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Interior Designer

Patricio Enterprises

Interior Designer

Frederick, MD
Paid
  • Responsibilities

    POSITION: Clinical Advisor V

    LOCATION: Ft. Detrick, MD

    STATUS: Contingent         

    TRAVEL: Up to 25%

    CLEARANCE: Active Secret Clearance Required

    BENEFITS: 401K, Life/Health/ Dental/Disability Insurance, Paid Time Off, and Tuition Reimbursement.

    DESCRIPTION:

    PRIMARY DUTIES WILL INCLUDE (BUT NOT LIMITED TO): 

    • Serve as the clinical representative on project teams and support risk planning efforts in the context of development of medical countermeasures for chemical and biological WMD threats.
    • In collaboration with project team members, the Clinical Advisor will lead the writing of clinical development plans.
    • Develop drafts and assist the project team to coordinate responsibilities, oversee quality management, and encourage timeliness of completion of clinical study reports, IND applications, investigator brochures, CTAs, ISSs, ISEs, and other regulatory submissions and clinical expert reports.
    • Collaborate with both internal and external partners, contributing to data analyses in order to create and submit clinical study results to publications or the FDA and participating in the evaluation of safety results in clinical studies in order to assist in formulating the emerging safety and risk/benefit profile of products in development for clinical trials and regulatory documents (e.g., IND, investigator brochure, informed consent, etc.).
    • Assist the regulatory team in developing a robust product development plan to support FDA approval under the Animal Rule, assisting the regulatory team in establishing a link between clinical and non-clinical efficacy.
    • Review draft clinical protocols and provide feedback.
    • Review and search medical literature and databases in order to identify clinical and technical information and to provide references to support clinical plans.
    • Author, edit, and contribute to preparation of technical reports, such as overall project concepts and descriptions, test plans and technical reports
    • Work closely with nonclinical team to bridge nonclinical outcomes to the clinical disease course. Basic understanding of key assays needed to establish a correlate of protection.
    • Provide consultation to clients in the design of experimental studies and protocols, interpretation of experimental results, review of study reports, and recommendations from the Clinical Research Organization (CRO) or other performer(s).
    • Review the CRO’s or other performers’ implementation of activities to ensure they are in compliance with good clinical practices, standard operating procedures, protocols, and regulations related to ethics of clinical trial execution:
      • The contractor shall ensure that clinical data are being properly collected.
      • The contractor shall participate in audits/site visits as needed.
    • Maintain current technical knowledge and skills, applying them to the job as necessary.
    • Work with Integrated Product Teams (IPTs) comprised of civilians, military and non-Government personnel, and matrix support staff with diverse areas of expertise, to include program managers, budget analysts, regulatory specialists, acquisition analysts, and logisticians.
    • Work with diverse product development teams, to include Government personnel and the CRO or other performers, such as statisticians, biologists, toxicologists, clinicians, pharmacologists, and formulation scientists.
    • Represent the organization, communicating with individuals both in and outside the organization, to include customers, the public, and other Government agencies and external sources.
    • Maintain communication with supervisors, peers, or subordinates via telephone, e-mail, or in person, as required.
    • Develop and maintain constructive and cooperative working relationships with others.
    • Work independently and as part of a team, and must have strong interpersonal and communication skills, both oral and written.

    EDUCATION / EXPERIENCE REQUIRED:

    • Doctor of Medicine or Doctor of Osteopathy degree, and certification in Internal Medicine. Subspecialty certification in infectious diseases is preferred.
    • Ten (10) years of general experience including five (5) years conducting clinical trials. 
    • Alternate Education: The contractor shall possess a Master's degree in Nursing or Biology and ten (10) years of clinical trial management experience.
    • Knowledge of disease pathology in humans and linking that to the nonclinical efforts, specifically in the areas of filoviruses, plague, botulinum, and chemical nerve agents.
    • In depth senior level experience in clinical protocol development from early vaccine development to late stage vaccine development; informed consent; IRB approval process; and safety monitoring board.
    • Knowledge on FDA submissions and associated FDA regulations and guidelines. Knowledge working with CBER is preferred, and experience with programs in between phase 2 and phase 3 clinical trials.
    • Strong interpersonal and communication skills, both oral and written.
    • Working knowledge of the Special Immunization Program (SIP) at USAMRIID.
    • Possess the ability to independently design clinical protocols.
    • Possess strong critical thinking, analytical, and problem solving skills, as well as good organization skills to balance and prioritize work.

     

    EOE. PROTECTED VETERANS/INDIVIDUALS WITH DISABILITIES. Patricio Enterprises Inc. 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 status, protected veteran status, or any other characteristic protected by law.

     

    Required Skills Required Experience

  • Qualifications

    KNOWLEDGE, SKILLS & ABILITIES

     EDUCATION & EXPERIENCE:

    • Minimum of a Bachelors of Science in Engineering or Physics
    • 5-10 years experience as an Antenna or Radome Engineer in Aerospace or RF Microwave industry
    • Must have an active US Government security clearance.

     COMPUTER SKILLS:

    • Basic PC knowledge
    • MS Office Suite capability
    • Experience with electromagnetic CAE tools such as HFSS and FEKO

     

    PHYSICAL/MENTAL DEMANDS & WORK ENVIRONMENT:          

    Position involves sitting, standing and/or walking.  Position requires ability to frequently exert up to 10 pounds of force to move objects and occasionally exert up to 20 pounds of force to move objects.

     

    The work site is an industrial manufacturing operation and Personal Protective Equipment (PPE) may be required in some aspects of the role.

     

    Work usually performed in air-conditioned office environment. 

     

     

    To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this job.  This job description is not intended to be all-inclusive.  An employee may also perform other reasonably related business duties as assigned by his/her supervisor.