Project Manager - Doylestown, United States - The O'Connor Group

The O'Connor Group Doylestown, United States

1 week ago

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 Project Manager 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

Requirements

Qualifications:

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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