EpiBiologics
Director of Clinical Operations
EpiBiologics - California, Missouri, United States, 65018
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Director of Clinical Operations
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EpiBiologics Join to apply for the
Director of Clinical Operations
role at
EpiBiologics This range is provided by EpiBiologics. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range
$202,500.00/yr - $247,500.00/yr The Director of Clinical Operations will provide strategic leadership in support of our clinical development vision and manage and execute one or more first in human phase I-II global clinical trials. Description The ideal candidate must be able to manage all clinical operational aspects of one or more clinical trials. Experience in Early Phase clinical trial management is preferred, including study start-up activities, patient enrollment initiatives, study maintenance, and close-out. The applicant must be attentive to detail and able to contribute to writing study protocols, informed consent forms, study manuals, develop SOPs, etc. We are seeking an experienced leader capable of providing strategic insights and technical expertise while navigating a complex global clinical trial landscape. The candidate must maintain a balance between ensuring the highest quality standards and driving the vision for our platform under aggressive timelines. ESSENTIAL JOB FUNCTIONS: Provide leadership and oversight in all aspects of clinical operations, from planning and executing programs to project oversight Provide strategic operational input to Clinical Development Plan (CDP) and project plans Establish study/program milestones and ensure accurate tracking and reporting of study/program metrics, timelines, and critical study activities Creating and overseeing clinical trial budget Develop and maintain enrollment forecasts Identifying, assessing, and selecting study sites/PIs in partnership with CMO and Vendors (as applicable) Manage CROs and third-party vendors to ensure delivery against the contracted scope of work and budget Assist in executing and managing legal contracts from clinical sites, vendors, etc., in conjunction with outside legal counsel Participate in selecting CRO and vendors, including developing RFPs, budget negotiations, and management Develop and Finalize ICFs, protocols/amendments, IB, site budget/CTA, and contribute to IND filings Develop and assure compliance with SOPs, local regulations, and CFR, ICH, and GCP guidelines. Ensure development study plans and provide adequate oversight for vendor oversight, risk, safety, and communication Ensure ongoing TMF and data collection are on track and maintaining quality Drive & support preparation for data cleaning and cuts Study specific participation in system set-up for key systems (e.g., IVRS, EDC, TMF, other) Plan and oversee Investigator Meetings as applicable Provide supervision, coaching, and mentoring and contribute to hiring new staff. Ensuring cross-functional team project-specific training Hosting, documenting, and filing internal /external project team meetings Assess project risk through life of project and escalate/ problem solve as needed Proactively identify risks and develop and implement mitigation strategies Self-motivated and able to thrive in a fast-paced, start-up environment Plan, participate, and facilitate operational-level governance with vendors as appropriate Ensure timely and effective risk mitigation and escalation for projects and programs Provide senior executive management with project and program updates Leads collaborative teams for projects or groups both internal and external to business and across functional areas. Reacts well under pressure. Other Duties Travel to client or prospective locations, conferences, or other professional development and networking events Attend staff, departmental, and other required meetings and trainings Partner with cross-functional peers & staff to build execution plans & meet critical business milestones Able to travel ( Other duties as assigned REQUIRED QUALIFICATIONS, EDUCATION & COMPETENCIES: Level commensurate with experience Bachelor’s degree or equivalent is required Must have at least 10 years of relevant trial leadership experience in either sponsor or CRO Strong track record for successful study initiation and execution Sound knowledge of medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA, NICE, and other relevant guidelines and regulations Experience managing CROs and third-party vendors Experience in Finance Management, including but not limited to Budget Forecasting, Change Order Management Experience working with EDC, CTMS, and eTMF systems Strong interpersonal communication skills Able to prioritize critical business needs Able to engage in strategic business discussions and craft executive-level communications and materials Excellent cross-functional clinical project management skills Must have exceptional leadership skills, including motivation and delegation Computer and