- 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
- Minimum 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
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Research & Regulatory Coordinator - Doylestown, United States - The O'Connor Group
Description
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 Summary:
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:
