Sr. CTM
Sr. Clinical Trial Manager San Diego, California (Hybrid) Compensation: $160,000-180,000 + Bonus + Equity Company Summary: We are partnered with an Cell Therapy focused company looking to revolutionize the way we approach cell therapy within Oncology & Autoimmune diseases. Their proprietary approach will dramatically cut time and cost associated with other cell therapy treatments like CAR-T. Their leadership team is equally exciting as their science with their CEO and CMO successfully raising hundreds of millions in funding at other organizations while gaining successful approvals. Their strong leadership has also led to a successful IPO for this organization earlier this year. If interested in learning more don't hesitate to apply. Primary Responsibilities: Support the Clinical Operations team in executing clinical trials, from protocol development through to the final study report. Prepare and manage study-related documentation. Organize and facilitate study and departmental meetings, document meeting minutes, and ensure proper archiving of study files. Oversee the coordination of clinical trial equipment and supplies. Manage cross-functional project activities, such as Clinical Data Review Meetings. Ensure team adherence to required study-specific training. Conduct Trial Master File (TMF) reviews to ensure completeness. Maintain inspection readiness and assist sites in preparing for clinical audits or inspections. Assist with managing budgets. Support daily clinical trial operations, ensuring adherence to SOPs, ICH/GCP guidelines, and other regulatory standards. Tasks may include tracking subject and site activity/metrics and performing quality checks on various aspects of the clinical study. Proactively identify and address issues related to functional deliverables. Assist with study setup, including protocol/synopsis development, informed consent form review, and regulatory submissions, as well as preparing operational and training manuals, study plans (visit logs, drug inventory, monitoring plans), and other related documents. Collaborate with CROs to ensure timely collection and archiving of TMF documents for assigned studies or programs. Coordinate with regulatory affairs to submit essential documents to authorities. Support study completion activities with CROs and sites, including TMF and drug reconciliation, and ensure all documents are ready for the Clinical Study Report (CSR). Communicate effectively with study teams and work closely with Clinical Trial Managers and Asset Leads. Contribute to process improvement and quality initiatives related to study execution and deliverables. Ensure study timelines are met, including first patient in (FPI), enrollment targets, site activation, and data cleaning goals. Qualifications: 5+ years clinical operations experience. Experience in Autoimmune, or another complex therapeutic area
US$160000 - US$180000 per year + + Bonus + Equity
San Diego
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Associate Consultant/Submission Lead
Remote working opportunity! My client is a global consulting company that provides different solutions for companies in the life science industry They are currently looking for an Associate Consultant to join their team. Responsibilities: Manage and coordinate global submission documentation across new and existing accounts, ensuring all deliverables meet customer expectations. Lead or participate in Regulatory Information Management or Systems projects related to global submission documentation. Collaborate with partners, subject matter experts, and industry specialists to address customer business requirements and needs. Provide global expertise on electronic document management, submission planning, report publishing, and eCTD compilation, including translation of submission requirements between Japanese and English. Oversee project management and quality control for regional Japan eCTD submissions and support global eCTD submissions, ensuring compliance with submission-ready standards and regulatory requirements. Requirements: Bachelor's degree Over 5 years in the pharmaceutical industry, focusing on regulatory operations like eCTD publishing and submission management. Experience in managing major submissions and assisting with project management. Fluent in Japanese and English. Proficient in Microsoft Suite, Adobe Acrobat, Evermap or ISIToolbox, and eCTD publishing tools; experience with regulatory systems like Documentum, Veeva Vault, and docuBridge. If you are interested, please apply with your CV attached.
Negotiable
Japan
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Director of Clinical Operations
Title: Director of Clinical Operations, Greater Boston Area, Hybrid Salary: $220,000-$250,000 Company Summary: We're partnering with a biotechnology firm focused on developing innovative therapeutics to address metabolic disorders, particularly type 2 diabetes and obesity. At the forefront of their research is a novel GLP-1 receptor agonist aimed at enhancing glycemic control and promoting weight loss in patients. This company has raised over half a billion dollars in funding that gives them plenty of cash runway for their trials to succeed. They are looking for a new director of clinical operations in their Boston office to pioneer them to market. The director of clinical operations will be responsible for: Establish and continuously update global study timelines and budgets, ensuring all internal functions, vendors, and CROs are aligned. Lead the selection and management of CROs, consultants, and vendors, including developing proposals and overseeing their activities. Develop and enforce study-specific operational plans and processes, in collaboration with vendors, ensuring adherence to protocols, GCP/ICH guidelines, and regulations. Oversee the creation of study budgets, collaborating with cross-functional leads, and act as the main liaison with finance and leadership throughout the study. Responsible for hiring, firing, and team growth. The director of clinical operations should have the following qualifications: 6 years of clinical trial experience, 5 years of management experience. Experience building and leading teams, overseeing big picture. Sponsor side and small biotech experience. Benefits 401k with company matching. Health insurance with excellent family plan. Competitive stock options for employees. Pre-IPO with equity offerings.
US$220000 - US$250000 per year
Boston
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Director of Clinical Operations
Title: Director of Clinical Operations, Greater Boston Area, Hybrid Salary: $220,000-$250,000 Company Summary: We're partnering with a biotechnology firm focused on developing innovative therapeutics to address metabolic disorders, particularly type 2 diabetes and obesity. At the forefront of their research is a novel GLP-1 receptor agonist aimed at enhancing glycemic control and promoting weight loss in patients. This company has raised over half a billion dollars in funding that gives them plenty of cash runway for their trials to succeed. They are looking for a new director of clinical operations in their Boston office to pioneer them to market. The director of clinical operations will be responsible for: Establish and continuously update global study timelines and budgets, ensuring all internal functions, vendors, and CROs are aligned. Lead the selection and management of CROs, consultants, and vendors, including developing proposals and overseeing their activities. Develop and enforce study-specific operational plans and processes, in collaboration with vendors, ensuring adherence to protocols, GCP/ICH guidelines, and regulations. Oversee the creation of study budgets, collaborating with cross-functional leads, and act as the main liaison with finance and leadership throughout the study. Responsible for hiring, firing, and team growth. The director of clinical operations should have the following qualifications: 6 years of clinical trial experience, 5 years of management experience. Experience building and leading teams, overseeing big picture. Sponsor side and small biotech experience. Benefits 401k with company matching. Health insurance with excellent family plan. Competitive stock options for employees. Pre-IPO with equity offerings.
US$220000 - US$250000 per year
Boston
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Clinical Research Assistant
Clinical Research Associate San Francisco Bay Area Salary: $90,000-$110,000 A global specialty biopharma company is looking for new members to join their clinical team on a full time basis as they ramp up a large global Ph. 3 study. They currently have 8 indications across 2 programs ranging from preclinical to Ph. 3. They've also had 3 approvals in various global markets for their lead asset. This company has had year over year revenue growth for the past three years. This role is remote with plans to transition to hybrid with a 2-3 day in office requirement, and their entire US team is located in the SF Bay Area. The Clinical Trial Specialist will be responsible for: Oversee site management, including the supply of materials, payment processes, and related activities. Manage site setup, initiation, monitoring, close-out, and overall management of clinical and post-authorization study sites on an as-needed basis. Collaborate with the Clinical Project Manager or designee for site evaluation and setup related to commercial distribution, including dosing training. Track and report on the status of clinical trials and studies, providing regular progress updates to the team. Oversee data collection and pharmacovigilance/safety reporting at post-authorization study sites. Ensure the collection of essential documents in compliance with ICH-GCP E6 (R2) and applicable regulations. Prepare and submit regulatory documents to EC/IRB and other relevant bodies. Maintain relationships with commercial distribution sites and those involved in clinical trials. Participate in investigator meetings The Clinical Trial Specialist should have the following qualifications: Graduate qualifications in Biological Sciences, Nursing, Pharmacy or related discipline At least 2 years proven experience as a CRA Working knowledge of ICH GCP guidelines Proven experience in managing clinical trials/project Benefits: A competitive salary with benefits. A real hands-on opportunity to gain a high degree of commercial exposure. Working with highly-talented and dedicated colleagues in a fast-growing company that combines a focus on cutting-edge science with commercial delivery If you are interested in the Clinical Trial Specialist role, then please don't wait to apply.
