Senior Director, Clinical Product and Device Development

Senior Director, Clinical Product and Device Development

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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

Required Knowledge, Skills And Abilities

Licenses and Certifications

Work Environment

Compensation

Benefits

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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