Research & Regulatory Coordinator

3 weeks ago

Doylestown, United States The O'Connor Group Full time

We are looking for a Research & Regulatory Coordinator for our client, Eliksa Therapeutics


Company Overview

Eliksa Therapeutics is an entrepreneurial, venture-backed biotech company specializing in developing treatments for rare diseases. Our lead product candidate, ELK-003, is a biological drug aimed at treating the ocular manifestations of epidermolysis bullosa. Our pilot clinical trial in Chile is scheduled to begin in May 2024.


Role Opportunity

We are seeking a dynamic and highly motivated Research & Regulatory Coordinator to lead pivotal phases of our company. This role is centered around steering the late preclinical and early clinical development stages of ELK-003.

This is a unique chance to influence the project's direction from an early stage, with ample opportunities for professional growth in a supportive and innovative environment. This position is perfect for someone who is ambitious, eager to grow within a fast-paced environment, and driven by a passion to make a significant difference in the lives of those affected by rare diseases. Our comprehensive benefits package complements a vibrant entrepreneurial culture.


Key Responsibilities

  • Drive the late preclinical and early clinical development phases of ELK-003
  • Coordinate external consultants, CROs, CDMOs, KOLs, and internal laboratory to advance the CMC of ELK-003
  • Ensure timely delivery of a preIND briefing document by CROs and manage preparations for the preIND meeting
  • Oversee coordination of IND-enabling studies and maintain project timelines to secure IND submission by 2026
  • Administer the project budget and handle monthly reports


Qualifications

  • 4+ years in progressive leadership roles within the biotech sector, managing critical development phases leading to clinical trials
  • Comprehensive knowledge of regulatory needs for submitting a successful IND for a biological topical drug like ELK-003
  • Proven ability to foresee project challenges, with strategies ready to mitigate risks
  • Expertise in managing multifaceted project teams and external partnerships, including CDMOs and clinical CROs, and internal laboratory
  • Exceptional organizational and project management skills, capable of detailed tracking and reporting
  • Experience working with DoD contracts as sponsors is highly valued
  • Educational background in science, preferably with PMP certification.
  • A proactive, hands-on approach with a strong "can-do" attitude and a passion for making a tangible impact in the field of rare diseases.
  • High attention to detail



Eliksa Therapeutics, Inc. is an Equal Opportunity Employer and will judge all applicants based on their qualifications for the job, without regard to race, color, sex, sexual orientation, religion, national origin, age, disability, or any other characteristics protected by applicable federal, state, or local law.

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