Director / Sr. Director, Clinical Operations
Salary: $210K-250K Company Summary: A global immuno-oncology focused biotech with an impressive track record is seeking a Director or Sr. Director of Clinical Operations for a hybrid (3 days on site) role located in South San Francisco, CA. Since their first clinical trials in 2006, they've had 3 approvals already on the market. Currently, they have 8 indications in Phases II and III, so they are looking for a driven, growth-oriented Director/SD to head up their late phase IO studies. The Director/Sr. Director, Clin Ops will be responsible for: Managing CTMs to ensure timely execution of Phase 3 studies Supervising study programs as well as participating in the preparation of study budgets and contract negotiations Contributing to cross functional development of departmental policies Overseeing vendors in conjunction with study managers Periodic travel (< 20%) An ideal candidate for this role MUST haveโฆ 7+ years of biopharma INDUSTRY experience 6+ years of senior management experience - IO or complex trial experience PREFERRED 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 (90% Medical HMO Coverage) 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 Director/Sr. Director of Clin Ops position, drop a CV!
US$215000 - US$250000 per year
San Francisco
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Senior Clinical Trial Manager
Senior Clinical Trial Manager San Diego, CA (Hybrid) $160,000 - $180,000 Job Description EPM is partnered with a trailblazing biotech nestled in sunny San Diego, dedicated to pioneering breakthroughs at the intersection of oncology and immunology. Leveraging cutting-edge research and innovative technologies, they're committed to developing targeted therapies that harness the power of the immune system to combat cancer. With a passionate team of experts and a relentless drive for innovation, they are revolutionizing cancer treatment and bringing hope to patients worldwide. Key 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. Roles & Responsibilities Lead 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. Benefits Medical, dental, vision insurance 401(k) PTO and Holidays
US$160000 - US$180000 per year
United States of America
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Director Clinical Operations
Salary: $200,000-$220,000 Director Clinical Operations Boston, MA (Hybrid) Job Description A pioneering Biotech in the heart of Boston, dedicated to revolutionizing autoimmune disease treatment is looking to bring on a Director of Clinical Operations. By leveraging cutting-edge research and breakthrough technologies, they specialize in developing targeted therapies to restore harmony within the immune system. Their team of top scientists and clinicians is committed to delivering precise, effective solutions for patients battling autoimmune conditions. Join them in their mission to redefine healthcare and transform lives through innovation and compassion. Key Qualifications Bachelors degree in a Life Sciences related field Expansive knowledge of clinical operations, clinical project management related to GCP, ICH, and SOP guidelines Ability to work independently as well as collaboratively and has experience working with cross functional stakeholders 10+ years overseeing complex clinical trials at a biotech or pharmaceutical company Experience working on late phase autoimmune indications highly preferred Roles & Responsibilities Develop and implement strategic plans for clinical trials in alignment with the company's overall objectives and regulatory requirements. Ensure the effective management of CROs (Contract Research Organizations), vendors, and other external partners involved in clinical trial activities. Foster effective communication and collaboration among internal teams and external stakeholders, including investigators, site personnel, and regulatory authorities. Represent the company in interactions with regulatory agencies, ensuring clear and timely communication of clinical trial progress and results. Establish and maintain high-quality standards for clinical trial conduct in accordance with Good Clinical Practice (GCP) guidelines, regulatory requirements, and internal standard operating procedures. Benefits Medical, dental, vision insurance 401(k) PTO and Holidays
US$200000 - US$220000 per year
United States of America
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Senior Clinical Research Associate (SCRA)
Salary: $120-139K Company Summary: Working with a precision IO biotechnology company to build out their clinical operations team and they are currently looking for a Sr. Clinical Research Associate (SCRA) on a hybrid capacity in their SF office. Their mission is to develop best-in-class immunotherapies to address unmet needs within the oncology and their pipeline consists of 1 Phase I asset and 4 more preclinical assets and the Director/Senior Director will be a key leader in the oversight and management of their oncology program, focusing primarily on their Phase I FIH study which is currently recruiting. The Sr. CRA will be responsible for: Supporting study operational activities under the direction of the clinical study lead Assisting with trial related tasks including oversight and management of CROs and other study vendors Providing support to ensure that studies are completed on time, within budget, and in compliance with SOPs and applicable regulatory requirements Maintaining study registries and dashboards Approx. 20% travel depending on study/project needs An ideal candidate for this role MUST haveโฆ 4 years of industry experience REQUIRED 2 years oncology experience Global trial experience preferred A Bachelor's degree in Biological Sciences, Nursing, Pharmacy or a related discipline 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 If you are interested in this Sr. CRA role, don't hesitate to reach out!
