Director – Clinical Research Scientist – Immunology/Gastroenterology Development

Clinical ResearchClinical ResearchFull TimeRemoteLeadTeam 10,001+Since 1876H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

68 days ago

Salary

$177K - $338.8K / year

Seniority

Lead

Postgraduate Degree3 yrs expEnglish

Job Description

• The primary responsibilities of the Development CRS are generally related to late-phase and marketed compounds. • Clinical Planning: product lifecycle plan, clinical strategies, development plans and study protocol design. • Provide subject matter expertise and keep updated with the pre-clinical and clinical data relevant to the molecule. • Clinical Trial Execution and Support: Plans, collaborates on and reviews scientific content of clinical documents such as protocols, informed consent documents, final study reports, and submissions. • Supports the monitoring of patient safety during study and engages in the global product safety reviews. • Cross function collaboration with clinical trial teams in the design, conduct and reporting of mid to late phase clinical trials. • Conduct study start-up meetings, investigator meetings and other activities to provide the appropriate training and information to investigators and site personnel. • Engage in reporting of clinical trial data in Clinical Trial Registry activities. • Support the planning of symposia, advisory board meetings, and other meetings with health care professionals. • Establish and maintain collaborations and relationships with thought leaders. • Support clinical trial data analysis and publications. • Provide medical expertise to regulatory scientists and support regulatory strategy.

Job Requirements

  • An advanced health/medical/scientific (for example, in Pharmacology, physiology, microbiology) or related graduate degree such as, PharmD, PhD
  • 3+ years of clinical development experience, including mid-to-late-stage development
  • Demonstrated ability to balance scientific priorities with business priorities with examples of successful leadership skills
  • Demonstrated strong communication, interpersonal, teamwork, organizational, and negotiation skills
  • Previous GI drug development experience
  • Pediatric drug development experience
  • Oral/written communication/listening skills are essential
  • Strong relationship-building and interaction skills with peers and management

Benefits

  • eligibility to participate in a company-sponsored 401(k)
  • pension
  • vacation benefits
  • eligibility for medical, dental, vision and prescription drug benefits
  • flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
  • life insurance and death benefits
  • certain time off and leave of absence benefits
  • well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

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