Senior Director, Clinical Product and Device Development

Join the HJF Team!

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 will provide oversight for the Office of Regulatory Affairs and Research Compliance.

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. The incumbent will provide expert advice to HJF executives regarding clinical development risk and mitigation steps. The incumbent will assess potential clinical research opportunities for HJF prioritization; ensure compliance for clinical research initiatives; and mitigate risks to achieve project goals. The incumbent may participate in some clinical research activities as needed to achieve these goals.

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.

Responsibilities

• Provide subject matter expert (SME) support to FDA-regulated product development efforts. Consult in developing funding proposals, as well as in the design, implementation, analysis, and publication of clinical trials research. Participate in development of clinical trials agreements, when appropriate. Support clients in FDA-regulated medical product development strategies. In this capacity, assist in the strategy and coordination of preclinical studies where needed, either prior to or following FDA consultation; advise on the creation, composition, maintenance, and execution of clinical research protocols and supporting documents, including study-related budgets and status reports; maintain ethical and regulatory compliance, ensuring the integrity of study data and health and welfare of study participants; provide appropriate medical oversight, when indicated, and support for study-related clinical decision-making, including the identification, classification, management, and reporting of adverse events; and coordinate scientific and laboratory input, output, and analyses. Oversee a robust Clinical Trials Monitoring capability with accurate and timely reporting and issue adjudication.
• Develop and maintain a catalog of HJF efforts in supporting product or device development subject to FDA and other applicable regulatory oversight. Characterize risks, opportunities and requirements for HJF support to include assumption of sponsorship of investigational new drug applications (INDs), investigational device exemptions (IDEs), combination devices, and/or or other key leadership roles in FDA regulated product development, then communicate this to HJF executives for action. Assist business development, contracting, and other groups in assessing risks associated with HJF assuming roles in product development and clinical research, then propose risk mitigation strategies, regardless whether HJF is in a sponsor or support role.
• Provide leadership and oversight for pharmacovigilance activities of HJF-supported clinical studies and associated FDA communications including preparing regulatory meeting agendas and documenting and obtaining FDA validation of minutes. Support preparation of annual and safety reporting documents for the FDA and other regulatory agencies. Ensure these communications 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 within the Bethesda Home Office and with the programs to integrate regulatory requirements and strategies. As HJF's regulatory representative, participate in protocol or project team meetings whenever HJF is the IND or IDE sponsor, as well as for selected regulated studies as assigned. Support business development, contracting/sub-award and tech transfer offices proposal development, writing and strategic planning. Support the Office of Regulatory Affairs and Compliance.
• 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

• 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.
• Knowledge of FDA requirements related to IND and IDE sponsorship and knowledge of National Institutes of Health (NIH) extramural funded program requirements, as related to clinical studies.
• Experienced in medical review of adverse clinical trial events.
• Knowledge and experience with Common Technical Documents (CTC), TMFs, INDs, IDEs.
• Excellent interpersonal, oral and written communication skills.
• Strong organization skills. Self-starter, capable of independent multi-tasking.
• Ability to effectively use common computer applications such as MS Word, Excel, PowerPoint, Access, FileMaker, Adobe Acrobat Pro, cloud-based eRegulatory platforms and e-mail.

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. 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.

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

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.