US$121000 - US$139000 per year
San Francisco
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Associate Director Clinical GCP Quality
Our client is an industry-leading biotechnology company that specializes in developing groundbreaking cancer therapies that harness the power of cutting-edge technologies. They are currently seeking a highly experienced professional to join their team as the Associate Director of Clinical (GCP) Quality. Responsibilities: Proven track record in effectively managing and supervising CAPA plans, including writing, reviewing, approving, and closing them. Demonstrated capability in conducting and overseeing site, internal GCP, and vendor audits, along with directing and guiding audit follow-up actions. Proficiency in establishing Quality and Cross-Functional Standard Operating Procedures (SOPs) and processes, along with implementing associated document controls. Experience serving as a global document management system administrator. Skilled in managing and mentoring direct reports. Ability to coordinate cross-functional meetings between departments and Quality teams. Willingness to undertake other duties as assigned. Qualifications: Bachelor's degree or higher qualification within life sciences At least 10 years' experience working in GCP Quality Assurance and/or GCP Compliance, additional GCP Auditing experience preferred In-depth knowledge of global regulations related to good clinical practice Excellent interpersonal communication skills along with proficiency communicating both verbally and written formats. Bilingual Willingness to travel If you are interested, please apply with your CV attached.
Negotiable
Tokyo
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Clinical Study Lead
Our client, a leading biotech company based in Japan is seeking to hire someone with expertise in this field. As the Clinical Study Lead, you will be responsible for overseeing and managing all aspects of clinical studies related to their products. Responsibilities: Plan and execute various phases of clinical trials Ensure compliance with regulatory requirements Manage budgets, timelines and resource allocation Collaborate with cross-functional teams including medical affairs, research & development etc. Qualifications: To qualify as our ideal candidate you should possess; Relevant academic qualifications e.g Medical Device or Healthcare-related degree programs Demonstrated experience having managed multiple global/ regional phase II/III clinical trial projects within Oncology therapeutic area(s). Strong communication skills both verbal and written; fluency in English required; Japanese language proficiency preferred but not mandatory. If you are interested, please apply with your CV attached
Negotiable
Tokyo
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Clinical Trial Manager/Senior Manager
Location: Seoul, Korea Therapeutic Areas: Oncology, 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 Taiwan. 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 Preferably a tertiary education in law and/or experience within the Chinese legal jurisdiction Good communication skills and team spirit If you are interested, please apply with your CV attached.
Negotiable
Seoul
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Senior Clinical Trial Manager
Senior Clinical Trial Manager San Diego, CA (Hybrid) $160,000 - $180,000 Job Description EPM is partnered with a trailblazing biotech nestled in sunny San Diego, dedicated to pioneering breakthroughs at the intersection of oncology and immunology. Leveraging cutting-edge research and innovative technologies, they're committed to developing targeted therapies that harness the power of the immune system to combat cancer. With a passionate team of experts and a relentless drive for innovation, they are revolutionizing cancer treatment and bringing hope to patients worldwide. Key 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. Roles & Responsibilities Lead 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. Benefits Medical, dental, vision insurance 401(k) PTO and Holidays
Negotiable
United States of America
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Associate Director / Director, Clinical Operations
Salary: $185K-210K Company Summary: A global immunology focused pharmaceutical group with an impressive track record is seeking an Associate Director of Clinical Operations for a hybrid role located in Palo Alto, CA. 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 Senior Clinical Trial Manager to head up their Phase III studies. The Associate Director will be responsible for: Managing CTMs to ensure timely execution of Phase 3 studies Supervising study programs as well as participating in the preparation of study budgets and contract negotiations Contributing to cross functional development of departmental policies Overseeing vendors in conjunction with study managers Periodic travel (< 20%) An ideal candidate for this role MUST haveโฆ 7+ years of biopharma INDUSTRY experience 6+ years of senior management experience - rare disease / autoimmune / immunology therapeutic experience greatly PREFERRED 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 (100% Medical HMO Coverage) 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 Associate Director/Director role, don't hesitate to reach out!
