Associate Director, Clincal Operations
Associate Director, Clinical Operations San Diego, CA - Hybrid $150,000 - $180,000 A clinical-stage biotechnology company in San Diego is dedicated to developing transformative medicines for patients with life-threatening diseases. This company focuses on precision medicine, leveraging advanced technologies to create innovative therapies that address significant unmet medical needs. With a robust pipeline targeting various cancer types and other serious conditions, the company is at the forefront of developing next-generation treatments. Supported by a strong leadership team with extensive industry experience and significant funding from top-tier investors, the company is well-positioned for rapid growth and success in the biotech industry. Joining this team means being part of a passionate group committed to making a tangible difference in patients' lives. Responsibilities: Oversee the planning, execution, and management of clinical trials, ensuring compliance with regulatory requirements and company standards Manage relationships with CROs and other vendors, including contract negotiations and performance monitoring Provide direction and support to clinical operations team members, fostering a collaborative and high-performance environment Ensure all clinical activities adhere to GCP, FDA, and other regulatory guidelines Develop and manage clinical trial budgets, ensuring cost-effective use of resources Identify potential risks and implement mitigation strategies to ensure the successful completion of clinical trials Ensure the accuracy and integrity of clinical trial data through rigorous monitoring and quality control processes Work closely with other departments, including clinical development, regulatory affairs, and data management, to achieve project goals Oversee the preparation and review of clinical trial documentation, including protocols, informed consent forms, and study reports Identify opportunities for process improvements and implement best practices in clinical operations Qualifications Bachelor's degree in a scientific or health-related field. At least 2 years of experience in clinical research, ideally within a biopharmaceutical or CRO setting. Knowledge of FDA regulations and ICH/GCP guidelines is essential. Strong organizational and multitasking skills, with the ability to work in a collaborative team environment. Excellent written and verbal communication skills. Problem-solving and negotiation abilities, with the ability to adapt as needed. Proficiency in Microsoft Office and experience with clinical trial management systems (e.g., Medidata Rave, InForm). This role offers the opportunity to contribute to groundbreaking therapies in a dynamic and innovative environment. If you are passionate about clinical operations and making a difference in patients' lives, we encourage you to apply.
US$150000 - US$170000 per year
San Diego
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Senior/Executive Director, Clinical Operations
Job Type: Full-time Salary: $275K - $325K Location: San Francisco Bay Area Company Summary: Clinical stage biotech developing a pipeline of first in class cell therapies to treat cancer and autoimmune disease. Currently they are backed by VCs and have successfully raised over a quarter million in funding to continue advancing their clinical programs. The Opportunity: The VP, Clin Ops will play a critical role in the designing and implementing clinical trial protocols to advance their early phase cell therapy programs. Reporting to the Chief Medical Officer, this person will be responsible for collaborating cross-functionally to ensure completion of the clinical studies in a timely manner. Responsibilities: Reporting into the CMO Providing critical leadership, oversight, and line management for early-stage oncology program ensuring that clinical trials are conducted in accordance with the protocols, timelines, and budgets Supporting cross functional development of departmental policies Developing and implementing study and program budgets, including CRO/vendor budgets and contracts with a planning horizon of 1-2 years Management of clinical trials and operations in one or more drug development programs Leading site and vendor selection processes, including, the selection of Contract Research Organizations (CROs) An ideal candidate for this role MUST haveโฆ 15+ years of biopharma INDUSTRY experience REQUIRED 8+ years of CRO trial management experience 5+ years of Associate Director/Director experience at a small biotech Demonstrated success identifying, negotiating and overseeing outsourced vendors A working knowledge of ICH GCP guidelines Benefits: Pre-IPO biotech company Competitive salary with comprehensive benefits (90% medical coverage) Flexible PTO and WFH arrangements 401K contribution Cell phone reimbursement, life insurance, and additional perks
US$285000 - US$325000 per year
San Francisco
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Clinical Research Associate (Clinical Specialist)
Salary: $95-115K Company Summary: A global, specialty pharmaceutical group with an impressive track record is seeking a motivated Clinical Research Associate for a hybrid role at their San Francisco site. Their commercial supply of pharmaceutical products generated $83m in revenue in FY2023 (a 24% uptick from the year prior). Since their first clinical trials in 2006, they've had 3 approvals already on the market. Currently, they have 6 indications in Phases II and III, so they are looking for a driven, growth-oriented Clinical Research Associate to facilitate their in house studies. The CRA will be responsible for: Managing and investigating clinical trials and/or post-authorization safety studies Performing and coordinating different aspects of clinical monitoring and site management 50-75% travel An ideal candidate for this role MUST haveโฆ 2+ years of ONSITE monitoring experience at a sponsor or CRO A Bachelor's degree in Biological Sciences, Nursing, Pharmacy or a related discipline A working knowledge of ICH GCP guidelines Benefits: Competitive salary with benefits High degree of commercial exposure early in your career Being a part of team whose work directly aims to improve the quality of people's lives Great work-life balance If you are interested in this Clinical Research Associate role, don't hesitate to reach out!
