About the Job

We are hiring a Senior Clinical Trial Manager/Associate Director, Clinical Operations to assist in the management of the execution of Ossium’s clinical trials & clinical operations activities. Specifically, this role will focus on day to day tactical aspects of clinical trials, CRO selection, trial implementation, trial monitoring, data delivery, and reporting. This position will play a key role in driving forward our foundational PRESERVE study (currently active) as well as future development of Ossium’s cell therapy products in several indications. The ideal candidate is willing to roll up their sleeves, and work effectively across multiple teams, working with both internal and external stakeholders for successful execution of the clinical trials and to assist in the management of internal operations as well as a CRO and external vendors.

This position reports to the Director, Clinical Operations.

Required Qualifications

• Degree in life sciences & industry-sponsored clinical trial experience:
• BS + 5 years
• MS/MPH + 3-5 years
• CRO management experience or experience working in a CRO in a major capacity (Clinical Trial Manager level or above)
• Excellent written and oral communication skills
• Capability to operate with a high level of organization and excellent time management in a dynamic startup
• Proven skills from working in a project-oriented matrixed team environment
• This position is based in our San Francisco office; we maintain a hybrid schedule of Monday - Thursday in the office, with Friday as a remote work day
• Ability to travel as needed (5% - 10%)

Preferred Qualifications

• CRA/site coordinator experience
• End-to-end experience in clinical trial management (CRO selection to study close out)
• Experience in data analysis and interpretation
• Experience in cell therapy area
• Experience in rare disease indication
• Experience working in startup environment
• Therapeutic experience in any of the following areas:
• Hematologic malignancies (specifically bone marrow transplant)
• Graft versus host disease (GVHD)
• Solid organ transplants

Key Responsibilities

• Delivering on the assigned clinical programs/studies as per the allocated budget and timelines with the Director of Clinical Operations
• Supporting and executing on the operational strategy and clinical operations plan
• Supporting the selection, oversight, and management of CROs and other vendors
• Reviewing and providing clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports, and other operational plan documents developed by the CROs
• Overseeing site feasibility/capability assessments in collaboration with the CRO and cross-functional team
• Partnering and collaborating with cross-functional teams such as the CMC, Regulatory, and other relevant stakeholders for the successful execution of clinical trials
• Coordinate and assist as required for conferences
• Assisting in leading and overseeing the execution of first-in-human through phase III trials, in compliance with ICH/GCP and local regulations
• Aiding clinical trial data analysis and study report finalization

In the first six months, some projects you’ll work on include:

• Supporting the active PRESERVE study
• Supporting CRO selection for an upcoming blood cancer study
• Collaborating internally with other functions for clinical study implementation
• Conducting clinical project team meetings

This position has a salary range of $140,000 - $204,000 annually. Ossium Health takes a market-based approach to pay. The successful candidate’s starting salary will be determined based on, but not limited to, job-related skills, experience, qualifications, and market conditions. This range may be modified in the future.

We offer a full slate of employee benefits including:

• Competitive salaries
• Stock options
• 401(k) matching
• Medical, dental and vision coverage
• Generous paid time off + 11 company holidays
• Employer paid life insurance and long-term disability
• Gym membership/recreational sports reimbursements