Clinical Scientist: Home or Office-based

***This is a Home or Office-based position. Candidates can be from anywhere in the US and/or the EU.

IQVIA is changing an entire industry through inspired innovation. Our People make the difference. We believe that great ideas can come from anywhere. Great products come from great ideas. And great ideas come from great people. We look for the very best people and then give them meaningful work to do. Join IQVIA and help us make the world a better place.

PURPOSE

The Clinical Scientist position is intended for an individual aspiring to lead full product development programs within the pharmaceutical industry. You will have responsibility for preparation of various work products of the Strategic Drug Development group that are part of product development process. These include: integrated product development plans; sections of Investigational New Drug (IND) applications; regulatory agency meeting documents; clinical study synopses and protocols; investigator brochures; supporting statistical documents; sections of marketing applications; target product profiles (TPPs); and clinical development plans (CDPs).

RESPONSIBILITIES

Duties of the Clinical Scientist include:

• Providing support and/or leadership for key deliverable outputs.

• Writing documents in support drug development projects. Documents including Protocol Synopses, FDA Meeting Request Letters (MRLs). FDA Meeting Information Packages (MIPs), CDPs, and TPPs.

• Researching current literature, including current product label, treatment guidelines, competitive landscape assessments and standard of care, to assist in the drug development lead in preparation for all deliverables.

• Summarizing animal and clinical studies to facilitate evaluation of the potential safety and efficacy of the drug under study.

• Supporting the drug development lead in assembling PowerPoint slides for client deliverables including indication prioritization, clinical development plans and target product profiles and contributing to the scientific decision making for the asset(s) various sections.

• Assisting in writing documents to support regulatory submissions including, but not limited to, clinical trial authorizations (INDs, CTAs), investigator brochures and protocols, marketing authorization applications (NDAs, BLAs, NDSs, MAAs), device authorizations (IDEs, 510Ks, PMAs).

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

• Masters degree (or equivalent). PhD, PharmD, or MD degree is preferred.

• Experience with medical, pharmaceutical, and/or research concepts.

• Minimum of two years’ work experience (e.g., student internships, postdoctoral fellowships, laboratory positions, or project management).

• Experience with principles of or project work involving Chemistry, Manufacturing, and Controls (CMC), nonclinical safety research, or clinical study design, management, or participation is desirable.

• Working knowledge of medical terminology and basic statistical concepts is strongly preferred.

• Proficiency in scientific writing (outlining, drafting, revising, and reviewing).

• Excellent reasoning capabilities, scientific acumen, and writing capabilities are required.

• Proficiency with software applications including Microsoft PowerPoint, Excel, Word, Project, Outlook, Teams, and Visio.

In addition, the successful applicant must be:

• Detail-oriented, thorough, and methodical.

• Able to reduce complex scientific data to its essence in tabular or summary form.

• Flexible and adaptable to changes in work duties, responsibilities, and requirements.

• Team-oriented individuals who keep others informed of the progress and status of projects.

• Able to focus on strategic objectives in a dynamic environment.

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At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.

IQVIA, Inc. provides reasonable accommodations for applicants with disabilities.  Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.