US$95000 - US$115000 per year
San Francisco
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Clinical Trial Manager
Clinical Trial Manager Salary: ($140,000 - $165,000) SF Bay Area (hybrid 3 days per week) This midsized biotech is oncology focused and they are ramping up for a global phase III. They're rapidly growing and are still privately held. In the past several years, they've raised close to $1B in funding and are looking for a Clinical Trial Manager to support their global phase III. Responsibilities: Oversee the management of international clinical trials, ensuring all aspects are handled efficiently. Develop and implement operational plans for oncology clinical trials. Work closely with cross-functional teams, including data management, clinical scientists, regulatory, and investigators, to ensure smooth operations and timely delivery of high-quality data. Manage trial start-up activities, including site selection, feasibility assessments, and preparation of study documentation. Requirements: 2+ years experience managing clinical trials (sponsor side) 3+ years oncology (sponsor side) 2+ years experience working in an in-house model, not outsourcing to CROs Ideally late phase expertise This company offers a competitive compensation package which includes: Annual bonus Pre-IPO equity package Health, vision, and dental insurance 401(k) match If you're interested in this role, please apply now.
US$140000 - US$165000 per year
Hayward
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Senior CTM
Senior Clinical Trial Manager Remote (USA) $160,000 - $190,000 A commercial stage biotech is developing innovative treatments for cancers. With a marketed product, 8 clinical drug candidates, and over 40 clinical trials globally, they are able to offer a blend of financial stability along with extensive opportuntiies for growth. They have signed strategic licensing agreements which add to the financial runway and market access for their commercial drug, and have a great leadership team in place. Responsibilities: Read and oversee the planning, initiation, and execution of clinical trials, ensuring adherence to protocols, regulatory requirements, and ethical standards. Effectively manage relationships with investigational sites, fostering collaboration, providing support, and addressing site-specific needs to optimize site performance throughout the trial. Implement robust data monitoring processes, conducting regular reviews and source data verification to ensure the accuracy and integrity of data collected in clinical trials. Ensure all aspects of clinical trials comply with relevant regulatory requirements and guidelines, collaborating with regulatory affairs to address any compliance-related issues and facilitate successful trial outcomes. Proactively identify potential risks associated with Oncology trials and develop strategic plans for risk mitigation. Address and resolve issues promptly to ensure the smooth progression of the trial and meet project timelines Qualifications: Proven track record with a significant duration of experience working specifically in the field of Autoimmunity within the pharmaceutical or biotech industry. In-depth knowledge of Oncology and Immunology clinical trials, including protocol design, patient recruitment, and monitoring, with a demonstrated ability to navigate the unique challenges associated with neurological disorders. Comprehensive understanding of regulatory requirements and guidelines, ensuring compliance with regulatory standards throughout the drug development process. Substantial experience in managing investigational sites, building and maintaining effective relationships, and optimizing site performance to ensure successful trial execution. Proficiency in overseeing data review processes, including source data verification and analysis, to ensure the accuracy and integrity of clinical trial data in the autoimmune therapeutic area. Benefits: Medical, dental, vision insurance 401(k) PTO and Holidays
US$160000 - US$190000 per year
Rockville
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Director, Clinical Operations
Director Clinical Operations New York City, New York (hybrid) $175,000 - $200,000 My client is a focused and growing company, dedicated to developing innovative therapies for neuropsychiatric diseases and improving outcomes for patients. They are building a pipeline that leverages the broad therapeutic potential of its lead product candidate for the treatment of schizophrenia and other neuropsychiatric diseases. With tried and true leadership and very positive data, it's an exciting time to get a foot in the door with them. Responsibilities Accountability for the overall management of assigned clinical programs (across multiple studies), including providing strategic direction to study teams to ensure timely clinical trial execution. Maintaining inspection-readiness across clinical programs. Assistance in development of hiring/resourcing plans and program budgets. Assist in the hiring process to build out the study team. Day-to-day management of assigned direct reports. Mentorship and oversight of junior team members. Oversight of clinical research organizations (CROs) and other key vendors to ensure timely and quality deliverables. Act as a point of escalation for clinical trial execution issues. Lead preparation of vendor requirements and project scope and