Clinical Design Manager (Maplewood, MN)

  • Company: 3M
  • Location: Maplewood, Minnesota
  • Posted: October 11, 2017
  • Reference ID: R00047848
At 3M, we apply science in collaborative ways to improve lives daily. With $30 billion in sales, our 90,000 employees connect with customers all around the world.

3M has a long-standing reputation as a company committed to innovation. We provide the freedom to explore and encourage curiosity and creativity. We gain new insight from diverse thinking, and take risks on new ideas.

Here, you can apply your talent in bold ways that matter.

Job Description:

3M is seeking a Clinical Design Manager for the Drug Delivery Systems Division (DDSD) located in Maplewood, MN. Here, you go.

Job Summary:
The person hired for the position of Clinical Design Manager will provide clinical research deliverables for new product development programs within DDSD. DDSD operates in a Food and Drug Administration (FDA) and European Union (EU), mainly Medicines & Healthcare products Regulatory Agency (M&HRA), regulated environments with an excellent brand and quality reputation.

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Primary Responsibilities include but are not limited to the following:
  • Design clinical programs for the early development (phase I and II) of pharmaceutical products for global markets with an emphasis to US and Europe.
  • Design clinical protocols, Investigator's Brochures, and other supporting documents for clinical studies
  • Interpret and present pharmacokinetic and pharmacological data to internal development teams, partners and regulators
  • Author internal clinical reports, publish data, and prepare clinical documents for regulatory submission
  • Prepare and review preclinical and clinical safety assessments and biocompatibility testing in collaboration with toxicologists and pharmaceutical scientists

Basic Qualifications:
  • Advanced degree or higher in a Science discipline from an accredited university
  • Minimum of five (5) years of clinical research experience
  • Minimum of five (5) years of clinical study design experience
  • Minimum of three (3) years of combined experience working directly with U.S. and/or EU Regulatory authorities

Preferred Qualifications:
  • M.D/Ph.D.; PharmD; Ph.D. (Biological Chemistry, Biomedical Engineering, Chemistry or Biology) or related discipline from an accredited university
  • Expert knowledge of drug metabolism, pharmacokinetics, and pharmacology
  • Experience designing and preparing clinical protocols, writing clinical reports and/or contributing to clinical documents to support regulatory filings
  • Authorship experience within a minimum of three (3) U.S. or EU regulatory submissions
  • Understanding of statistics and experimental design
  • Experience in the clinical development of pharmaceutical or medical device products for global markets
  • Experience preparing clinical safety risk assessments
  • Direct interaction with regulators, such as attendance at a sponsor-regulator meeting with FDA or European agencies
  • Experience with the design and conduct of preclinical toxicology studies needed to support pharmaceutical and/or medical device development
  • Excellent written and oral communication skills including working familiarity with related information technologies
  • Excellent ability to multi-task and prioritize
  • Ability to work effectively on cross-functional teams in multiple global locations

Location: Maplewood, MN
Travel: May include up to 25% domestic/international

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