Medical Advisor

Company Description

BryceTech has partnered with technology and R&D clients to deliver mission and business success since 2017. Bryce combines core competencies in analytics and engineering with domain expertise. Our teams help government agencies, Fortune 500 firms, and investors manage complex programs, develop IT tools, and forecast critical outcomes. We offer clients proprietary, research-based models that enable evidence-based decision-making. Bryce cultivates a culture of engagement and partnership with our clients. BryceTech is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran

Job Description

We are seeking a Medical Advisor to provide expertise in the areas of devices, diagnostics, vaccine technology, therapeutics (e.g., drugs, immunotherapy, etc.) drug treatment therapies, and entomology solutions for infectious diseases of military relevance; and/or other medical countermeasures, and/or regenerative medicine; and/or blood and blood products/components and other combat casualty care products or devices; and/or post-traumatic stress disorder and traumatic brain injury.

• Provide clinical management expertise for both DoD-sponsored and non-DoD-sponsored clinical research activities. Activities include but are not limited to:  serving as a SME involved in the initial planning and development of the contract management plan; planning, designing, coordination, management, and conduct of clinical trial research, to include but not limited to protocols; assist in the writing and preparation of clinical protocols and other clinical trial documents; serve as a key member of IPT
• Provide expertise to aid in the development of the research strategy for clinical trials; provide subject matter expertise in clinical trial site selection, site set-up, and subject recruitment and retention
• Provide subject matter expertise to Project Manager (PjM)/Product Manager (PdM) regarding site investigator selection and issues related to clinical trial staff training; provide input on issues related to local clinical trial site administrative and operational issues, including the preparation of clinical trial agreements and site- and study-specific document. 
• Attend and participate in site visits, IPT meetings and briefings, and sub-working group and investigator meetings.
• Orchestrate the requisite regulatory strategy as well as organization and compliance activities as contained in USAMRDC regulations, policies, pamphlets, and SOP.
• Interact with USAMMDA, USAMRDC, and other Government Agencies to assist in identifying, interpreting, prioritizing, and analyzing FDA, CFR, DoD, DA, USAMRDC policies, regulations, and guidance documents as they relate to products in different stages of development.
• Coordinate and assist with Joint Trauma System (JTS) to develop Clinical Practice Guideline(s) in support of the full rate decision or off-label use of the materiel solution.
• Collaborate as necessary to identify regulatory affairs (RA) strategies that will optimize product development.  The
• Review and analyze summaries, progress reports, clinical protocols, investigator brochures, and safety profiles and safety surveillance data; facilitate an understanding of the requirements for compliance with all applicable FDA regulations. 
• Provide professional medical review of Investigational Device Exemption, IND protocols, IND packages, and plans for management of IND products.
• Provide subject matter expertise in pharmaceutical quality/chemistry, manufacturing, and controls (CMC)
• Perform audits and provide GMP compliance advice.
• Assist in the development of a comprehensive Integrated Master Plan/IMS of FDA and non-FDA regulatory and clinical activities (e.g., tasks, documents, meetings,) to include estimated timelines required to support the product development of devices, pharmaceuticals, and vaccines.

Qualifications

• Doctorate degree required
• 10 years of experience
• Capability of applying knowledge of the DoD’s acquisition process in conjunction with their expertise in performance of all tasks as stated above for the given clinical problem and relevant epidemiology.
• Capability to assess CMC related risk of commercial partners and provide professional medical review of Investigational Device Exemption, IND protocols, IND packages, and plans for management of IND products.
• Understanding of planning for future clinical trials and other pre-clinical trial milestones; coordination and assistance in the review of all pre-clinical trial documents.
• Ability to keep current files of all information disseminated by the FDA and other policy bodies that affect prod