selection of study vendors. Contribution to the establishment of KPIs to measure vendor performance. Implementation of appropriate systems, standards, and processes to ensure quality at the level of investigative sites, vendors, and data. Oversight of the clinical aspects of timely data cleaning, data analysis and the availability of top line results. Oversight of the set-up and implementation of effective investigator and site monitor training; facilitation of operational and therapeutic area training for internal and external study team members. Review of study invoices and participation in accrual reviews to track the financial status of the study against budget. Establishment of clinical operations SOPs, Work Instructions, guidelines, standards, and best practices. Leadership and implementation of infrastructure initiatives, process improvements, change management, and ad-hoc business projects. Demonstrated understanding of the clinical program oversight, including monitoring of data, review of TLF, implementation and working of IRT, EDC development, vendor oversight. Qualifications Bachelors degree required and Masters degree preferred. Some prior experience in a medical field, such as nursing or pharmacy. 12+ years of experience working with CROs to manage large global clinical trials. CNS disease experience is a plus. 4+ years of experienced in managing direct reports, evidencing strong leadership, team-building, and hands-on management. Experience monitoring all types of data Comprehensive understanding of ICH and GCP guidelines, as well as applicable regulations and practices. Excellent organizational skills and attention to detail. Effective communication and interpersonal skills. Able to set priorities, juggle multiple demands, and manage changing priorities. Able to think critically and be a proactive problem-solver. Able to work independently while exercising initiative, flexibility, and sound judgment. Comfortable working with different levels of the company including senior level management. Ability to travel approximately 30% Ability to operate in alignment with company values and culture. Benefits Company benefits include a comprehensive medical plan, 401K participation, three weeks of vacation, and a steeply discounted Lifetime gym membership. This is a dynamic and supportive work environment offering a competitive benefits package, as well as the opportunity to become a shareholder in the Company and participate in its future success.
US$175000 - US$200000 per year
New York
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Director of Clinical Operations
Job Title: Director of Clinical Operations Location: Boston, Massachusetts Salary: $240,000-$255,000 Job Summary: The Director of Clinical Operations will lead and oversee all clinical trial activities for their inflammation and immunology programs. This role is critical in ensuring the successful execution of clinical trials, from early-phase studies through to late-stage development. The Director will work closely with cross-functional teams, including clinical research, regulatory affairs, and data management, to drive the development of innovative therapies. At this time in development we are heavily in phase 1/2 trials with an in-sourced model. Key Responsibilities: Leadership and Strategy: Develop and implement clinical operations strategies to support the company's I&I pipeline. Provide leadership and direction to the clinical operations team, ensuring alignment with corporate goals and objectives. Oversee the planning, execution, and management of clinical trials, ensuring they are conducted in compliance with regulatory requirements and Good Clinical Practice (GCP). Trial Management: Manage all aspects of clinical trials, including site selection, patient recruitment, data collection, and monitoring. Ensure timely and accurate reporting of trial progress and results to senior management and stakeholders. Develop and manage clinical trial budgets, timelines, and resources. Regulatory Compliance: Ensure all clinical trial activities are conducted in accordance with regulatory requirements and company SOPs. Prepare and submit regulatory documents to ethics committees and regulatory authorities. Team Leadership and Development: Lead, mentor, and develop the clinical operations team, fostering a collaborative and high-performance culture. Provide training and support to team members to ensure continuous professional development. Cross-Functional Collaboration: Collaborate with cross-functional teams, including clinical research, regulatory affairs, data management, and biostatistics, to ensure the successful execution of clinical trials. Act as a key liaison between the clinical operations team and other departments within the company. Qualifications: Previous in-house experience at a small/midsize biotech. Minimum of 10 years of experience in clinical trial management, with at least 5 years in a leadership role. Minimum 10 years of inflammation/autoimmune therapeutic area and clinical development processes. Excellent organizational, communication, and leadership skills. Proven ability to manage multiple projects and priorities simultaneously. Preferred Qualifications: Experience in early-phase oncology trials. Experience with in-house model. Benefits: Competitive benefits package (401k match, medical health care 100% covered, PTO). Stock/equity options.
