Director, Clinical Operations

The role

The Director of Clinical Operations will lead the execution and strategy of global Phase I-III cell therapy clinical trials. This person will oversee operational strategy, manage cross-functional teams, and build internal clinical capacity.

What you will do

• Lead end-to-end operational strategy, startup, execution, and closeout of global Phase I-III cell therapy clinical trials.
• Translate clinical development plans into operational milestones, budgets, resource plans, and risk-mitigation strategies.
• Direct cross-functional study execution teams.
• Partner with CMC and Supply Chain to establish specialized cell therapy protocols.
• Author, review, and standardize trial-related documents and SOPs.
• Drive international site identification, feasibility, qualification, and activation.
• Manage clinical portions of regional regulatory submissions and ethics approvals.
• Develop country-specific patient recruitment and retention strategies.
• Identify, build, and nurture key opinion leader and site investigator partnerships.
• Lead vendor selection and maintain oversight of CROs, central labs, and specialty providers.

Required qualifications

• Bachelor’s degree in Life Sciences, Nursing or related scientific discipline
• 8 years of related experience in clinical trials
• 4 years in a leadership position
• Understanding and application of ICH Guidelines, Code of Federal Regulations and GCP
• Working knowledge of the complex logistics unique to cell therapies
• Track record of managing multi-center, multi-national Phase I-III trials
• Experience issuing RFPs, selecting CROs and speciality vendors, and managing complex program budgets
• Deep understanding of global regulatory frameworks governing ATMP’s / cellular therapy regenerative medicines

Nice to have

• Masters degree
• Developing cell or gene therapy products including rare diseases
• Leading early clinical development programs including the launch of first-in-human trials
• Experience working in early-stage, fast-paced biotechnology environments with lean internal teams
• Surgical route of administration for investigational products

Benefits

• Equity
• Comprehensive benefits package
• Support for continuous learning and career progression

About the company

Aspect Biosystems is a biotechnology company pioneering the development of a novel category of regenerative medicine. The company uses a full-stack tissue therapeutic platform to advance a therapeutic pipeline across multiple endocrine and metabolic diseases.