US$90000 - US$110000 per year
San Francisco
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Clinical Trial Manager
Title: Clinical Trial Manager Salary: $130,000-$142,000 We just partnered with one of the hottest biotech's around at the moment that is growing its Clin Ops team ahead of a large phase 3 Oncology trial. This company is founded and led by some of the industries brightest with their C suite coming from well-established big pharma. This company is one that has potential well beyond just one blockbuster drug due to their proprietary drug discovery platform. This exciting company has applications in oncology, neurology and immunology. The Clinical Trial Manager will be responsible for: Handle all trial start-up activities, partnering with Clinical Operations functions (such as Site Engagement & Monitoring Excellence, and Supplier Relationship Management & Performance) to ensure efficient site selection, feasibility assessments, and preparation of study documentation. Oversee and guide the comprehensive in-house management of international clinical trials, ensuring the delivery of high-quality study data within the established timelines and budget. Collaborate with external vendors, including CROs, central laboratories, and imaging providers, as needed, to ensure their efficient and effective contribution to the trial. Lead the creation and maintenance of all study files, including the study master file, and oversee site files and conduct periodic reviews of the Sponsor Trial Master File. The Clinical Trial Manager should have the following qualifications: Four years experience in clinical trial managemenet. Five years expereince in oncology, neurology, and immunology. Eight years experience in clinical trials. Benefits: 401k plan with company matching. Generour PTO, holidays, and parental leave. Medial (premiums 95% covered) , dental, and vision (premiums 100% covered) If you are interested in this Clinical Trial Manager role, please do not wait to apply.
US$130000 - US$142000 per year
Jersey City
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Clinical Trial Manager
Title: Clinical Trial Manager Salary: $130,000-$142,000 We just partnered with one of the hottest biotech's around at the moment that is growing its Clin Ops team ahead of a large phase 3 Oncology trial. This company is founded and led by some of the industries brightest with their C suite coming from well-established big pharma. This company is one that has potential well beyond just one blockbuster drug due to their proprietary drug discovery platform. This exciting company has applications in oncology, neurology and immunology. The Clinical Trial Manager will be responsible for: Handle all trial start-up activities, partnering with Clinical Operations functions (such as Site Engagement & Monitoring Excellence, and Supplier Relationship Management & Performance) to ensure efficient site selection, feasibility assessments, and preparation of study documentation. Oversee and guide the comprehensive in-house management of international clinical trials, ensuring the delivery of high-quality study data within the established timelines and budget. Collaborate with external vendors, including CROs, central laboratories, and imaging providers, as needed, to ensure their efficient and effective contribution to the trial. Lead the creation and maintenance of all study files, including the study master file, and oversee site files and conduct periodic reviews of the Sponsor Trial Master File. The Clinical Trial Manager should have the following qualifications: Four years experience in clinical trial managemenet. Five years expereince in oncology, neurology, and immunology. Eight years experience in clinical trials. Benefits: 401k plan with company matching. Generour PTO, holidays, and parental leave. Medial (premiums 95% covered) , dental, and vision (premiums 100% covered) If you are interested in this Clinical Trial Manager role, please do not wait to apply.
US$130000 - US$142000 per year
Jersey City
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Director of Clinical Operations
Title: Director of Clinical Operations Salary: $220,000-$2350,000 Company Summary: This hot biotech has raised $1 billion dollars in funding since being founded in 2016. They are the first targeted protein degradation (TPD) biotech of its kind. Their goal is to reinvent the treatment of diseases, hoping to reach the patients that have not been reached before. This company is nearing phase three and looking to expand their clinical operations team. This will give you the opportunity to join right before explosive growth. The Director of Clinical Operations will be responsible for: Direct and manage the strategic planning, implementation, and execution of clinical trials for a key immunology program, ensuring compliance with project timelines, budgets, and quality standards. Collaborate with various internal teams, such as Clinical Development, Regulatory Affairs, Biostatistics, Translational Medicine, and Program Leadership, to align on clinical trial objectives and milestones. Serve as the primary contact for CROs and vendors, managing their performance to ensure they meet contractual obligations, timelines, and quality benchmarks. Prepare and review clinical study documents, such as the Investigator Brochure, Investigational New Drug Applications (IND), study protocols, clinical study reports, and relevant sections of New Drug Applications (NDA) and Marketing Authorization Applications (MAA), including updates and safety reports. The Director of Clinical Operations should have the following qualifications: 10-12 years of clinical trial experience, with 5-7 years leading global trials Oncology, immunology, and inflamatory disease experience Building and leading clinical operations teams Benefits Wide range of benefits covered by company (health, dental, HSA, vision, life, mental health, disability) Hybrid work schedule with three days in office, two days remote Culture of constant improvmenet and commitment to meet employee's needs If you are interested in the role Director of Clinical Operations role, please don't hesistate to apply.
