INC Research/inVentiv Health is staffing multiple positions for our client based in Washington, DC. These positions are full-time perm/direct hires. Selected candidates must work in-house in DC, however, there can be some work from home flexibility for candidates who live in surrounding areas (MD/VA). Relocation candidates OK, Relocation assistance is available
Title of Position: Regulatory Leader, Drug-Device Combo Division
This person will be the Cornerstone to the new drug/device-combination product department
Can have a drug-device combo background, or just Drug background
10-20 year combination device/drug regulatory expert
Has been hands-on in leading the drug development process from non-clinical through phased clinical testing to product approval
Have a deep understanding of the drug development process and the FDA requirements and processes through each of these phases
Experience in neuro-musculoskeletal diseases and technologies would be preferred
Title of Position:Associate Director, Clinical Affairs
Strong drug/pharma Study Manager/Project Manager experience
Excellent communication skills
Phase II/III experience with some IND clinical experience
Title of Position: Director, Clinical Project Management
Title of Position: Senior Clinical Project Manager
One position will be filled with a candidate who has very strong drug/IND study background and marketable in IND studies
One position will be filled with a candidate who has a mixture of product, drug-and-device (IND and IDE study experience), however must have device/IDE study experience
BA/BS or equivalent degree in scientific discipline. Advance degree preferred (MA/MS, PharmD, PhD).
Minimum 7-8 years of clinical trial experience in a pharmaceutical, biotechnology, CRO
Have >8 years of experience managing IND studies; be well versed in regulatory requirements for managing Phase 1-4 studies
Experience/knowledge as a project manager in medical device studies is a plus.
Previous trial management experience to include:
Responsibility for the management and execution of the clinical project.
Execution of the Monitoring Plan in consultation with the cross-functional project team, clients and the clinical team.
Presentation of project plans, ongoing updates and project results to management.
Oversight of clinical projects to ensure safety concerns and/or adverse events or trends in Safety
Ability to work on 3-5 protocols at any given time
Ability to travel 10-20%
Additional Salary Information: Salary ranges are commensurate with background/experience. Annual bonus structure ranges from 5% thru 50% based on position grade/level
INC Research/inVentiv Health (Nasdaq: INCR) is the only fully integrated biopharmaceutical solutions organization. Our company, including a Contract Research Organization (CRO) and Contract Commercial Organization (CCO), is purpose-built to address new market realities where clinical and commercial share expertise, data and insights to accelerate biopharmaceutical performance. With more than 22,00...0 employees and the ability to support customers in more than 110 countries, our global scale and deep therapeutic alignment enables INC Research/inVentiv Health to help customers successfully navigate an increasingly complex environment. For more information on our Raleigh, N.C.-based company, visit incresearch.com or inventivhealth.com.