Internships

Atossa Genetics is a cutting edge medical diagnostic company specialized in early breast cancer diagnosis, monitoring, and treatment.

We accept enthusiastic, high quality undergraduate or graduate students interested in learning the industry as interns. Stipend may be awarded depending on the skills and experiences. Please send your resume and contact information for two references to internship@atossagenetics.com.

Current Opportunities

Director of Clinical Research 

The Director of Clinical Research is responsible for defining the clinical trial strategy and management of all clinical studies being conducted by Atossa Genetics, Inc. The Director will manage operational and logistical tasks of clinical development to ensure efficient execution of trials within established budgets and timelines, ensuring all activities occur in compliance with the appropriate regulations, including FDA regulations, IDE, 510 (k) guidelines etc. S/he will coordinate the efforts of internal and external resources to ensure fast patient recruitment, trial site selection, trial plan optimization and execution of trials with a focus on quality.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following.  Other duties may be assigned.

  • Executes the strategy of clinical research programs as determined by the R&D Senior Management Team, with leadership in designing studies and in the conduct and management of clinical studies;
  • Provides clinical research expertise, especially study design and data interpretation
  • Prepare and complete IRB for clinical studies.
  • Reads and develops clinical protocols and all associated materials given the scientific literature, clinical practice, and changes in the regulatory environment that impact study design and interpretation
  • Interprets clinical study results and writes corresponding reports
  • Contributes to research programs based on an understanding of the pathophysiology of disease, mechanism of action of drugs, and the relevance of targeted pathways in defined patient populations
  • Leads or participates on R&D Development Teams which are responsible for the design, and conduct of all clinical research programs
  • Collaborates with members of other groups in the company (e.g., Regulatory Affairs, Clinical Operations, Medical Affairs, Sales/Marketing) to achieve corporate goals
  • Provides support in defining the development strategy, with the R&D Senior Management team, for products in development (e.g., pipeline products, LCM programs)
  • Works collaboratively with Project Management and Clinical Operations in the design and conduct of clinical research studies
  • Participates in interactions with regulatory agencies
  • Develops and reviews FDA documents (e.g., briefing documents, IND, NDA) and study related documents (e.g., Investigator Brochure, CRFs, protocol, CSRs, etc.)
  • Works with sales and marketing to provide key review and feedback for new indications and promotional materials
  • Presents information and respond to questions from project teams, external vendors, KOLs, and customers
  • Ensures that quality, regulatory-compliant development projects are conducted on time and within budget, meeting corporate and R&D goals.
  • Develop and implement SOPs for clinical trials and related activities.
  • Develop and maintain professional relationships with academic and community-based physicians, clinicians and investigators to assure good clinical input to Atossa Genetics, Inc. product development process, marketing, and field sales force.

EDUCATION, EXPERIENCE AND/OR SKILLS REQUIRED

  • M.D. with 10+ years of experience in medical device or pharmaceutical industry with at least five years of hands-on managerial experience running clinical trials and managing teams.
  • Experience writing, reviewing and editing clinical protocols and study reports
  • Ability to exercise judgment and determine appropriate action
  • Ability to manage deadlines
  • Ability to work independently
  • Proven ability to provide solutions to a variety of technical problems of moderate scope and difficult complexity
  • Excellent written and verbal communication skills, including ability to effectively present information and respond to questions from project teams, external vendors, KOLs, and customers.
  • Knowledge of Good Clinical Practice (CGP).
  • Knowledge of Institutional Review Board (IRB)
  • Experience in IRB preparation and submission
  • Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Internet software, E-mail, Product Management Software

EXPERIENCE PREFERRED

  • Fellowship training or scientific expertise in cytology, immunocytological chemistry (ICC), next generation synergy, cancer treatment
  • Experience on product development teams
  • Experience interacting with the FDA on INDs, NDAs, and development programs
  • Working knowledge of guidelines and FDA regulations for prospective clinical trials
  • Experience and demonstrated success in working with KOLs, PIs and CROs.

To apply for this position please send your resume to hr@atossagenetics.com.

Project Manager

Provide leadership in the coordination of the design, development, verification, and documentation of medical device/pharmaceutical development projects.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following.  Other duties may be assigned.

  • Develop project plans for medical device/pharmaceutical development projects to satisfy Atossa’s expected milestones, budget and deadlines. Track and communicate project status, plans, risks, timelines, and budget on a weekly or ad-hoc basis.
  • Serve as point of contact within Atossa. Prepare for and chair meetings, coordinate site visits and day-to-day communications, and generate periodic progress reports.
  • Coordinate the development, verification, and documentation of medical device/pharmaceutical development projects according to regulatory standards and Atossa’s design control systems.
  • Support engineering activities as required including defining product requirements, generating design concepts, prototyping, writing test protocols and reports, participating in risk and hazards management activities, design verification and design transfer.
  • Organize and supervise engineers and technicians, and coordinate activities with different functional groups during the design development process (e.g. R&D, document control, quality, design transfer and manufacturing).
  • Assist in business development activities with review and/or preparation of project scope, timeline, and budget documents for proposals.

EDUCATION, EXPERIENCE AND/OR SKILLS REQUIRED

  • 5-10 years+ experience in design and development of medical device/pharmaceuticals, minimum 3 years in project management.
  • Bachelor’s Degree in Biology, Mechanical, Electrical, or Biomedical Engineering.
  • Experienced in applying various project management tools for tracking development projects against planned budgets and timelines.
  • Good computer skills including MS Project, Word, Excel, and PowerPoint.
  • Solid understanding of medical device/pharmaceutical design controls, standards, and regulations including GMP, GCP, ISO 13485 and 21 CFR 820.
  • Excellent communication skills both verbal and written. Good decision making and problem solving skills.
  • Must have experience with designing test methods, writing and conducting test protocols, and generating test reports for medical device/pharmaceuticals.
  • Must Have Direct Medical device/Pharmaceutical Experience.
  • Must have experience in creating presentations and effectively presenting technical concepts to clients and peers.

To apply for this position please send your resume to hr@atossagenetics.com.

Careers

If you are interested in employment at Atossa Genetics:

Please send your resume and the contact information of two references to hr@atossagenetics.com or send an email for more information.