EPM Scientific:

Biosample Operations Manager

Position Summary: We are seeking a highly motivated Biosample Operations Manager with a passion for new cancer therapy development. This role will be responsible for providing leadership to Clinical Development Execution and/or Study Management Team and oversight of laboratory vendors for our clinical programs. As a Biosample Operations Manager, you will represent Clinical Operations and work directly with Biomarker Sciences, Pharmacology, Clinical Data Management, Medical Monitor, and other key functions both internally and externally to ensure successful completion of all clinical activities/project deliverables. You will apply your technical skills, learn new skills, and play a key role in clinical trial planning and execution. As a member of the team, you will help to grow the pipeline. What you'll do: Develop and maintain effective, collaborative relationships with internal study execution/management teams, CROs, laboratory service providers, and other key stakeholders. Manage key service providers (e.g., Central and other laboratories as needed) and CROs to support clinical sample tracking and collection, and sample storage including drafting and reviewing RFPs, vendor selection, defining scopes of work, vendor management, and contract management in support of study objectives and goals. Implement study-specific biosample analysis plan and data management or transfer agreement for each study. Lead the execution of biosample analysis logistics and timelines, from sample collection and processing, shipment, testing, data reconciliation and transfer, to final sample disposition, in accordance with study protocol and informed consent. Collaborate with biomarker sciences and pharmacology to oversee all study biosample operational activities and regularly report on status (e.g., reconciling against consent) including Key Performance Indicators. Support biomarker sciences and clinical development on Companion Diagnostics strategy development and lead the study execution on the strategy. Facilitate resolution of sample and data discrepancies. Write or contribute to the preparation of clinical documents (e.g., protocols, informed consent forms, case report forms, laboratory specifications, and manuals). Provide education and training for sample collection, handling, and shipment, which may include optimization of laboratory manuals, contributing to the development of patient and site-friendly sample collection materials, to investigators and site staff, vendor staff, and team members. Proactively identify areas of best practice and process improvements. Participate and/or lead Biosample Operations initiatives. Requirements: Bachelor's in life sciences or related discipline with 8-10 years of experience in clinical and drug development. Clinical or biological laboratory experience with involvement in the processing and/or analysis of biological samples. Extensive clinical trial management experience from study start-up through to close out, particularly in oncology and/or precision medicine early drug development. Familiar with oncology laboratory terminologies as well as genomic biomarker and pharmacodynamic endpoints from tissue and blood samples. Early phase oncology trial management experience preferred. Thorough knowledge of FDA and ICH/GCP regulations and guidelines. Self-motivated and takes pride in your work. Results-oriented team player; enjoy working collaboratively with colleagues and building positive relationships. Detailed oriented and creative thinker with a passion for process optimization. Excellent organizational and communication skills. Computer software literate, e.g., Microsoft suite including MS Excel and MS Project, Smartsheet, Adobe, and other clinical systems such as EDC, CTMS, TMF. Analyze and triage problems, prioritize accordingly, and propose solutions. If you are passionate about making a difference in the field of oncology and meet the above requirements, we would love to hear from you!

Negotiable

South San Francisco

US$165000 - US$195000 per year

Associate Director, Clinical Science

Job Type: Full-time Salary: $160,000 - $200,000 Location: Alameda, CA Company Summary: As private equity and VC backed clinical-stage biotech company, their mission is to develop a safe, effective, and affordable first-in-class cell therapy pipeline to treat cancer. To achieve this, they are focused on developing gamma delta T cell therapies with a patented ACC platform that targets immune cells. The Opportunity: The Associate Director, Clinical Science will play a critical role in the design, implementation, and analysis of clinical trials focused on our advance cell therapy programs. Reporting to the Executive Director of Clinical Development, this person will be responsible for collaborating cross-functionally to ensure completion of the clinical studies. Responsibilities: Developing and overseeing clinical trial protocols to ensure alignment with regulatory guidelines and strategic objectives. Leading the cross functional study set up activities for successful conduct of the study, with guidance from the clinical development lead physician. Assisting and/or lead drafting responses to regulatory agencies, IRB/EC, and study sites related to the study protocol, and ensure timely response to these requests. Performing periodic ongoing clinical data review from various EDC systems, contributing to the interpretation of results and providing actionable insights for study progression and decision-making. Preparing and reviewing clinical study reports, regulatory submissions, and manuscripts for scientific publication, ensuring accuracy and compliance. Interacting with regulatory agencies to support clinical trial applications and maintain compliance with regulatory standards. Staying abreast of advancements in oncology and cell therapy, integrating new findings into clinical strategies and practices. Providing guidance and mentorship to junior staff on best practices in clinical research and trial management. Requirements: Advanced degree in a relevant scientific discipline (e.g., oncology, immunology, cell biology, or nursing): Ph.D./MD/PharmD with 8-12+ years of experience, or M.S. with 12-15+ years of experience. Minimum of 5 years of experience in clinical research (i.e. performing study design, set up, and clinical data review) ' Experience in the following areas are preferred oncology, rheumatology/autoimmune disease, and cell therapy (allogenic or autologous) Regulatory submission experience is a plus. Benefits: Pre-IPO stock options Health benefits (medical, dental, and vision) Competitive salary with comprehensive benefits and PTO 401K contribution Collaboration with biopharmaceutical partners and worldwide academic institutes worldwide

Associate Director, Clinical Science

Job Type: Full-time Salary: $160,000 - $200,000 Location: Alameda, CA Company Summary: As private equity and VC backed clinical-stage biotech company, their mission is to develop a safe, effective, and affordable first-in-class cell therapy pipeline to treat cancer. To achieve this, they are focused on developing gamma delta T cell therapies with a patented ACC platform that targets immune cells. The Opportunity: The Associate Director, Clinical Science will play a critical role in the design, implementation, and analysis of clinical trials focused on our advance cell therapy programs. Reporting to the Executive Director of Clinical Development, this person will be responsible for collaborating cross-functionally to ensure completion of the clinical studies. Responsibilities: Developing and overseeing clinical trial protocols to ensure alignment with regulatory guidelines and strategic objectives. Leading the cross functional study set up activities for successful conduct of the study, with guidance from the clinical development lead physician. Assisting and/or lead drafting responses to regulatory agencies, IRB/EC, and study sites related to the study protocol, and ensure timely response to these requests. Performing periodic ongoing clinical data review from various EDC systems, contributing to the interpretation of results and providing actionable insights for study progression and decision-making. Preparing and reviewing clinical study reports, regulatory submissions, and manuscripts for scientific publication, ensuring accuracy and compliance. Interacting with regulatory agencies to support clinical trial applications and maintain compliance with regulatory standards. Staying abreast of advancements in oncology and cell therapy, integrating new findings into clinical strategies and practices. Providing guidance and mentorship to junior staff on best practices in clinical research and trial management. Requirements: Advanced degree in a relevant scientific discipline (e.g., oncology, immunology, cell biology, or nursing): Ph.D./MD/PharmD with 8-12+ years of experience, or M.S. with 12-15+ years of experience. Minimum of 5 years of experience in clinical research (i.e. performing study design, set up, and clinical data review) Experience in the following areas are preferred oncology, rheumatology/autoimmune disease, and cell therapy (allogenic or autologous) Regulatory submission experience is a plus Benefits: Pre-IPO stock options Health benefits (medical, dental, and vision) Competitive salary with comprehensive benefits and PTO 401K contribution Collaboration with biopharmaceutical partners and worldwide academic institutes worldwide

Associate Director, Clinical Science

Job Type: Full-time Salary: $160,000 - $200,000 Location: Alameda, CA Company Summary: As private equity and VC backed clinical-stage biotech company, their mission is to develop a safe, effective, and affordable first-in-class cell therapy pipeline to treat cancer. To achieve this, they are focused on developing gamma delta T cell therapies with a patented ACC platform that targets immune cells. The Opportunity: The Associate Director, Clinical Science will play a critical role in the design, implementation, and analysis of clinical trials focused on our advance cell therapy programs. Reporting to the Executive Director of Clinical Development, this person will be responsible for collaborating cross-functionally to ensure completion of the clinical studies. Responsibilities: Developing and overseeing clinical trial protocols to ensure alignment with regulatory guidelines and strategic objectives. Leading the cross functional study set up activities for successful conduct of the study, with guidance from the clinical development lead physician. Assisting and/or lead drafting responses to regulatory agencies, IRB/EC, and study sites related to the study protocol, and ensure timely response to these requests. Performing periodic ongoing clinical data review from various EDC systems, contributing to the interpretation of results and providing actionable insights for study progression and decision-making. Preparing and reviewing clinical study reports, regulatory submissions, and manuscripts for scientific publication, ensuring accuracy and compliance. Interacting with regulatory agencies to support clinical trial applications and maintain compliance with regulatory standards. Staying abreast of advancements in oncology and cell therapy, integrating new findings into clinical strategies and practices. Providing guidance and mentorship to junior staff on best practices in clinical research and trial management. Requirements: Advanced degree in a relevant scientific discipline (e.g., oncology, immunology, cell biology, or nursing): Ph.D./MD/PharmD with 8-12+ years of experience, or M.S. with 12-15+ years of experience. Minimum of 5 years of experience in clinical research (i.e. performing study design, set up, and clinical data review) Experience in the following areas are preferred oncology, rheumatology/autoimmune disease, and cell therapy (allogenic or autologous) Regulatory submission experience is a plus Benefits: Pre-IPO stock options Health benefits (medical, dental, and vision) Competitive salary with comprehensive benefits and PTO 401K contribution Collaboration with biopharmaceutical partners and worldwide academic institutes worldwide

