Senior​/Executive Director, Preclinical Development

Morphocell Technologies is seeking an accomplished preclinical development leader to play a
pivotal role in advancing its regenerative medicine platform and lead nonclinical strategy for its
liver disease programs. Reporting to the Chief Scientific Officer, the Senior/Executive Director,
Preclinical Development will provide scientific, translational, and operational leadership across
all aspects of preclinical development, with an immediate focus on advancing the company's
acute liver failure (ALF) and acute-on-chronic liver failure (ACLF) programs toward clinical
readiness.
This executive will be responsible for shaping and executing integrated nonclinical development
strategies, overseeing critical proof-of-concept and pivotal studies, and ensuring robust
regulatory alignment to support global clinical submissions. The successful candidate will bring
deep expertise in in vivo pharmacology and translational science, along with a demonstrated
track record of advancing innovative therapeutic programs from discovery through IND/CTA enabling
studies and into the clinic.
As a key member of Morphocell's scientific leadership team, this individual will lead and mentor
a multidisciplinary preclinical group, collaborate closely with Discovery, Technical Operations,
Engineering, Regulatory Affairs, and Clinical Development functions, and serve as a trusted
scientific advisor to senior leadership. The role offers a unique opportunity to influence the
future direction of a rapidly growing biotechnology company developing transformative
therapies for patients with severe liver disease.

• Develop and execute integrated preclinical development strategies that support progression of Morphocell's cell therapy programs from discovery through clinical development.
• the scientific design, execution, interpretation, and reporting of non-GLP and GLP pharmacology, pharmacokinetic, biocompatibility, toxicology, and safety studies.
• the company's next critical development milestones, including large-animal proof-of-concept studies and subsequent pivotal preclinical programs required for clinical advancement.
• Provide strategic oversight for the selection and utilization of relevant in vitro and in vivo animal models.
• preclinical data packages to identify scientific, translational, and regulatory risks while developing mitigation strategies that support successful clinical entry.
• nonclinical findings into compelling clinical and regulatory strategies supporting IND, CTA, and global health authority interactions.
• as the primary scientific lead for external preclinical partners and CROs, ensuring study quality, timeline adherence, budget management, and regulatory compliance.
• Author and review regulatory documentation, including study reports, Investigator's Brochures, briefing packages, and nonclinical sections of regulatory submissions.
• Lead, mentor, and develop a growing team of approximately 10 preclinical scientists,
• cross-functionally with Discovery, Technical Operations, Engineering, Regulatory Affairs, Quality, and Clinical Development teams to align scientific strategy with broader organizational objectives.
• complex scientific concepts, development risks, and strategic recommendations to executive leadership, investors, collaborators, and external stakeholders.
• Maintain awareness of emerging scientific advances, translational approaches, and evolving regulatory expectations in regenerative medicine, liver disease, and advanced therapeutics

• PhD, PharmD, DVM, MD, or equivalent advanced degree in Pharmacology, Toxicology, Biological Sciences, Translational Medicine, or a related discipline; DABT certification is considered a strong asset.
• 10+ years of progressive biotechnology and/or pharmaceutical industry experience in preclinical or translational development, including leadership responsibility.
• Demonstrated success advancing therapeutic programs through preclinical development, regulatory submissions, and clinical entry, with direct experience interacting with regulatory agencies.
• Proven leadership experience managing multidisciplinary scientific teams and developing talent within a dynamic, growth-oriented environment.

• Deep expertise in in vivo pharmacology, translational research, and nonclinical development strategy, ideally within biologics, cell therapies, regenerative medicine, or advanced therapeutics.
• Strong experience designing and overseeing GLP and non-GLP studies across pharmacology,…