US$240000 - US$255000 per year
Boston
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Clinical Trial Manager/Senior Manager
Location: Seoul, Korea Therapeutic Areas: Cardiovascular, Infectious Disease, CNS/Neuroscience An award-winning global Clinical Research Organisation with international reputation in providing Phase 1 to Phase IV clinical development services is looking for a Clinical Trial Manager to be based in South Korea. This opportunity provides amazing growth potential, career progression and the chance to be working with a growing company. Responsibilities: Lead projects for multi-service global clinical trials Manage project timelines and deliverables Lead cross functional teams - clinical monitoring, study start-up, regulatory, contract, safety, medical monitoring. Secure new businesses Requirements: Bachelor's degree (Masters or PhD preferred) Relevant experience in clinical trial management in Asia, in a CRO is preferred Good communication skills and team spirit If you are interested, please apply with your CV attached.
Negotiable
Seoul
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Director of Clinical Operations
Job Title: Director of Clinical Operations Location: Boston, Massachussets Department: Clinical Operations Reports to: Vice President of Clinical Development Job Summary: The Director of Clinical Operations will lead and oversee all clinical trial activities for oncology programs. This role is critical in ensuring the successful execution of clinical trials, from early-phase studies through to late-stage development. The Director will work closely with cross-functional teams, including clinical research, regulatory affairs, and data management, to drive the development of innovative cancer therapies. Key Responsibilities: Leadership and Strategy: Develop and implement clinical operations strategies to support the company's oncology pipeline. Provide leadership and direction to the clinical operations team, ensuring alignment with corporate goals and objectives. Oversee the planning, execution, and management of clinical trials, ensuring they are conducted in compliance with regulatory requirements and Good Clinical Practice (GCP). Trial Management: Manage all aspects of clinical trials, including site selection, patient recruitment, data collection, and monitoring. Ensure timely and accurate reporting of trial progress and results to senior management and stakeholders. Develop and manage clinical trial budgets, timelines, and resources. Vendor and CRO Management: Select and manage Contract Research Organizations (CROs) and other vendors. Monitor vendor performance to ensure quality and compliance with contractual obligations. Regulatory Compliance: Ensure all clinical trial activities are conducted in accordance with regulatory requirements and company SOPs. Prepare and submit regulatory documents to ethics committees and regulatory authorities. Team Leadership and Development: Lead, mentor, and develop the clinical operations team, fostering a collaborative and high-performance culture. Provide training and support to team members to ensure continuous professional development. Cross-Functional Collaboration: Collaborate with cross-functional teams, including clinical research, regulatory affairs, data management, and biostatistics, to ensure the successful execution of clinical trials. Act as a key liaison between the clinical operations team and other departments within the company. Qualifications: Advanced degree in life sciences, nursing, or a related field (PhD, MD, or equivalent preferred). Minimum of 10 years of experience in clinical trial management, with at least 5 years in a leadership role. Minimum 10 years of oncology therapeutic area and clinical development processes. Excellent organizational, communication, and leadership skills. Proven ability to manage multiple projects and priorities simultaneously. Preferred Qualifications: Experience in early-phase oncology trials. Experience with in-house model. Benefits: Competitive benefits package (401k match, medical health care 100% covered, PTO). Pre-IPO equity options.
