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15 days old

Director, Clinical Research Development

Kelly Services
Spring House, PA 19477
Kelly is currently seeking a Director, Clinical Research Development/ Sr Clinical Scientist for a long-term engagement with one of our Global Pharma Device clients in Spring House, PA


*****This position is semi remote as you will need to come to the site in Spring House twice a week*****


This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly.. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vison, 401K, and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.


**Summary of the Job** :


This position will support the Immunology products in development with indications in Pediatric Immunology, Rheumatology, or Gastroenterology.


The employee will support medical monitoring as well as protocol design, development, and execution. In addition, the incumbent would be expected to have input on IRB or Health Authority interactions and document writing, including the clinical background information for Pediatric Investigational Plans or Pediatric Study Plans.


**The responsibilities will include:**


+ Responsible for design, execution, and reporting of Phase 1,2 and 3 pediatric clinical trials.

+ Responsible for monitoring safety of clinical trials

+ Leads the development of the Integrated Study Plans (concept sheets, project plans, protocols, CRFs, operational and analytic plans) and study summaries, IND submissions, and technical reports.

+ Development of

+ Collaborates with early and late development clinical teams and Compound Development Teams to align pediatric strategy

+ Oversees the preparation of clinical portions of Immunology project PIPs, PSPs, INDs, IBs, CTAs, BLAs and other regulatory submissions.

+ Authorship of abstracts and manuscripts for publication based on clinical trial data.


**Qualifications:**


+ MD or DO is required

+ Pediatric experience desired, but not required

+ Experience in pharmaceutical drug development

+ Ability to work in a matrix environment with cross functional teams is essential

+ Strong leadership skills and the ability to influence is necessary


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2021-02-10 Expires: 2021-03-13

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Director, Clinical Research Development

Kelly Services
Spring House, PA 19477

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