POSITION: Non-Clinical Advisor IV, V
LOCATION: Ft. Detrick, MD
TRAVEL: Up to 25%
CLEARANCE: Active Secret Security Clearance required
BENEFITS: 401K, Life/Health/ Dental/Disability Insurance, Paid Time Off, and Tuition Reimbursement.
- Interpret the meaning of information for others, to include:
- Translating or explaining what the information means and how it can be used
- Generating, interpreting, and communicating results from in vivo pre-clinical/non-clinical studies to teams of biochemists, biologists, pharmacologists, program managers, and non-scientists
- Preparing white papers and briefings for meetings, to include internal and external stakeholders
- Review the CRO’s or other performers’ implementation of activities to ensure they are in compliance with good laboratory practices, standard operating procedures, protocols, and regulations related to ethics and animal welfare.
- Ensure that experimental data are being properly collected.
- Should any deviations to protocol occur, properly document them or review the deviations for study impact (if any).
- Participate in audits as needed.
- Maintain current technical knowledge and skills, applying them to the job as necessary.
- Work with IPTs comprised of civilians, military and non-Government personnel, and matrix support staff with diverse areas of expertise, to include PMs, budget analysts, regulatory specialists, acquisition analysts, and logisticians.
- Work with diverse product development teams, to include Government personnel and the CRO or other performers (e.g., statisticians, biologists, toxicologists, clinicians, pharmacologists, formulation scientists, etc.).
- 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.
- Develop and maintain constructive and cooperative working relationships with others.
- Work independently and as part of a team.
- Provide consultation to multiple program management teams within the program management office, as well as contract performers, in the design of experimental studies and protocols, interpretation of experimental results, review of study reports, and recommendations from the Contract Research Organization (CRO) or other performer(s).
- Lead and work with IPTs and specialized working groups.
EDUCATION / EXPERIENCE REQUIRED:
- Must possess a PhD in Engineering, Physics, Chemistry, Biology, Engineering Management, or a related discipline, as well as twelve (12) years of general experience and eight (8) years of relevant experience.
- Alternate/Tradeoff Requirement: possess a Master’s degree in Engineering, Physics, Chemistry, Biology, Engineering Management, or a related discipline, as well as fourteen (14) years of general experience and ten (10) years of relevant experience.
- Possess strong technical training in non-clinical studies to support medical countermeasures in preclinical studies for an IND.
- Possess five (5) years of experience designing and conducting medical countermeasures in non-clinical toxicology studies for an IND.
- Possess the ability to independently design, critically evaluate, and execute non-clinical studies.
- Possess a familiarity and understanding of regulatory guidelines (i.e., FDA GLP and/or GMP) and regulatory/quality compliance requirements. Experience in a regulated laboratory environment is preferred.
- Possess strong interpersonal and communication skills, both oral and written.
- Possess strong critical thinking, analytical, and problem solving skills, as well as good organization skills to balance and prioritize work.
- Desired: The contractor may possess a DABT and/or DSP certification.
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.