Medical Director – HIV Research, Clinical/Observational Research

Medical DirectorMedical DirectorFull TimeRemoteSeniorTeam 10,001+H1B SponsorCompany SiteLinkedIn

Location

Arizona + 4 moreAll locations: Arizona | California | Maine | Ohio | Rhode Island

Posted

3 days ago

Salary

$146K - $277K / year

Seniority

Senior

Postgraduate DegreeEnglishGoogle Cloud Platform

Job Description

Medical Director – HIV Research, Clinical/Observational Research

Syneos Health

• Provides medical oversight of assigned clinical studies in the duty as a medical monitor • Often serves as primary medical contact for customers for assigned clinical studies • Provides medical input and oversight in support of the Drug Safety and Pharmacovigilance department • Responsible for protocol design and development, upon request • Provides input into protocol amendments • Develops and delivers project-specific and therapeutic training to project team members and clinical site staff; provides training to customer staff as needed • Provides medical and therapeutic input to Study Start Up, Feasibility, and Subject Identification efforts • Provides medical input into data collection tools, monitoring plans, and review and analysis plans • Provides oversight to assigned Medical Scientist staff and Medical Director colleagues to review clinical data • Presents identified trends and issues, and mitigation strategies, to customers and project team members to minimize risks to subject safety or integrity of study data • Provides after-hours medical coverage for clinical studies • Adheres to all enterprise policies, work instructions, standard operating procedures, and project plans • Adheres to customer policies and standard operating procedures, as required in project plans • Maintains in-depth knowledge of FDA and worldwide drug development regulations and national and ICH Good Clinical Practice (GCP) guidelines • May support responses to Requests for Proposals (RFPs) or Bid Defense Meetings (BDMs), upon request • May provide input to clinical development or regulatory teams within the Company, upon request • May represent the Company at scientific meetings, upon request

Job Requirements

  • Doctorate degree in medicine and clinical experience in the practice of medicine in the specific therapeutic area
  • Clinical research experience required
  • In depth knowledge of FDA and worldwide drug development regulations
  • A strong understanding of the use of medical terminology and of drug names in multiple nations and environments is required
  • Experience working in matrix teams is preferred
  • Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint)
  • Effective organizational and interpersonal skills, communication and language skills, and group presentation skills
  • Above average attention to detail, accuracy, organizational, interpersonal, and team-oriented skills
  • Ability to handle multiple tasks to meet deadlines in a dynamic environment is essential
  • Ability to be customer-focused and have a disciplined approach to work is critical
  • Fluency in written and spoken English is essential
  • Up to 25% travel may be required

Benefits

  • Health benefits to include Medical, Dental and Vision
  • Company match 401k
  • Eligibility to participate in Employee Stock Purchase Plan
  • Eligibility to earn commissions/bonus based on company and individual performance
  • Flexible paid time off (PTO) and sick time
  • Company car or car allowance

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