Clinical Operations Subject-Matter-Expert

Openkrill; United States; Remote; USD 150,000 - 250,000; Full time

Benefits offered by this job

Equity

Full healthcare coverage

Parental leave

Mental health support

401(k) matching

Health & wellness stipend

Job summary

Edison Scientific is seeking a Clinical Operations Subject Matter Expert to join our Forward Deployed team, working onsite with pharma and biotech partners alongside our engineers. Your job is to ensure our AI agents produce protocol-ready outputs that align with how clinical teams run studies.

You will evaluate AI agent performance on trial design tasks, create benchmarks, and work with client teams to embed AI into planning and execution.

Qualifications

• 5+ years of clinical operations or development experience in pharma/biotech.
• Bachelor's degree required; advanced degree preferred.
• Experience designing Phase I–III trials with study design and protocol development.
• Experience in oncology, immuno-oncology, immunology, cardiovascular, neurology, or hepatology (MASH).
• Knowledge of GCP and regulatory requirements for clinical trial conduct.

Responsibilities

• Evaluate and improve AI agent performance on clinical operations tasks including protocol development, study design, site feasibility, patient enrollment strategy, and clinical data analysis.
• Design benchmarks and acceptance criteria for clinical trial focused agent workflows.
• Partner with clinical operations and development teams at client organizations to integrate AI agents into their trial planning and execution workflows.
• Serve as the clinical operations authority on AI generated outputs, assessing operational feasibility, GCP compliance, and alignment with real world trial execution.
• Collaborate daily with Forward Deployed Engineers and Computational Biologists on each account.
• Support engagement scoping, success metrics, and technical evaluation with GTM.

Skills

Python proficiency

Education

Bachelor's degree

Advanced degree preferred

Tools

CTMS familiarity

EDC platforms

Trial analytics tools

Job description

ABOUT US

Edison Scientific builds and deploys AI scientist agents to accelerate science and the development of new medicines. We are an ambitious team run by scientists and engineers from leading institutions across biology, physics, chemistry, and AI.

ROLE

We're looking for a Clinical Operations Subject Matter Expert to join our Forward Deployed team, working onsite with pharma and biotech partners alongside our engineers. Your job: ensure our AI agents produce clinical trial outputs that are operationally sound, protocol ready, and aligned with how clinical teams actually run studies.

You'll evaluate agent performance on clinical trial design tasks, work with our partners' clinical operations and development teams to identify where AI can streamline their workflows, and bring real world trial execution knowledge to everything our platform generates. You're the person who knows whether an AI drafted protocol section or study design would hold up to regulatory standards.

This is embedded, partner facing work. You'll build relationships with clinical leaders, understand their operational constraints and regulatory requirements, and feed that knowledge back to our AI team to improve how our platform reasons about trial design, feasibility, and execution.

KEY RESPONSIBILITIES

• Evaluate and improve AI agent performance on clinical operations tasks including protocol development, study design, site feasibility, patient enrollment strategy, and clinical data analysis
• Design benchmarks and acceptance criteria for clinical trial focused agent workflows
• Partner with clinical operations and development teams at client organizations to integrate AI agents into their trial planning and execution workflows
• Serve as the clinical operations authority on AI generated outputs, assessing operational feasibility, GCP compliance, and alignment with real world trial execution
• Collaborate daily with Forward Deployed Engineers and Computational Biologists on each account
• Support engagement scoping, success metrics, and technical evaluation with GTM

REQUIRED QUALIFICATIONS

• 5+ years of experience in clinical operations or clinical development within the pharmaceutical or biotechnology industry, ideally within a sponsor organization
• Bachelor's degree required; advanced degree preferred
• Experience designing Phase I through III clinical trials with strong expertise in study design and protocol development
• Experience in oncology, immuno oncology, immunology, cardiovascular, neurology, or hepatology (MASH) therapeutic areas
• Experience analyzing clinical trial data and translating findings into operational decisions
• Strong knowledge of GCP guidelines and regulatory requirements for clinical trial conduct
• Familiarity with the end to end trial lifecycle from startup through closeout
• Ability to travel domestically 20-40% of the time

PREFERRED QUALIFICATIONS

• Medical monitoring or Study Management experience
• Familiarity with clinical trial management systems (CTMS), EDC platforms, or trial analytics tools
• Python proficiency
• High comfort with ambiguity and fast iteration

SALARY

$180k - $250k Offers equity

WHY JOIN US?

• Competitive salary and equity
• Full healthcare coverage; we pay 100% of premiums for you and your dependents
• Support for growing families, including a yearly new parent stipend and fertility coverage through Carrot
• Mental health support through Rula, our in-network therapist and psychiatrist network with fast availability
• 12 weeks of paid parental leave for maternity, paternity, and adoption
• Pet care support with a yearly employer-funded stipend for your animal companions
• Commuter benefits so you can pay for transit and parking with pre-tax dollars
• 401(k) company matching
• $300 health and wellness benefit quarterly
• Lunch is on us every day you're in the office, and dinner is on us when you're working late
• Regular team off-sites and company events

Edison Scientific is an equal opportunity employer. We do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other protected characteristic under applicable law.