Product Management Support - Blood Subject Matter Expert Support

Job Description

Daily Responsibilities:

Shape the future of military medicine by serving as a trusted advisor on some of the Department of Defense’s most critical blood, transfusion, and combat casualty care programs. In this role, you will collaborate with leading scientists, clinicians, acquisition professionals, and industry partners to guide the development and delivery of lifesaving medical products for Warfighters. This is a unique opportunity to apply deep technical expertise while influencing high-visibility programs from concept through fielding and operational use.

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• Serve as an advisor and subject matter expert (SME) in Blood and Blood Products, Blood Research, Blood Product Operations, and other Combat Casualty Care Products or Devices to include traumatic hemorrhage, hematology, and transfusion medicine.
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• Provide proactive, top level technical expertise to the PMO and support the advanced development requirements for medical products, requiring the ability to manage numerous efforts and effectively prioritize and multi-task initiatives and projects.
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• Independently perform activities consistent with established organizational practices, precedents, policies and strategic objectives set forth by PMO leadership and freely communicate the status of those activities to assigned PdMs and PMO Leadership.
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• Work closely with the advanced development team to facilitate development design sessions of major product initiatives and associated activities throughout the entire lifecycle of the assigned products.
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• Maintain current knowledge of relevant technology and industry developments through independent market research, stakeholder engagement, and continuing education.
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• Act as integral member of Integrated Product Teams (IPT), preparing for, attending, and contributing to internal and external meetings such as working groups, committees and subcommittees, one-on-one or small group touchpoints, site visits, program briefings, investigator meetings, and partner update meetings.
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• Communicate with personnel at various echelons using effective interpersonal and communication skills, both written and oral.
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• Assess and monitor the risks and stakeholder positions/opinions associated with development of blood and blood products and communicate findings to the PdM and/or PMO Leadership.
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• Support PdMs with program document preparation throughout the DoD Acquisition Lifecycle to include Acquisition Strategies, Acquisition Decision Memoranda, Acquisition Program Baselines, Analysis of Alternatives, Requirements Documents, Concepts of Operations/Use/Employment, Life Cycle Sustainment Plans, Life Cycle Cost Estimates, Requests for Information/Proposal, Systems Engineering Plans, and Test and Evaluation Master Plans.
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• Provide expertise and assist PdMs with writing program documentation such as information/position/white papers, RFI responses, memoranda for program record, publications, technical guides, executive summaries and situational reports, data summaries, market research reports, risk assessments, program-relevant plans and protocols, decision logs, and briefings.
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• Review program documentation for technical correctness and give expert analysis on highly specialized tasks including design and evaluation of non-clinical studies; development and execution of clinical trial designs; review of non-clinical study reports; inputs into the chemistry, manufacturing and controls of biologics, drugs and devices; development of plans for testing, fielding, delivery, and/or training on assigned products; and development and implementation of policies, regulations, or other documentation that governs how blood products and combat casualty care-related products will be acquired, used, and tracked.
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• Proactively review clinical protocols and associated clinical trial documents, various regulatory applications and communications, and Food and Drug Administration (FDA) recommendations.
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Degree: Bachelor’s degree in a relevant area; advanced degree preferred

Required Experience:

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• Minimum 10 years of relevant professional experience in blood and blood-product development or closely related areas
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• Demonstrated expertise in blood and blood products, transfusion medicine, traumatic hemorrhage, hematology, blood research, or combat casualty care medical products.
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• Experience supporting the advanced development and lifecycle management of FDA-regulated biologics, drugs, medical devices, or blood products, including clinical and nonclinical studies, regulatory submissions, and chemistry, manufacturing, and controls activities.
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• Knowledge of the DoD acquisition lifecycle and experience developing or reviewing acquisition, requirements, test and evaluation, sustainment, risk, and program-management documentation.
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• Ability to independently analyze complex scientific, clinical, regulatory, and programmatic information and provide authoritative recommendations to product managers, Integrated Product Teams, and senior leadership.
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• Strong written and oral communication skills, including experience preparing technical analyses, white papers, executive briefings, regulatory documentation, risk assessments, and decision-support materials.
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• Ability to manage multiple concurrent product-development efforts, assess technical and stakeholder risks, and collaborate effectively with clinical, scientific, regulatory, acquisition, and industry stakeholders.
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• Ability to travel up to 30 percent and meet the solicitation’s personnel-security and U.S. citizenship requirements.
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Required Clearance:

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• U.S. citizenship required
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