AmacaThera

Recruiter Contact

Darwin Shurig

Chief Executive Officer

Transforming therapeutics to make a difference in patient health

Biotechnology

Toronto, Ontario

AmacaThera is a clinical-stage biotechnology company revolutionizing drug delivery with its proprietary AmacaGel™ platform, enabling localized, sustained therapeutic release. Founded on the research of biomaterials expert Dr. Molly Shoichet, the company is advancing innovative solutions in post-surgical pain management and oncology, including AMT-143, a non-opioid anesthetic showing promising Phase 1 trial results. With a collaborative, science-driven culture, AmacaThera seeks passionate professionals eager to challenge conventional therapeutics and drive meaningful advancements in patient health. Joining AmacaThera means contributing to cutting-edge innovations that have the potential to transform medicine.

Learn about AmacaThera

Chief Medical Officer

Position Details

AmacaThera is a clinical-stage biotechnology company transforming therapeutics to make a difference in patient health. Their unique, injectable hydrogel platform provides localized, sustained drug delivery to improve patient outcomes across multiple therapeutic areas, including post‑surgical pain management, cancer and other hard‑to‑reach target areas. Our partner is looking to add a Fractional CMO position to the team that will convert to a permanent role on their Executive Leadership team as they move into their next round of funding. This critical leadership role with design and provider expert leadership for their Stage II clinical trial as the company moves into the next stage of it's exciting evolution.

Overview Qualifications Video Interview with Leadership

Overview

Example of skills discussed during frst NAP (Needs Analysis Profle)
though not an inclusive list
Previous Pharma CMO Experience and Leading Medical Advisory Board
Meetings
MD with Board Certifcation
Translational Medicine, Clinical Pharmacology, and Early-Stage development
Extensive experience in multiple therapeutic areas, including pain, oncology,
metabolic drugs, and anti-infectives
Phase I, II, III, IV Clinical Trial Experience
Experience with Phase II Clinical Trial Design & Protocol Development
Proven success in clinical research studies and trial design, with experience in
submitting IND, NDA, 505(b)(2), and CTA flings
Experience with the interactions with academic thought leaders,
investigators, cooperative groups, and other clinical stakeholders
Strong Leadership and Communication Skills
Qualifications

CMO requirements:

AmacaThera has conduced a Phase I clinical trial using AMT-143. To simplify the internal resources needed to run this trial, extensive competitive analysis was conducted and a CRO used to run the trial. The Phase I was relatively straightforward, investigating safety, PK, and PD. As AmacaThera moves into Phase II, the complexity will increase and a part time CMO is required. The Phase II will investigate efficacy in a hernia surgery and pain levels will be monitored. As a CRO will not be used for the Phase II and a hospital will be used, additional guidance will be required from AmacaThera.

The following provides a timeline and expectations from a CMO:

1-3 months (1-2 days/week)
- Work with AmacaThera’s regulatory team to design Phase II hernia study
- Opine on all aspect of the trial, pain scale, end points, safety
- Interact with CRO to finalize study design
3-6months (1 day/week)
- Execute and oversee Phase II hernia study
6+months (full time)
- Design full Phase II program for all surgical incisions
- Attend investor meetings
Video Interview with Leadership