US$220000 - US$230000 per year
Cambridge
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Associate Director of Clinical Operations
Title: Associate Director of Clinical Operations Salary: $175,000-$190,000 Company Summary: We're partnering with a rapidly expanding radiopharmaceutical company that has three products approved on the on the market. This company has had year over year revenue growth the past three years, and in the last year generated over $1 billion showing a 38% growth. They are looking to grow their clinical operations team at their Massachusetts location. The associate director of clinical operations will be responsible for: Establish and continuously update global study timelines and budgets, ensuring all internal functions, vendors, and CROs are aligned. Lead the selection and management of CROs, consultants, and vendors, including developing proposals and overseeing their activities. Develop and enforce study-specific operational plans and processes, in collaboration with vendors, ensuring adherence to protocols, GCP/ICH guidelines, and regulations. Oversee the creation of study budgets, collaborating with cross-functional leads, and act as the main liaison with finance and leadership throughout the study. The associate director of clinical operations should have the following qualifications: 10 years of clinical trial experience, with 5 years of trial management experience. Oncology, neurology, and radiopharmaceuticals experience. Sponsor side and small biotech experience. Monitoring Benefits: (think of the sizzle points) 401k with company matching. Health insurance with excellent family plan. Competitive stock options for employees. If you are interested in the associate director role, then please don't wait to apply.
US$175000 - US$190000 per year
Bedford
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Senior Director, R&D Finance
Senior Director, R&D Finance West Chester, PA or Parsippany, NJ (2-days onsite) Job Responsibilities: Lead financial planning, reporting, and KPI development for Innovative Medicine programs and segments. Act as a financial advisor for R&D projects and pipeline teams, improving forecast accuracy and business performance. Provide strategic finance insights in leadership meetings and internal governance forums. Support business development and ensure financial alignment as the R&D finance expert. Coordinate with external partners on financial projections and commitments, and handle additional ad hoc tasks. Requirements: Bachelor's in Economics/Accounting and MBA. 15+ years in senior finance roles within the global pharmaceutical sector. Global Clinical Operations experience required Expertise in R&D pharmaceuticals, budgeting, forecasting, and expense management. Strong strategic, analytical, and problem-solving abilities. Proficient in managing complex processes, with experience in business development and tools like Excel, PowerPoint, and SAP.
Negotiable
West Chester
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Clinical Trial Manager
Title: Clinical Trial Manager Salary: $130,000-$142,000 We just partnered with one of the hottest biotech's around at the moment that is growing its Clin Ops team ahead of a large phase 3 Oncology trial. This company is founded and led by some of the industries brightest with their C suite coming from well-established big pharma. This company is one that has potential well beyond just one blockbuster drug due to their proprietary drug discovery platform. This exciting company has applications in oncology, neurology and immunology. The Clinical Trial Manager will be responsible for: Handle all trial start-up activities, partnering with Clinical Operations functions (such as Site Engagement & Monitoring Excellence, and Supplier Relationship Management & Performance) to ensure efficient site selection, feasibility assessments, and preparation of study documentation. Oversee and guide the comprehensive in-house management of international clinical trials, ensuring the delivery of high-quality study data within the established timelines and budget. Collaborate with external vendors, including CROs, central laboratories, and imaging providers, as needed, to ensure their efficient and effective contribution to the trial. Lead the creation and maintenance of all study files, including the study master file, and oversee site files and conduct periodic reviews of the Sponsor Trial Master File. The Clinical Trial Manager should have the following qualifications: Four years experience in clinical trial managemenet. Five years expereince in oncology, neurology, and immunology. Eight years experience in clinical trials. Benefits: 401k plan with company matching. Generour PTO, holidays, and parental leave. Medial (premiums 95% covered) , dental, and vision (premiums 100% covered) If you are interested in this Clinical Trial Manager role, please do not wait to apply.
US$130000 - US$142000 per year
Jersey City
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