Equipment Skills Foundational computer skills, including Microsoft Office Suite and the Internet. Ability to navigate at a basic level within web-based applications Use of Outlook email and calendaring Advanced skills with Microsoft applications which may include Outlook, Word, Excel, PowerPoint, Access, and/or other web-based applications. May produce complex documents, perform analysis, and maintain databases Use of online teleconferencing software (e.g., Zoom or Teams) BENEFITS: 401(k) Plan Flexible Vacation program for Exempt Employees plus 12 paid Holidays and Winter Break Up to 10 weeks of paid Parental Bonding Leave Medical, Dental and Vision, Company Funded HSA Company-paid short and long-term disability, and life insurance Voluntary life insurance plans are available for employees and dependents All qualified applicants will receive consideration for employment without regard to race, color religion, disability, age, sex (including sexual orientation, gender identity and transgender status), national origin, veteran status, genetic information, or any other classification protected by federal, state, or local law. EpiBiologics is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. Note to External Recruiters: Submission of unsolicited resumes prior to an agreement set in place does not create any implied obligation. Seniority level
Seniority level Director Employment type
Employment type Full-time Job function
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Director of Clinical Operations
role at
EpiBiologics Join to apply for the
Director of Clinical Operations
role at
EpiBiologics This range is provided by EpiBiologics. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range
$202,500.00/yr - $247,500.00/yr The Director of Clinical Operations will provide strategic leadership in support of our clinical development vision and manage and execute one or more first in human phase I-II global clinical trials. Description The ideal candidate must be able to manage all clinical operational aspects of one or more clinical trials. Experience in Early Phase clinical trial management is preferred, including study start-up activities, patient enrollment initiatives, study maintenance, and close-out. The applicant must be attentive to detail and able to contribute to writing study protocols, informed consent forms, study manuals, develop SOPs, etc. We are seeking an experienced leader capable of providing strategic insights and technical expertise while navigating a complex global clinical trial landscape. The candidate must maintain a balance between ensuring the highest quality standards and driving the vision for our platform under aggressive timelines. ESSENTIAL JOB FUNCTIONS: Provide leadership and oversight in all aspects of clinical operations, from planning and executing programs to project oversight Provide strategic operational input to Clinical Development Plan (CDP) and project plans Establish study/program milestones and ensure accurate tracking and reporting of study/program metrics, timelines, and critical study activities Creating and overseeing clinical trial budget Develop and maintain enrollment forecasts Identifying, assessing, and selecting study sites/PIs in partnership with CMO and Vendors (as applicable) Manage CROs and third-party vendors to ensure delivery against the contracted scope of work and budget Assist in executing and managing legal contracts from clinical sites, vendors, etc., in conjunction with outside legal counsel Participate in selecting CRO and vendors, including developing RFPs, budget negotiations, and management Develop and Finalize ICFs, protocols/amendments, IB, site budget/CTA, and contribute to IND filings Develop and assure compliance with SOPs, local regulations, and CFR, ICH, and GCP guidelines. Ensure development study plans and provide adequate oversight for vendor oversight, risk, safety, and communication Ensure ongoing TMF and data collection are on track and maintaining quality Drive & support preparation for data cleaning and cuts Study specific participation in system set-up for key systems (e.g., IVRS, EDC, TMF, other) Plan and oversee Investigator Meetings as applicable Provide supervision, coaching, and mentoring and contribute to hiring new staff. Ensuring cross-functional team project-specific training Hosting, documenting, and filing internal /external project team meetings Assess project risk through life of project and escalate/ problem solve as needed Proactively identify risks and develop and implement mitigation strategies Self-motivated and able to thrive in a fast-paced, start-up environment Plan, participate, and facilitate operational-level governance with vendors as appropriate Ensure timely and effective risk mitigation and escalation for projects and programs Provide senior executive management with project and program updates Leads collaborative teams for projects or groups both internal and external to business and across functional areas. Reacts well under pressure. Other Duties