Associate Director, Clinical Science

Job Type: Full-time Salary: $160,000 - $200,000 Location: Alameda, CA Company Summary: As private equity and VC backed clinical-stage biotech company, their mission is to develop a safe, effective, and affordable first-in-class cell therapy pipeline to treat cancer. To achieve this, they are focused on developing gamma delta T cell therapies with a patented ACC platform that targets immune cells. The Opportunity: The Associate Director, Clinical Science will play a critical role in the design, implementation, and analysis of clinical trials focused on our advance cell therapy programs. Reporting to the Executive Director of Clinical Development, this person will be responsible for collaborating cross-functionally to ensure completion of the clinical studies. Responsibilities: Developing and overseeing clinical trial protocols to ensure alignment with regulatory guidelines and strategic objectives. Leading the cross functional study set up activities for successful conduct of the study, with guidance from the clinical development lead physician. Assisting and/or lead drafting responses to regulatory agencies, IRB/EC, and study sites related to the study protocol, and ensure timely response to these requests. Performing periodic ongoing clinical data review from various EDC systems, contributing to the interpretation of results and providing actionable insights for study progression and decision-making. Preparing and reviewing clinical study reports, regulatory submissions, and manuscripts for scientific publication, ensuring accuracy and compliance. Interacting with regulatory agencies to support clinical trial applications and maintain compliance with regulatory standards. Staying abreast of advancements in oncology and cell therapy, integrating new findings into clinical strategies and practices. Providing guidance and mentorship to junior staff on best practices in clinical research and trial management. Requirements: Advanced degree in a relevant scientific discipline (e.g., oncology, immunology, cell biology, or nursing): Ph.D./MD/PharmD with 8-12+ years of experience, or M.S. with 12-15+ years of experience. Minimum of 5 years of experience in clinical research (i.e. performing study design, set up, and clinical data review) Experience in the following areas are preferred oncology, rheumatology/autoimmune disease, and cell therapy (allogenic or autologous) Regulatory submission experience is a plus Benefits: Pre-IPO stock options Health benefits (medical, dental, and vision) Competitive salary with comprehensive benefits and PTO 401K contribution Collaboration with biopharmaceutical partners and worldwide academic institutes worldwide

Associate Director, Clinical Science

Job Type: Full-time Salary: $160,000 - $200,000 Location: Alameda, CA Company Summary: As private equity and VC backed clinical-stage biotech company, their mission is to develop a safe, effective, and affordable first-in-class cell therapy pipeline to treat cancer. To achieve this, they are focused on developing gamma delta T cell therapies with a patented ACC platform that targets immune cells. The Opportunity: The Associate Director, Clinical Science will play a critical role in the design, implementation, and analysis of clinical trials focused on our advance cell therapy programs. Reporting to the Executive Director of Clinical Development, this person will be responsible for collaborating cross-functionally to ensure completion of the clinical studies. Responsibilities: Developing and overseeing clinical trial protocols to ensure alignment with regulatory guidelines and strategic objectives. Leading the cross functional study set up activities for successful conduct of the study, with guidance from the clinical development lead physician. Assisting and/or lead drafting responses to regulatory agencies, IRB/EC, and study sites related to the study protocol, and ensure timely response to these requests. Performing periodic ongoing clinical data review from various EDC systems, contributing to the interpretation of results and providing actionable insights for study progression and decision-making. Preparing and reviewing clinical study reports, regulatory submissions, and manuscripts for scientific publication, ensuring accuracy and compliance. Interacting with regulatory agencies to support clinical trial applications and maintain compliance with regulatory standards. Staying abreast of advancements in oncology and cell therapy, integrating new findings into clinical strategies and practices. Providing guidance and mentorship to junior staff on best practices in clinical research and trial management. Requirements: Advanced degree in a relevant scientific discipline (e.g., oncology, immunology, cell biology, or nursing): Ph.D./MD/PharmD with 8-12+ years of experience, or M.S. with 12-15+ years of experience. Minimum of 5 years of experience in clinical research (i.e. performing study design, set up, and clinical data review) Experience in the following areas are preferred oncology, rheumatology/autoimmune disease, and cell therapy (allogenic or autologous) Regulatory submission experience is a plus Benefits: Pre-IPO stock options Health benefits (medical, dental, and vision) Competitive salary with comprehensive benefits and PTO 401K contribution Collaboration with biopharmaceutical partners and worldwide academic institutes worldwide