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21 days old

Director of Clinical Development, Immunology

Kelly Services
Philadelphia, PA 19133
Kelly is currently seeking a Director, Clinical Immunology for a long-term engagement with one of our Global clients remote.


This role is a full-time, offering our enhanced benefit package options. As a Kelly employee within this group, you will be eligible for Medical, Dental, 401K and a variety of other benefits options to choose from. This includes paid time off, including holiday, vacation, and sick/personal time unless told otherwise. All KellyFSP employees receive annual performance reviews.


+ **JOB GOAL:**

+ The Director Clinical Research is responsible for leading the trial teams responsible for conducting Phase II and III clinical trials.


+ **RESPONSIBILITIES:**

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

+ Responsible for monitoring safety of clinical trials and providing scientific leadership in the area of responsibility.

+ Provide scientific leadership of Phase 2 and 3 clinical trial teams.

+ Provide scientific expertise through entire clinical trial process including interactions with commercial and all level of management.

+ Leads the development of the Integrated Study Plans (concept sheets, project plans, protocols, CRFs, operational and analytic plans) and study study summaries, IND submissions, and technical reports. Provides input to strategic decisions regarding therapeutic indications.

+ Assists in financial negotiations and contract development with third party vendors (e.g., consultants, CROS and investigational sites.

+ Responsible for the scientific content of status reports for upper management and clinical/project team use.

+ Assists in the development, management, and tracking of the departmental/project budget.

+ Accountable for significant contributions to development of functional or DAS clinical strategy

+ Participates in Cross Departmental Workstream

+ May lead cross-functional projects with broad Janssen impact

+ Presents data and scientific information to the organization at all levels.

+ May be Clinical representative on a CDT or DAS.

+ May be Publication Team Leader

+ May act, in concert with senior clinical leader and CDT leader, as a company spokesperson regarding publication of clinical research findings and presentations to relevant health authorities (e.g. pre-NDA meeting) and consultant/advisory meetings

+ Builds credible relationships with opinion leaders

+ External alliances for partnered products when relevant


+ **QUALIFICATIONS:**

+ MD or PhD degree required.

+ Pharma experience in development of the drugs in rare diseases is required. Pediatrics, hematology, maternal fetal specialty is desired.

+ Knowledge of regulations for pharmaceutical industry and management of clinical trials.


\#acrp


**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 (plus, did we mention we provide a ton of benefits ?). 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)
Posted: 2021-08-27 Expires: 2021-09-27

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Director of Clinical Development, Immunology

Kelly Services
Philadelphia, PA 19133

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