Travel to client or prospective locations, conferences, or other professional development and networking events Attend staff, departmental, and other required meetings and trainings Partner with cross-functional peers & staff to build execution plans & meet critical business milestones Able to travel ( Other duties as assigned REQUIRED QUALIFICATIONS, EDUCATION & COMPETENCIES: Level commensurate with experience Bachelor’s degree or equivalent is required Must have at least 10 years of relevant trial leadership experience in either sponsor or CRO Strong track record for successful study initiation and execution Sound knowledge of medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA, NICE, and other relevant guidelines and regulations Experience managing CROs and third-party vendors Experience in Finance Management, including but not limited to Budget Forecasting, Change Order Management Experience working with EDC, CTMS, and eTMF systems Strong interpersonal communication skills Able to prioritize critical business needs Able to engage in strategic business discussions and craft executive-level communications and materials Excellent cross-functional clinical project management skills Must have exceptional leadership skills, including motivation and delegation Computer and Equipment Skills Foundational computer skills, including Microsoft Office Suite and the Internet. Ability to navigate at a basic level within web-based applications Use of Outlook email and calendaring Advanced skills with Microsoft applications which may include Outlook, Word, Excel, PowerPoint, Access, and/or other web-based applications. May produce complex documents, perform analysis, and maintain databases Use of online teleconferencing software (e.g., Zoom or Teams) BENEFITS: 401(k) Plan Flexible Vacation program for Exempt Employees plus 12 paid Holidays and Winter Break Up to 10 weeks of paid Parental Bonding Leave Medical, Dental and Vision, Company Funded HSA Company-paid short and long-term disability, and life insurance Voluntary life insurance plans are available for employees and dependents All qualified applicants will receive consideration for employment without regard to race, color religion, disability, age, sex (including sexual orientation, gender identity and transgender status), national origin, veteran status, genetic information, or any other classification protected by federal, state, or local law. EpiBiologics is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. Note to External Recruiters: Submission of unsolicited resumes prior to an agreement set in place does not create any implied obligation. Seniority level
Seniority level Director Employment type
Employment type Full-time Job function
Job function Science Referrals increase your chances of interviewing at EpiBiologics by 2x Get notified about new Director Clinical Operations jobs in
San Mateo County, CA . Menlo Park, CA $205,000.00-$230,000.00 1 month ago South San Francisco, CA $261,000.00-$325,000.00 4 days ago Associate Director/Director, Clinical Operations, Autoimmune
South San Francisco, CA $180,000.00-$240,000.00 10 months ago Redwood City, CA $265,000.00-$295,000.00 6 hours ago South San Francisco, CA $215,000.00-$230,000.00 3 weeks ago South San Francisco, CA $180,000.00-$225,000.00 2 months ago Director, Clinical Operations Study Management
Director, Oncology Patient Support Operations
Redwood City, CA $186,200.00-$273,800.00 3 days ago Associate Director, Clinical Operations - Oncology (Compound Lead)
Senior Director, Clinical Study Management
Millbrae, CA $252,000.00-$275,500.00 2 weeks ago Director, Patient Access & Trade Analytics and Operations
Redwood City, CA $225,000.00-$265,000.00 1 week ago South San Francisco, CA $235,000.00-$280,000.00 3 days ago Director/Senior Director, Clinical Data Management
Millbrae, CA $165,000.00-$180,500.00 18 hours ago Sr. Director, Clinical Research - Oncology (Sr. Medical Director)
San Mateo County, CA $275,000.00-$325,000.00 2 weeks ago Senior Director, Clinical Data Management
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San Mateo County, CA $150.00-$175.00 5 days ago Executive Director, Clinical Pharmacology
San Mateo County, CA $115.00-$125.00 1 week ago South San Francisco, CA $220,000.00-$245,000.00 1 month ago Foster City, CA $160,000.00-$200,000.00 1 month ago South San Francisco, CA $156,000.00-$296,500.00 2 days ago San Mateo, CA $217,000.00-$301,000.00 1 week ago Foster City, CA $243,100.00-$314,600.00 1 week ago Executive Director, Global Clinical Supply Chain - Oncology
Foster City, CA $281,010.00-$363,660.00 9 minutes ago Clinical Research Principal Investigator MD/DO
Medical Director, Oncology Early Development
South San Francisco, CA $234,000.00-$444,000.00 5 days ago Late Stage Clinical Scientist TA Head (Sr. Director)
South San Francisco, CA $204,700.00-$341,100.00 3 days ago Director of Operations & Chief Compliance Officer
Foster City, CA $160,000.00-$200,000.00 2 months ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr