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Associate Director, Clinical Regulatory

Eikon Therapeutics
Location
Jersey City, NJ
Posted
16 days ago
Department
Clinical Regulatory
Salary
$178,000 to $215,250
What they actually want (must-haves)
  • 10+ years of relevant experience with a Bachelor's degree, or 8+ years with a post graduate degree in a relevant scientific discipline
  • In-depth knowledge of international regulatory requirements and guidelines
  • Exceptional communication, negotiation, and project management skills
  • Proven ability to thrive in a collaborative, cross-functional team environment
  • Strong analytical skills, attention to detail, and effective problem-solving abilities
  • Adaptability and the ability to excel in a fast-paced, high-growth environment
Nice to have
  • Ability to interface well with submission platforms such as Clinical Trials Information System (CTIS) or Integrated Regulatory Information System (IRIS)
  • Familiarity with study and GMP documentation required by Health Authorities
What the job really is

The Associate Director, Clinical Regulatory at Eikon Therapeutics will manage regulatory clinical trial applications and ensure compliance with relevant regulations. This role involves developing ex-US submission strategies, collaborating with cross-functional teams, and liaising with regulatory agencies. The position requires a minimum of three days a week onsite in Jersey City, NJ, to facilitate effective management and collaboration.

Benefits
  • 401k plan with company matching
  • Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)
  • Mental health and wellness benefits
  • Weeklong summer and winter holiday shutdowns
  • Generous paid time off and holiday policies
  • Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies
Things to weigh
  • Minimum of three days a week onsite presence required
  • Role involves managing complex regulatory submissions across multiple international jurisdictions
  • High level of experience required may limit applicants
  • No salary listed beyond the expected range of $178,000 to $215,250
Job score4.4/5
Benefits4/5
Freshness4/5
Career value4/5
Role clarity5/5
Pay transparency5/5

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