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Clinical Development Manager
Ref No.: 18-00326
Location: Lawrenceville, New Jersey
Position Type:Contract
Start Date / End Date: 03/26/2018 to 09/25/2018
CLINICAL DEVELOPMENT MANAGER
LAWRENCEVILLE, NJ

Project Description:
  • The successful candidate will provide expert clinical input to the therapeutic area from discovery through early clinical development, registration and lifecycle management.
  • He/she is a knowledgeable medical monitor who will partner with development colleagues from CROs to design and implement strategically aligned, efficient clinical trials that meet ethical, scientific, safety, regulatory, and commercial objectives.
  • He/she will review and interpret clinical data, and guide appropriate recommendations and decisions on drug candidates under investigation.
  • He/she will contribute to strategic discussions on asset advancement and decision-making as data accrue.
  • Other responsibilities include contributions to the writing and review of responses and reports submitted to regulatory agencies, identifying and building relationships with thought leaders and investigators, and gathering input on disease areas and design of clinical programs.

Required Skills:
  • Minimum 5 yrs. of experience as a medical monitor with proven track record designing and overseeing clinical trials, ideally both early and late stage.
  • Experience supervising CRO-driven studies.
  • Experience with health authorities and regulatory submissions.
  • Understanding of the clinical development process, and the role of non-R&D functions:
    • Commercial, health outcomes, access, medical.
  • Proven ability to partner effectively with key internal and external stake.
  • Qualified individuals must possess an MD (or equivalent) or MD/PhD degree. Therapeutic background flexible, but rheumatology, inflammation/immunology and/or autoimmune disease background are preferred.
  • Experience in designing and executing clinical trials.
  • Expertise in implementing scientific methods to test hypotheses, design, analyze, interpret and report results.
  • Understanding of pharmacokinetics, biomarkers, statistical principles, and regulatory requirements.
  • Experience with heath authorities and regulatory submissions.
  • Comfortable working in a fast-paced environment.
  • Willing to work outside of a traditional functional environment, in a team unified around serving the assets.
  • Ability to recognize, articulate, and accept calculated risks to make informed decisions.
  • Willingness and ability to form strong, productive partnerships with internal and external stakeholders.
  • The candidate should have excellent communication skills and experience delivering effective presentations on both technical and nontechnical subjects.

This 6+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Bridget: bridget@alphaconsulting.com

ALPHA'S REQUIREMENT #18-00326
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE