Sr Project Manager

Company Overview:

Eliksa Therapeutics is an entrepreneurial venturebacked biotech company specializing in developing treatments for rare diseases. Our lead product candidate ELK003 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 ELK003.

This is a unique chance to influence the projects 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 fastpaced 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 ELK003

Coordinate external consultants CROs CDMOs KOLs and internal laboratory to advance the CMC of ELK003

Ensure timely delivery of a preIND briefing document by CROs and manage preparations for the preIND meeting

Oversee coordination of INDenabling 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 ELK003

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 handson approach with a strong "cando" attitude and a passion for making a tangible impact in the field of rare diseases.

High attention to detail

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