US$180000 - US$220000 per year
Boston
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Director CDM
Director Clinical Data Management San Diego, CA - Hybrid 200,000-286,000 A clinical-stage cell therapy company in San Diego is expanding its clinical data management team. Specializing in treatments for autoimmune diseases, the company employs a novel approach by utilizing Natural Killer (NK) cells that specifically target B cells. These NK cells are engineered as "off-the-shelf" therapy, meaning they are pre-produced rather than sourced from a patient's own cells, enhancing accessibility and scalability. As pioneers in cell therapies, the team made one of the first IND filings for Lupus using cell therapy. Currently, they are advancing six indications, with four in clinical stages. The company is focused on streamlining manufacturing and distribution to improve access to innovative treatments. The CEO has over 20 years of experience in biotech and venture capital, with leadership roles in prominent life sciences companies, while the CMO has a strong background in clinical research from leading pharmaceutical firms. This role offers the chance to contribute to the ongoing development of therapies at the intersection of cell therapy and auto-immunology. Key Responsibilities * Support the management of clinical trial activities to ensure studies are completed on time, within budget, and in compliance with regulatory standards, standard operating procedures (SOPs), and ICH/GCP guidelines. * Help oversee essential trial aspects, including study start-up, patient enrollment, site interactions, and data management, proactively identifying and resolving issues. * Draft and review key study documents, including informed consent forms, case report forms, study manuals, and other trial materials. * Assist in selecting and managing study sites and evaluating CROs and other service providers, as well as overseeing contracts and budgets. * Work towards project goals, managing timelines and deliverables to align with organizational objectives. * Provide study updates to cross-functional teams and help address issues with sites and CROs through analysis and action planning. * Contribute to the development of study tools and resources to enhance data quality and trial efficiency. * Participate in training new team members on study processes as needed. * Track study progress, maintain relevant metrics, and keep the team informed. * Serve as a key point of contact for study sites, and participate in assessing and resolving any safety or patient care issues. * Oversee and support contract and budget negotiations with clinical sites. * Assist in planning and presenting at investigator and CRO training meetings. * Conduct site visits as needed, including qualification, initiation, monitoring, and close-out visits; perform oversight visits to review and assess CRO activities. * Support internal and external audits, helping to address and resolve any findings. Qualifications and Experience * Bachelor's degree in a scientific or health-related field. * At least 2 years of experience in clinical research, ideally within a biopharmaceutical or CRO setting. * Oncology or autoimmune trial experience is highly preferred; early-phase development experience is beneficial. If you are interested, dont hesitate to apply.
US$200000 - US$286000 per year
San Diego
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Associate CTM
Associate Clinical Trial Manager San Francisco Bay Area Salary: $120,000-$145,000 A well-funded Bay Area radio-pharma biotech company is looking to add on to their clinical operations team. This company is reimagining the future of cancer treatment through innovative radiotherapeutics, and you can contribute to transform the treatment of cancer entirely. They're developing a novel precision medicine approach aimed at transforming patient outcomes in oncology though a best-in-class radiotherapy that selectively destroys tumor cells while sparing healthy cells. The leadership team at this company is poised to make it a standout in radiotherapies. Their CEO has 20+ years in life sciences and most recently secured $500M in Series A funding for a precision neurology biotech. The CMO brings experience from some of the most successful pharmaceutical companies in the world. They've had their first IND submission this year, with 5 additional cancer targets in their pipeline. They have already raised $140 Million in funding, and are operating in the highly innovative radio-therapy space. Key Responsibilities * Support the management of clinical trial activities to ensure studies are completed on time, within budget, and in compliance with regulatory standards, standard operating procedures (SOPs), and ICH/GCP guidelines. * Help oversee essential trial aspects, including study start-up, patient enrollment, site interactions, and data management, proactively identifying and resolving issues. * Draft and review key study documents, including informed consent forms, case report forms, study manuals, and other trial materials. * Assist in selecting and managing study sites and evaluating CROs and other service providers, as well as overseeing contracts and budgets. * Work towards project goals, managing timelines and deliverables to align with organizational objectives. * Provide study updates to cross-functional teams and help address issues with sites and CROs through analysis and action planning. * Contribute to the development of study tools and resources to enhance data quality and trial efficiency. * Participate in training new team members on study processes as needed. * Track study progress, maintain relevant metrics, and keep the team informed. * Serve as a key point of contact for study sites, and participate in assessing and resolving any safety or patient care issues. * Oversee and support contract and budget negotiations with clinical sites. * Assist in planning and presenting at investigator and CRO training meetings. * Conduct site visits as needed, including qualification, initiation, monitoring, and close-out visits; perform oversight visits to review and assess CRO activities. * Support internal and external audits, helping to address and resolve any findings. Qualifications and Experience * Bachelor's degree in a scientific or health-related field. * At least 2 years of experience in clinical research, ideally within a biopharmaceutical or CRO setting. * Oncology trial experience is highly preferred; early-phase development experience is beneficial. * Knowledge of FDA regulations and ICH/GCP guidelines is essential. * Strong organizational and multitasking skills, with the ability to work in a collaborative team environment. * Excellent written and verbal communication skills. * Problem-solving and negotiation abilities, with the ability to adapt as needed. * Proficiency in Microsoft Office and experience with clinical trial management systems (e.g., Medidata Rave, InForm).
US$120000 - US$145000 per year
San Francisco
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