Clinical Operations and Regulatory Lead

Elixirgen Therapeutics is a startup biotech company developing cutting‑edge therapies for rare and aging‑associated diseases with one program in a Phase 1/2 trial. The company is inviting applications for a Clinical Operations and Regulatory Lead to join our dynamic team in advancing both the current and emerging therapeutics development programs.

• Leading day‑to‑day Sponsor‑side communications and operations for the Phase 1/2 clinical trial site, including monitoring and clinical operations
• Project management of the Phase 1/2 clinical program to ensure timelines and milestones are met
• Interfacing with stakeholders, including external consultants, CROs, investigators, IRBs, and data management teams to ensure protocol adherence and high‑quality data capture
• Assisting in drafting, reviewing, and submitting high‑impact regulatory documents (IND, NDA, BLA, safety reports, clinical study reports, meeting minutes)
• Ensuring all submissions meet FDA formatting, content, and electronic filing requirements
• Liaising with regulatory affairs team members to incorporate scientific data, statistical analyses, and risk‑benefit narratives

• BS/BA in Life Sciences, Nursing, Pharmacy, or related field
• Advanced degree (MS, MPH, or PhD) preferred

• 5‑8 years of experience in clinical trial management (preferably in biotech/pharma on the Sponsor or CRO‑side)
• Experience and familiarity in preparing FDA submissions (IND, NDA, etc.)

• Strong project management skills (MS Project, Smartsheet, or similar)
• Excellent scientific writing and editing ability; familiarity with eCTD submission format
• Proficiency in GCP/ICH guidelines and FDA regulatory pathways
• High emotional intelligence and communications skills to coordinate between project stakeholders
• Self‑starter with a “get‑things‑done” mindset
• Ability to thrive and think flexibly and quickly in a high‑stakes environment
• Passion for improving patient lives through innovative therapeutics

• Eligibility to work in the United States without sponsorship
• Able to commute to the office daily
• Willingness to travel up to 5% (potential site visits, regulatory meetings)

• Competitive salary commensurate with experience ($95,000‑110,000 annually)
• Comprehensive benefits package including retirement plans and health insurance
• Mission‑Driven Culture:
  Direct impact on life‑changing therapies for diseases without cures.

• To apply, please submit a CV and statement explaining your interest in this opportunity, along with up to three professional references.
• Applications should be emailed to i or submitted via Linkedin Jobs.
• The interview process includes a phone interview and in‑person interview at our office in Baltimore.