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Director, Clinical Research Scientist

Advanced Clinical


Location:
Chadds Ford, Pennsylvania
Date:
05/24/2017
2017-05-242017-06-23
Categories:
  • Clinical Operations
Advanced Clinical
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Job Details

OVERVIEW

We are currently searching for a skilled professional to join a well-known client’s team as a Director, Clinical Research Scientist, in Chadds Ford, Pennsylvania.  The Director, Clinical Research Scientist is responsible for planning, implementation, managing, and reporting of clinical pharmacology trials while closely working with physicians, statisticians, pharmacokineticists, translational medicine, CMC, toxicology and other scientists within drug discovery. Their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity. 

RESPONSIBILITIES

  • Accountable and responsible for the clinical pharmacology deliverables
  • Development of clinical pharmacology development plans
  • Author protocols for clinical pharmacology studies and contribute to other clinical study protocols.
  • Drafting of clinical scientific documents such as IND, IND amendments, Investigator Brochures, Annual Reports and other FDA submissions
  • Design clinical pharmacology/exploratory development studies
  • Review SAPs and tables, listings, and figures
  • Review and summarize safety data in ongoing studies
  • Represent clinical pharmacology on project teams
  • Work closely with Clinical Operations and Project Management to ensure timely implementation of Clinical Pharmacology studies
  • Develop relationships with appropriate consultants
  • Write abstracts and present data at scientific meetings
  • Serve as liaison to project teams, CRO’s and others
  • Preparation of clinical pharmacology NDA documents

EXPERIENCE

  • A minimum of 5 years’ experience in pharmaceutical industry with at least 5 or more years of hands-on clinical pharmacology experience
  • Demonstrated ability to effectively present clinical pharmacology data, development plans and strategies to various audiences in both verbal and written form
  • Demonstrated ability to write clinical pharmacology results and conclusions for reports and regulatory documents that are clear and concise

EDUCATION

  • Pharm.D. or Ph.D. or M.D. in Pharmacology, Pharmacy, Biological Sciences

To be a best-fit your strengths must include

  • Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology. 
  • Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines. 
  • Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure. 
  • Problem-Solvers.  As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
  • Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.   
  • Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.  

About Advanced Clinical

Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.

Regarding your application

Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.