Clinical Program Manager, APAC
Salary: $145-165K Company Summary: One of the best funded pre-IPO biotechs with upwards of half a billion in funding is growing their clinical operations team as they continue to expand their oncology trials on a global scale. With an office in Hayward, they have Nobel prize winning science and experienced former Big Pharma C-suites executives at the helm to back it. Their pipeline has 7 programs in development across 12 indications and their lead candidate is heading into Phase 3. The best fit for this role will be a team leader who has APAC trial management experience and the ability to communicate in a language relevant to the region (Korean or Japanese). ***** Candidate must be able to go on-site in Hayward, CA three times a week.**** The Clinical Program Lead will be responsible for Reporting into the Sr. Director or Director of Clinical Operations and working in collaboration with Clinical Ops and Clinical R&D teams. Leading and managing Clinical Ops Study Management team and providing direction to cross-functional study teams to ensure successful study execution. Ensuring the design, monitoring, data interpretation and reporting activities related to the conduct of clinical studies are conducted in accordance with applicable regulations, ICH/GCP, APAC, PMDA, regulations and Standard Operating Procedures (SOPs). Managing ancillary (non CRO) vendor relationships and performance. Providing updates on study to internal stakeholders. Ensuring accurate and complete filing within clinical/reg/finance/safety systems. Complying with internal processes, SOPs, clinical & insurance supply management, and import/export requirements. A candidate for this role MUST haveโฆ Working fluency in Korean or Japanese and English 8+ years of experience establishing a clinical program and/or managing clinical trials in APAC region 5+ years of sponsor experience 3+ years of recent oncology or immunology experience 2+ of experience managing direct reports PhD, Master's Degree, or a Bachelor's Degree in life sciences, healthcare, or related field preferred. Benefits: Working with a world class leadership team including a former CMO responsible for a blockbuster dru Nobel Prize winning science Generous PTO and holiday policies PLUS one-week summer and winter shutdowns Daily subsidized lunch program when on site 401K + stock Medical, Dental, & Vision and more! If you are interested in this Clinical Program Manager role, feel free to reach out!
US$145000 - US$170000 per year
San Francisco
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Clinical Study Lead
Salary: $140-160K Company Summary: A global, specialty pharmaceutical group with an impressive track record is seeking a motivated Clinical Study Lead for a hybrid role in San Francisco (Palo Alto). Their commercial supply of pharmaceutical products generated $83m in revenue in FY2023 (a 24% uptick from the year prior during a year of record layoffs). 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 Study Lead to drive their pipeline forward. ***** Candidate must be based in SF to be considered.***** The Clinical Study Lead will be responsible for: In house study management of studies within their Vitiligo program Leading the cross-functional study team responsible for study delivery and oversight (as required) for the assigned study Overseeing the set-up and maintenance of study systems which may include Clinical Trial Management System (CTMS), Trial Master File (TMF), study SharePoint etc. May be responsible for CRA and CTAs as direct reports Reporting into the Clinical Program Lead An ideal candidate for this role MUST haveโฆ 5+ years sponsor experience 2+ years experience managing studies or trials in house (rare disease or derm preferred) At least 2 years of experience managing direct reports or mentoring junior clin ops tem members 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 Study Lead role, don't hesitate to reach out!
US$140000 - US$160000 per year
San Francisco
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VP Clinical Operations
Vice President Clinical Operations Boston, MA (Hybrid) $265,000 - $300,000 Job Description A pioneering precision medicine enterprise, based in the Boston area, is actively seeking a Vice President of Clinical Operations to join its esteemed team. Renowned for leadership in targeted oncology, the company is dedicated to reshaping the landscape of cancer care. Utilizing state-of-the-art technologies, they tailor treatments to meet the unique needs of individual patients. Embracing a collaborative culture, the company fosters innovation, providing an opportunity for professionals to contribute to groundbreaking advancements in precision oncology. The VP of Clinical Operations will hold a pivotal role in steering the evolution of healthcare, leaving a lasting impact on the lives of cancer patients. Responsibilities Strategic guidance and leadership provided to the clinical operations team for clinical trial management and execution Manage vendor selection and ensures compliance with established timelines and financial commitments Ensure cost, quality, and timeliness of multiple therapeutic programs Oversee recruitment, development, and retention of the clinical operations team, prioritizing activities in line with development programs Establish department standards, ensuring regulatory compliance Collaborates cross-functionally with Clinical, Product Development, Biostatistics, regulatory Affairs, Informatics, Legal, and Finance departments Qualifications Minimum of 10 year progressively responsible experience in clinical drug development Minimum of 8 years in a clinical operations management role 12 years of professional experience in pharmaceutical, biotech, CRO environments Hands on clinical operations leadership across all clinical development phases Demonstrated leadership in managing, coaching, and mentoring direct reports Excellent planning, organization, and time management skills, including prioritizing multiple projects Benefits 401(k) with percentage match Medical, Dental, Vision Performance and target based bonuses PTO and Holidays
US$265000 - US$300000 per year
United States of America
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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 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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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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Study Start-Up Specialist
Study Start-Up Specialist New Jersey (Hybrid) $90,000-$100,000 Job Description EPM is partnered with a company focused on creating novel therapeutic bi-specific, multi specific, and ADC's for cancer treatment. With their clinical stage assets, the data has been described as "the best I've ever seen" by industry leaders, and they signed a licensing agreement with a big pharma company at the end of last year worth multiple billion dollars. Given their science and financial backing along with the opportunity for growth, it's a really high potential opportunity. They're growing out a new office in New Jersey, so it's a very exciting time to join! Roles and Responsibilities Prepare, compile, and submit regulatory documents and applications required for the initiation of clinical trials (e.g., IND applications) Collaborate with clinical operations and project management teams to identify potential investigational sites for clinical trials Facilitate contract and budget negotiations with investigational sties and vendors Ensure all study-related documents are prepared according to regulatory requirements and company standards Key Qualifications At least 2 years of experience in a study start up focused role at a biotech or pharmaceutical company Experience in developing and maintaining project timelines and coordination cross-functional teams Familiarity with clinical trial protocols, informed consent processes, and study documentation preparation Ability to effectively communicate with internal teams, investigational sites, CRO's, and vendors High level of attention to detail to ensure accuracy and compliance in preparing regulatory documents and study materials Benefits Medical Dental Vision 401(k)
US$90000 - US$100000 per year
United States of America
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Associate Director Program Management
Associate Director Program Management Salary: ($140,000-$185,000) San Francisco Bay Area (hybrid 3+ days per week) My client is a Bay Area based Biotech that is developing cutting-edge treatments in cell therapy. Their pipeline consists of several programs, with a total of over 6 indications in the clinic. They are currently building out their Program Management team and are looking to bring on a cross-functional Associate Director Program Management that will report directly into the Director PM. Responsibilities: Provide cross-functional program management experience to pre-clinical, clinical, regulatory, CMC, etc. Develop and help execute timelines/roadmap for portfolio strategy The ideal candidate for this role will have: 4+ years of experience in cross-functional Program/Project/Portfolio Management Strong understanding of different regulatory bodies globally (FDA, EMA, APAC, etc.) Ability to successfully communicate with different department heads This company provides a competitive total rewards package: Annual bonus Equity Health, vision, dental insurance 401(k) match program Please apply now if you're interested!
US$140000 - US$185000 per year
San Francisco
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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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