Senior Clinical Trial Manager

Aditum Bio; California (MO); On-site; USD 185,000 - 195,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

401k and equity opportunities

Job summary

Aditum Bio is seeking a Senior Manager, Clinical Operations to lead early-stage trials across multiple portfolio companies. You will partner with cross-functional teams and CROs to ensure studies are conducted efficiently, compliantly, and with high quality in a fast-paced biotech incubator environment.

This hands-on role requires strong operational execution, vendor oversight, and the ability to drive study strategy, timelines, and risk management across Phase I and II studies.

Qualifications

• Experience leading Phase I/II trials with CROs in biotech or pharma settings.
• Strong knowledge of ICH-GCP and regulatory requirements.
• Proven ability to manage timelines, budgets and vendor performance.
• Excellent communication and cross-functional collaboration skills.

Responsibilities

• Lead day-to-day operational management of Phase I-II clinical trials across one or more portfolio companies.
• Partner with the Senior Director, Clinical Operations to execute study strategy, timelines, and risk mitigation plans.
• Develop study plans, enrollment forecasts, recruitment strategies, and tracking tools.
• Manage study start-up, including site feasibility and selection, regulatory/ethics submissions, vendors, investigator meetings, and patient enrollment.
• Monitor study performance, identify and elevate risks, and implement mitigation plans.
• Review monitoring reports, protocol deviations, vendor deliverables, and study metrics to ensure quality oversight.
• Oversee CROs and vendors to ensure quality, timelines, budgets, and contractual deliverables are met.
• Serve as the primary study clinical operations lead, partnering with Clinical Development, Biometrics, Data Management, Regulatory, Quality, and other functions.
• Lead study team and vendor governance meetings, driving accountability and timely issue resolution.
• Oversee studies from start‑up through database lock and closeout, ensuring ICH‑GCP compliance and inspection readiness.
• Partner with the eTMF manager and CRO to maintain a complete, current, and inspection‑ready TMF.
• Support clinical trial audits and inspections.
• Participate in review of patient profiles, tables, listings, and figures.
• Support study budgets, forecasts, invoice review, and clinical trial spend management.
• Improve clinical operations processes, SOPs, templates, and best practices for use across the portfolio.

Skills

Phase I Trials

Phase II Trials

Vendor management

Cross-functional collaboration

ICH-GCP knowledge

Regulatory submissions

Budget management

Project management

Attention to detail

Education

Bachelor's degree in Life Sciences

Advanced degree preferred

Job description

Company Overview

At Aditum Bio, our mission is to rapidly translate scientific discoveries into new medicines. Co-founded by industry veterans Joe Jimenez, former CEO of Novartis and Mark Fishman, former President of the Novartis Institutes for Biomedical Research, the firm in-licenses promising therapies that for some reason are not advancing toward the clinic. The firm focuses on the translational phase of medicine to generate data that can support full clinical development, and eventual market launch, to reach patients in need.

Position Summary

The Senior Manager, Clinical Operations will play a key role in the planning, execution, and oversight of early-stage clinical trials across assigned Aditum Bio portfolio companies. Reporting to the Senior Director, Clinical Operations, this individual will serve as an operational lead for one or more Phase I and Phase II studies, partnering closely with internal cross-functional teams and external CROs to ensure studies are conducted efficiently, compliantly, and with a high standard of quality. This is a hands‑on role that requires strong operational execution, vendor oversight, and the ability to thrive in a fast‑paced, lean biotech incubator environment supporting multiple portfolio companies.

Responsibilities

Study Leadership & Execution

• Lead day-to-day operational management of Phase I-II clinical trials across one or more portfolio companies.
• Partner with the Senior Director, Clinical Operations to execute study strategy, timelines, and risk mitigation plans.
• Develop study plans, enrollment forecasts, recruitment strategies, and tracking tools.
• Manage study start-up, including site feasibility and selection, regulatory/ethics submissions, vendors, investigator meetings, and patient enrollment.
• Monitor study performance, identify and elevate risks, and implement mitigation plans.
• Review monitoring reports, protocol deviations, vendor deliverables, and study metrics to ensure quality oversight.

Vendor & Cross-functional Partnership

• Oversee CROs and vendors to ensure quality, timelines, budgets, and contractual deliverables are met.
• Serve as the primary study clinical operations lead, partnering with Clinical Development, Biometrics, Data Management, Regulatory, Quality, and other functions.
• Lead study team and vendor governance meetings, driving accountability and timely issue resolution.

Quality, Compliance & Data Oversight

• Oversee studies from start‑up through database lock and closeout, ensuring ICH‑GCP compliance and inspection readiness.
• Partner with the eTMF manager and CRO to maintain a complete, current, and inspection‑ready TMF.
• Support clinical trial audits and inspections.
• Participate in review of patient profiles, tables, listings, and figures.

Budget & Process

• Support study budgets, forecasts, invoice review, and clinical trial spend management.
• Improve clinical operations processes, SOPs, templates, and best practices for use across the portfolio.

Qualifications

• Bachelor's degree in Life Sciences or a related scientific discipline; advanced degree preferred.
• Approximately 7+ years of progressive clinical operations experience within biotechnology, pharmaceutical, or CRO environments.
• Demonstrated experience managing Phase I and Phase II clinical trials with increasing operational responsibility.
• Experience serving as the operational lead for one or more clinical studies, including oversight of CROs and external vendors in a fast‑paced and dynamic environment.
• Experience reviewing data to identify discrepancies or trends that require clarification
• Strong understanding of clinical trial startup, execution, closeout, and vendor management in global or multi‑center studies.
• Working knowledge of ICH‑GCP, FDA, EMA, and other applicable clinical research regulations.
• Experience managing study timelines, budgets, study risks, and operational performance metrics.
• Demonstrated ability to successfully manage multiple priorities across concurrent development programs in a lean, matrixed organization.
• Strong organizational, project management, analytical, and problem‑solving skills with exceptional attention to detail.
• Excellent interpersonal and communication skills with the ability to build productive relationships across internal teams, investigators, vendors, and executive leadership.
• Biotech experience preferred

The range for this full‑time position is $185,000 - 195,000, plus a target bonus, equity compensation and benefits including medical, dental, vision, and 401k. Our salary ranges are determined by role, level and location. The range displayed on our postings reflects the minimum and maximum for new hire salaries. Within the range, individual pay is determined by interview performance, job‑related skills, experience and relevant education and training. Please note the range reflects base salary and does not include target bonus, equity or benefits.

We provide equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.