Director, HJF Product & Device Development Office - Pre-Clinical

Join the HJF Team!

HJF is seeking a Director, HJF Product and Device Development Office - Pre-Clinical to assess assess HJF drug, biologic, or device 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. This role will develop staff, processes and policies to frame the management of product development. Integrate the Product and Device Development Office (PDDO) with existing Home Office (HO) elements to include the Office of Regulatory Affairs and Research Compliance, Technology Transfer Office as well as programmatic groups which act as investigators for the products of interest.

This position will be in support of Home Office (HO elements) to include the Chief Medical, the Office of Regulatory Affairs and Research Compliance, Technology Transfer Office and programs interested in product/device development.

The Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF) is a nonprofit organization dedicated to advancing military medicine. We serve military, medical, academic and government clients by administering, managing and supporting preeminent scientific programs that benefit members of the armed forces and civilians alike. Since its founding in 1983, HJF has served as a vital link between the military medical community and its federal and private partners. HJF's support and administrative capabilities allow military medical researchers and clinicians to maintain their scientific focus and accomplish their research goals.

• Develop and maintain a catalog of HJF efforts in product or device development subject to FDA and other applicable regulatory oversight. Characterize risks, opportunities and requirements for HJF support to include assumption of Investigational New Drug/Investigational Device Exemption (IND/IDE) or other key leadership role and communicate this to HJF executive leadership for action. Assist business development, contracting and other groups in assessing risks associated with HJF roles in product development and mitigation of recognized risks whether HJF is sponsor or in a support role.
• Develop product/device regulatory strategies and lead the development of pre-IND and IND documents for FDA submission to Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER) and if applicable other submissions such as 510(k) Premarket Notifications, Investigational Device Exemptions (IDEs) and/or Premarket Approval applications (PMAs) to Center for Devices and Radiological Health (CDRH).
• Provide leadership and oversight for FDA communications to include regulatory meeting agendas and minutes, annual and safety reporting documents for the FDA and other regulatory agencies and ensure they are delivered to the relevant agencies in the format required in the required time frame. Participate in FDA meetings for IND/IDEs.
• Collaborate with cross-functional teams in Home Office and the programs distributed among the HJF portfolios to integrate regulatory requirements and strategies. Provide tailored regulator roadmaps to Principal Investigators (PIs) for preclinical studies leading to IDE and IND submission. Participate in protocol or project team meetings as the regulatory representative for HJF when the IND or IDE sponsor and in selected regulated studies as assigned. Support business development, contracting/sub-award and tech transfer offices proposal development, writing and strategic planning.
• May perform other duties and responsibilities as assigned or directed by the supervisor. This may include attendance of and participation in required training for role.

Supervisory Responsibilities

• Direct Supervisor: Direct authority to make decisions on the following: employee hiring, disciplinary action, starting salaries and merit increases; conduct employee performance evaluations and directs work activities.

Education and Experience

• Master's Degree required. MD or PhD preferred.
• Minimum of 3-5 years experience required.

Required Knowledge, Skills and Abilities

• Experience with the management of device and product development in a clinical space.
• Knowledge of federal and local regulations and policies pertinent to research involving human subject, laboratory animals and recombinant DNA.
• Knowledge and experience with Common Technical Documents (CTC), TMFs, INDs, IDEs.
• Excellent communication and writing, interpersonal and organizational skills.
• Self-starter and be able to work independently.
• Ability to multi-task.
• Ability to utilize computer applications packages such as MS Word, Excel, PowerPoint, Access, FileMaker, Adobe Acrobat Pro, cloud-based eRegulatory platforms and E-mail.

Work Environment

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

Compensation

• The annual salary range for this position is $173,400-$285,000. Actual salary will be determined based on experience, education, etc.

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.

Some HJF employees are required to be fully vaccinated against COVID-19. Proof of vaccination or an approved religious or medical accommodation will be required.

Employment with HJF is contingent upon successful completion of a background check, which may include, but is not limited to, contacting your professional references, verification of previous employment, education and credentials, a criminal background check, and a department of motor vehicle (DMV) check if applicable.

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. 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. 41 CFR 60-1.35(c)

Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer.