The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc.
Director, HJF Product & Device for Clinical Development
The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc., Bethesda, Maryland, us, 20811
Overview
Join the HJF Team! HJF is seeking a
Director, HJF Product and Device for Clinical Development Office
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. Also, integrate the Product and Device Development Office (PDDO) with existing HJF 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. Develop a pharmacovigilance capability as part of the PDDO. Serve as a Senior Research Physician providing support to clinical research protocols from funding proposal development to study implementation, with a focus on the Global Infectious Diseases portfolio of international observational and interventional clinical research and other affiliated programs. This position will be in support of Home Office elements including the Chief Medical Officer, Office of Regulatory Affairs and Research Compliance, Technology Transfer Office, as well as HJF programs groups interested in product 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.
Responsibilities 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. Participate in the development of funding proposals, design, implementation, analysis and publication of clinical research with an emphasis on Human Immunodeficiency Virus (HIV) and emerging infectious diseases within the Global Infectious Disease Portfolio. In this capacity, write and manage grant proposals to obtain funding from multiple funding sources. Assist in the strategy and coordination of preclinical studies where needed, conduct clinical research according to approved protocols as a Protocol Chair, Principal Investigator, Associate Investigator, Consultant or other designated role. Contribute to 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. Ensure the integrity of study data and health and welfare of study participants. Provide appropriate medical oversight and study-related clinical decision making including the identification, classification, management and reporting of adverse events. Coordinate scientific and laboratory input, output and analyses. Provide similar support to other Portfolios as required. Provide leadership and oversight for pharmacovigilance activities of HJF supported clinical studies and FDA communications to include regulatory meeting agendas and minutes, annual and safety reporting documents for the FDA and other regulatory agencies. Ensure materials 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. 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. 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.
Qualifications Education and Experience Medical Degree (MD) required. Minimum of 3-5 years experience required. Required Knowledge, Skills and Abilities Must have clinical research experience. Knowledge of federal and local regulations and policies pertinent to research involving human subjects, 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 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-$310,000. 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.
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Join the HJF Team! HJF is seeking a
Director, HJF Product and Device for Clinical Development Office
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. Also, integrate the Product and Device Development Office (PDDO) with existing HJF 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. Develop a pharmacovigilance capability as part of the PDDO. Serve as a Senior Research Physician providing support to clinical research protocols from funding proposal development to study implementation, with a focus on the Global Infectious Diseases portfolio of international observational and interventional clinical research and other affiliated programs. This position will be in support of Home Office elements including the Chief Medical Officer, Office of Regulatory Affairs and Research Compliance, Technology Transfer Office, as well as HJF programs groups interested in product 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.
Responsibilities 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. Participate in the development of funding proposals, design, implementation, analysis and publication of clinical research with an emphasis on Human Immunodeficiency Virus (HIV) and emerging infectious diseases within the Global Infectious Disease Portfolio. In this capacity, write and manage grant proposals to obtain funding from multiple funding sources. Assist in the strategy and coordination of preclinical studies where needed, conduct clinical research according to approved protocols as a Protocol Chair, Principal Investigator, Associate Investigator, Consultant or other designated role. Contribute to 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. Ensure the integrity of study data and health and welfare of study participants. Provide appropriate medical oversight and study-related clinical decision making including the identification, classification, management and reporting of adverse events. Coordinate scientific and laboratory input, output and analyses. Provide similar support to other Portfolios as required. Provide leadership and oversight for pharmacovigilance activities of HJF supported clinical studies and FDA communications to include regulatory meeting agendas and minutes, annual and safety reporting documents for the FDA and other regulatory agencies. Ensure materials 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. 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. 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.
Qualifications Education and Experience Medical Degree (MD) required. Minimum of 3-5 years experience required. Required Knowledge, Skills and Abilities Must have clinical research experience. Knowledge of federal and local regulations and policies pertinent to research involving human subjects, 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 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-$310,000. 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.
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