Bethesda, MD, United States
[job_card.30_days_ago]
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  • [job_card.full_time]
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Senior Director, Clinical Product and Device Development

Join to apply for the Senior Director, Clinical Product and Device Development role at The Henry M. Jackson Foundation for the Advancement of Military Medicine

Job Description

HJF is seeking a Senior Director, Clinical Product and Device Development to assess product development opportunities, risks, and support requirements to ensure successful advancement and full compliance with Food and Drug Administration (FDA) and other applicable regulatory requirements. The incumbent will serve as a senior clinical researcher providing support to clinical research protocols - from funding proposal development to study implementation - with a focus on clinical research.

The incumbent demonstrates knowledge, skills, and experience in areas such as, but not limited to, clinical research design and implementation; pharmacovigilance; FDA regulatory pathways and options, including FDA regulatory clinical trial implementation; internal and external communication and collaboration; and proposal development and compliance with different regulatory authorities.

Responsibilities

  • Provide subject matter expert (SME) support to FDA-regulated product development efforts.
  • Develop and maintain a catalog of HJF efforts in supporting product or device development subject to FDA and other applicable regulatory oversight.
  • Provide leadership and oversight for pharmacovigilance activities of HJF-supported clinical studies and associated FDA communications.
  • Collaborate with cross-functional teams within the Bethesda Home Office and with the programs to integrate regulatory requirements and strategies.
  • May perform other duties and responsibilities as assigned or directed by the supervisor.

Qualifications

  • MD, DO, PhD or PharmD required.
  • Minimum of 6-8 years experience required.

    • Required Knowledge, Skills And Abilities

  • Thorough knowledge of clinical research, including clinical trial management, and the procedures and techniques necessary for performing research tasks.
  • Knowledge of medical science and the development of clinical research programs.
  • Experienced in the design of clinical trials research.
  • Knowledge of federal and local regulations and policies pertinent to research involving human subject, laboratory animals and recombinant DNA.

    • Licenses and Certifications

  • If a physician, licensure to practice medicine within the continental United States and board-certified or board-eligible in a medical discipline.
  • Regulatory Affairs Certification (RAC) is preferred.

    • Work Environment

  • This position will take place primarily in an office setting.

    • Compensation

  • The annual salary range for this position is $300,000-$350,000.

    • Benefits

  • HJF offers a comprehensive suite of benefits focused on your health and well-being, from medical, dental, and vision coverage to health savings and retirement plans, and more.

    • Employment with HJF is contingent upon successful completion of a background check.

    Equal Opportunity Employer / Protected Veterans / Individuals With Disabilities

    The contractor 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.

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