Ossium Health
Senior Clinical Trial Manager/Associate Director, Clinical Operations
Ossium Health, San Francisco, California, United States, 94199
Ossium's mission is to improve the health, vitality, and longevity of human beings through bioengineering. We develop, manufacture, and bank cell therapy products that apply the power of stem cell science to revolutionize treatment for patients with blood, immune, and orthopedic diseases. At Ossium, we empower our employees, maintain the highest standards of operational excellence, and are a force for good.
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 yearsMS/MPH + 3-5 yearsCRO management experience or experience working in a CRO in a major capacity (Clinical Trial Manager level or above)Excellent written and oral communication skillsCapability to operate with a high level of organization and excellent time management in a dynamic startupProven skills from working in a project-oriented matrixed team environmentThis 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 dayAbility to travel as needed (5% - 10%)Preferred Qualifications
CRA/site coordinator experienceEnd-to-end experience in clinical trial management (CRO selection to study close out)Experience in data analysis and interpretationExperience in cell therapy areaExperience in rare disease indicationExperience working in startup environmentTherapeutic experience in any of the following areas:Hematologic malignancies (specifically bone marrow transplant)Graft versus host disease (GVHD)Solid organ transplantsKey Responsibilities
Delivering on the assigned clinical programs/studies as per the allocated budget and timelines with the Director of Clinical OperationsSupporting and executing on the operational strategy and clinical operations planSupporting the selection, oversight, and management of CROs and other vendorsReviewing 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 CROsOverseeing site feasibility/capability assessments in collaboration with the CRO and cross-functional teamPartnering and collaborating with cross-functional teams such as the CMC, Regulatory, and other relevant stakeholders for the successful execution of clinical trialsCoordinate and assist as required for conferencesAssisting in leading and overseeing the execution of first-in-human through phase III trials, in compliance with ICH/GCP and local regulationsAiding clinical trial data analysis and study report finalizationIn the first six months, some projects you'll work on include:
Supporting the active PRESERVE studySupporting CRO selection for an upcoming blood cancer studyCollaborating internally with other functions for clinical study implementationConducting clinical project team meetingsThis 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 salariesStock options401(k) matchingMedical, dental and vision coverageGenerous paid time off + 11 company holidaysEmployer paid life insurance and long-term disabilityGym membership/recreational sports reimbursements
Ossium provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, sexual orientation, gender identity or gender expression. Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records.
Principals / direct applicants only please. Recruiters, please do not contact this job poster.
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 yearsMS/MPH + 3-5 yearsCRO management experience or experience working in a CRO in a major capacity (Clinical Trial Manager level or above)Excellent written and oral communication skillsCapability to operate with a high level of organization and excellent time management in a dynamic startupProven skills from working in a project-oriented matrixed team environmentThis 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 dayAbility to travel as needed (5% - 10%)Preferred Qualifications
CRA/site coordinator experienceEnd-to-end experience in clinical trial management (CRO selection to study close out)Experience in data analysis and interpretationExperience in cell therapy areaExperience in rare disease indicationExperience working in startup environmentTherapeutic experience in any of the following areas:Hematologic malignancies (specifically bone marrow transplant)Graft versus host disease (GVHD)Solid organ transplantsKey Responsibilities
Delivering on the assigned clinical programs/studies as per the allocated budget and timelines with the Director of Clinical OperationsSupporting and executing on the operational strategy and clinical operations planSupporting the selection, oversight, and management of CROs and other vendorsReviewing 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 CROsOverseeing site feasibility/capability assessments in collaboration with the CRO and cross-functional teamPartnering and collaborating with cross-functional teams such as the CMC, Regulatory, and other relevant stakeholders for the successful execution of clinical trialsCoordinate and assist as required for conferencesAssisting in leading and overseeing the execution of first-in-human through phase III trials, in compliance with ICH/GCP and local regulationsAiding clinical trial data analysis and study report finalizationIn the first six months, some projects you'll work on include:
Supporting the active PRESERVE studySupporting CRO selection for an upcoming blood cancer studyCollaborating internally with other functions for clinical study implementationConducting clinical project team meetingsThis 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 salariesStock options401(k) matchingMedical, dental and vision coverageGenerous paid time off + 11 company holidaysEmployer paid life insurance and long-term disabilityGym membership/recreational sports reimbursements
Ossium provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, sexual orientation, gender identity or gender expression. Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records.
Principals / direct applicants only please. Recruiters, please do not contact this job poster.