US$185000 - US$210000 per year
San Francisco
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Associate Director / Director, Clinical Operations
Salary: $185K-210K Company Summary: A global immunology focused pharmaceutical group with an impressive track record is seeking an Associate Director of Clinical Operations for a hybrid role located in Palo Alto, CA. 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 Senior Clinical Trial Manager to head up their Phase III studies. The Associate Director will be responsible for: Managing CTMs to ensure timely execution of Phase 3 studies Supervising study programs as well as participating in the preparation of study budgets and contract negotiations Contributing to cross functional development of departmental policies Overseeing vendors in conjunction with study managers Periodic travel (< 20%) An ideal candidate for this role MUST haveโฆ 7+ years of biopharma INDUSTRY experience 6+ years of senior management experience - rare disease / autoimmune / immunology therapeutic experience greatly PREFERRED 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 (100% Medical HMO Coverage) 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 Associate Director/Director role, don't hesitate to reach out!
US$185000 - US$210000 per year
San Francisco
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Clinical Trial Manager / Sr. Clinical Trial Manager
Salary: $140-190K Company Summary: Working with a clinical-stage biotech company that's looking for a Clinical Trial Manager or Sr. Clinical Trial Manager to come into their South SF office on a hybrid/full-time basis. Their mission is to create a best-in-class immunotherapies that address unmet needs within oncology and their pipeline consists of 2 Phase II assets, 1 Phase I asset and 6 more preclinical assets. The CTM/SCTM will play a pivotal role in the oversight and management of their oncology studies. The CTM/Sr. CTM will be responsible for: * Reporting directly into the Director, Clinicial Operations * Managing Phase 2 global oncology trials ensuring they are conducted in accordance with protocols, timelines, and budgets * Assisting in the management of key study-related activities and deliverables * Coordinating and contributing to the design of study materials and protocols * Conducting (co)monitoring visits (pre-study, initiation, monitoring, and closeout) with CRO An ideal candidate for this role MUST haveโฆ * 5+ years of biopharma INDUSTRY experience REQUIRED * 3 years of trial management experience REQUIRED * A working knowledge of ICH GCP guidelines * An undergraduate degree in a relevant field of study Benefits: * Pre-IPO biotech company with good runway * Competitive salary with comprehensive benefits (85% medical coverage) * Flexible PTO arrangements * 401K contribution If you are interested in this CTM/SCTM position, don't hesitate to reach out!
US$140000 - US$190000 per year
San Francisco
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Clinical Trial Manager / Sr. Clinical Trial Manager
Salary: $140-190K Company Summary: Working with a clinical-stage biotech company that's looking for a Clinical Trial Manager or Sr. Clinical Trial Manager to come into their South SF office on a hybrid/full-time basis. Their mission is to create a best-in-class immunotherapies that address unmet needs within oncology and their pipeline consists of 2 Phase II assets, 1 Phase I asset and 6 more preclinical assets. The CTM/SCTM will play a pivotal role in the oversight and management of their oncology studies. The CTM/Sr. CTM will be responsible for: * Reporting directly into the Director, Clinicial Operations * Managing Phase 2 global oncology trials ensuring they are conducted in accordance with protocols, timelines, and budgets * Assisting in the management of key study-related activities and deliverables * Coordinating and contributing to the design of study materials and protocols * Conducting (co)monitoring visits (pre-study, initiation, monitoring, and closeout) with CRO An ideal candidate for this role MUST haveโฆ * 5+ years of biopharma INDUSTRY experience REQUIRED * 3 years of trial management experience REQUIRED * A working knowledge of ICH GCP guidelines * An undergraduate degree in a relevant field of study Benefits: * Pre-IPO biotech company with good runway * Competitive salary with comprehensive benefits (85% medical coverage) * Flexible PTO arrangements * 401K contribution If you are interested in this CTM/SCTM position, don't hesitate to reach out!
US$140000 - US$190000 per year
San Francisco
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