Clinical Development and Safety SME

ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations. With our patients at the center of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

ICON Government and Public Health Solutions (IGP) is a full-service CRO specializing in preclinical through phase IV support of clinical research and clinical trial services for biologics, drugs, and devices. We help our customers get their products to market faster with an array of research, regulatory, and sponsor services. Globally, we respond rapidly to health crises and serve where few others do. We create a unique synergy in the global market, with projects spanning the government, academic, and commercial sectors. ICON Government and Public Health Solutions has a distinct ability to provide rapid response efforts to global health crises.

IGP is currently seeking a Clinical Development and Safety SME to support the Biomedical Advanced Research and Development Authority (BARDA).

Responsibilities Duties include, but not limited to:

• Support BARDA Program Office(s) as a subject matter expert in relevant field of experience(s) for vaccine, therapeutic, and/or antimicrobial advanced development; clinical and/or regulatory policy; and/or manufacturing capacity construction.
• Provide guidance documents and option papers on key issues related to the area(s) identified;
• Review contract proposal and related documents;
• Provide senior-level briefing(s) to ASPR/BARDA as required;
• Prepare regular reports to ASPR/BARDA management on various technical issues identified.
• Provide project development level portfolio management and oversight;
• Develop, implement, and consciously improve Total Life Cycle Cost (TLCC) efforts;
• Review contract proposal and related documents.
• Provide support to BARDA/Contractor Project Teams for assigned projects.
• Review Contractor (Sponsor) study reports, clinical development plans, regulatory documents, project plans and other technical documents for the assigned projects.
• Review of clinical, pharmacological, toxicological data and FDA submission packages, and other sections of regulatory submission documents as assigned.
• Provide guidance to BARDA personnel in their interactions with the FDA and external stakeholders and end-users relevant to the field of product development.
• Provide medical and product safety clinical development subject matter expertise for advanced development of therapeutics, vaccines, diagnostics, and devices related to COVID-19.
• Special emphasis of this position will be on COVID-19 clinical research and medical management aspects of interventional clinical trial design and execution leading to regulatory approval for advanced products, and on bringing this perspective to project teams at all developmental stages.

Minimum Required Qualifications:

• Citizenship: Must be a US citizen
• Clearance: Ability to obtain Public Trust
• Education: PhD in biology, chemistry, or pharmacy with commensurate experience.
• Years’ experience: Minimum of 15 years of relevant industry experience at senior regulatory affairs positions in the pharmaceutical industry;
• Deliverables would include work products related to the development and management of regulatory affairs strategic planning and guidance within current and planned BARDA vaccine, therapeutic, device/diagnostic, and/or antimicrobial advanced development and acquisition contracts.

Additional Information

• Location: Department of Health and Human Services 200 Independence Ave,SW Washington, DC 20201 United States
• Travel: 10%
• Remote,Onsite, or Hybrid: Onsite; telework eligible

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.