Director, Clinical Operations

Aspect Biosystems; Fremont (CA); On-site; USD 185,000 - 270,000; Full time

Benefits offered by this job

Equity

Comprehensive benefits package

Career development support

Job summary

Aspect Biosystems Ltd. seeks a Director of Clinical Operations to lead global Phase I-III cell therapy trials. You will drive operational strategy, manage cross-functional teams, and partner with vendors to ensure quality and on-time delivery.

You will oversee study budgets, site activation, recruitment strategies, and regulatory submissions while maintaining ICH-GCP compliance in a fast-paced biotech setting.

Qualifications

• Bachelor's degree in Life Sciences or related field is required.
• 8 years of clinical trial experience with 4 years in leadership.
• Experience in cell/gene therapy products and early development.
• Strong knowledge of ICH-GCP and global regulatory frameworks.

Responsibilities

• Lead end-to-end operational strategy and execution of multicenter trials.
• Direct cross-functional study teams and manage budgets and timelines.
• Oversee vendor selection, negotiations, and performance governance.
• Develop site activation plans and recruitment strategies for trials.
• Ensure regulatory submissions and ethics approvals across regions.

Skills

Leadership

Clinical operations

Program management

Vendor management

Budgeting

Regulatory affairs

Education

Bachelor's degree in Life Sciences

Master's degree beneficial

Tools

eTMF systems

Job description

We are seeking an innovative and self-motivated Director of Clinical Operations to help lead clinical development of our advanced cell therapy programs. Reporting to the Chief Development Officer, you will oversee and directly contribute to the execution and strategy of the company’s global clinical trials. You will be key to establishing investigator, vendor, and cross-department partnerships while building our internal Clinical capacity as our pipeline advances. You’ll be joining a company committed to developing regenerative medicines that deliver life-changing, functional cures for patients living with serious diseases. This role could be based on-site in Vancouver, Canada or Fremont, California.

Responsibilities

• Lead the end-to-end operational strategy, startup, execution, and closeout of global Phase I-III cell therapy clinical trials, flexing to support additional responsibilities assigned by leadership.
• Translate clinical development plans into actionable operational milestones, study budgets, resource plans, and risk-mitigation strategies.
• Direct cross-functional study execution teams—including Clinical Development, Regulatory, Quality, CMC, and Data Management—while championing cross-departmental knowledge sharing.
• Partner with CMC and Supply Chain to establish specialized cell therapy protocols, including chain-of-identity (COI), chain-of-custody (COC), cryogenic transport, and site handling.
• Author, review, and standardize trial-related documents, protocols, informed consents, Investigator's Brochures, study manuals, and Clinical Operations SOPs.
• Drive international site identification, feasibility, qualification, and activation, targeting specialized academic medical centers, endocrinology units, and cell therapy treatment centers.
• Manage clinical portions of regional regulatory submissions (FDA, EMA, Health Canada, MHRA) and ethics approvals in collaboration with Regulatory Affairs and local CRO partners.
• Develop country-specific patient recruitment and retention strategies tailored to target populations.
• Identify, build, and nurture key opinion leader (KOL) and site investigator partnerships.
• Lead vendor selection (RFPs, bid defenses, negotiations) and maintain active oversight, performance governance, scope tracking, and quality management for CROs, central labs, and specialty providers.
• Create, negotiate, review, and approve clinical trial, vendor, site, and department budgets, as well as invoices, change orders, and accruals in partnership with Finance.
• Build and scale the Clinical department by establishing foundational SOPs, setting up eTMF structures, and hiring, training, and managing team members.
• Ensure all trial activities, sites, eTMF systems, and vendor records maintain inspection readiness and comply with ICH-GCP guidelines and global cell/gene therapy regulations

Qualifications & Experience

• Education: Bachelor’s degree in Life Sciences, Nursing or related scientific discipline required. A Masters degree would be highly beneficial to your application.
• Experience: 8 years of related experience with progressively increasing responsibilities in roles involving the conduct of clinical trials with 4 of those years in a leadership position (less experienced, driven individuals will be considered).
• You have previous experience in the following areas:
  • 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.
• Knowledge: You have a solid understanding and application of ICH Guidelines, Code of Federal Regulations and GCP. You have a proven working knowledge of the complex logistics unique to cell therapies. You have a track record of operationalizing and managing multi-center, multi-national Phase I-III trials. You have strong experience issuing RFP’s, selecting CRO’s and speciality vendors, and managing complex program budgets.
• You have a deep understanding of global regulatory frameworks governing advanced therapy medicinal products (ATMP’s) / cellular therapy regenerative medicines.
• You work with a sense of urgency, are results-driven, and thrive in a fast-paced, interdisciplinary, and entrepreneurial environment. You are willing to roll up your sleeves and do what it takes to get the job done.
• You are highly adaptable, agile, and poised when faced with change, ambiguity, and competing priorities.
• You love immersing yourself in difficult technical problems and coming up with solutions that work. You think outside the box and use your experience and intuition to identify when such solutions are realistic.
• You thrive in a multi-disciplinary team environment and believe that we can get further, faster by working together.

The hiring range for this role is $185,000 - $270,000 , annually. Our pay scales are based on market data to ensure that compensation is competitive and fair. Offered salaries will be based on a combination of factors including, but not limited to, job-related knowledge, skills, education, and experience. For candidates who exceed role requirements, we are open to exploring above-range offers. Base salary is just one part of the overall compensation at Aspect, team members also receive equity, a comprehensive benefits package, and support for continuous learning and career progression.

Who We Are

Aspect Biosystems is a biotechnology company pioneering the development of a novel category of regenerative medicine designed to restore or supplement biological function and deliver curative therapies for some of the most elusive diseases. Aspect is developing these bioengineered cellular medicines by applying its full-stack tissue therapeutic platform, which integrates proprietary AI-powered bioprinting technology, therapeutic cells, hypoimmune cell engineering, and advanced biomaterials. Aspect is advancing its therapeutic pipeline across multiple endocrine and metabolic diseases, including diabetes and rare endocrine disorders. If you are committed to making a real impact and accelerating the development of life-changing therapies, we want to hear from you!

Curious about our current perks and benefits? Learn more here.

All aspects of employment - including the decision to hire, promote, discipline, or terminate - are based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, color, religion, citizenship status, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, political affiliation, or any other status protected under federal, state, provincial, or local law.