Senior Director of Oncology Clinical Trial Operations

As a Senior Director of Oncology Clinical Trial Operations at Natera, you will lead and optimize our clinical trial operations in the oncology space, ensuring the successful execution of clinical studies from inception to completion. You'll collaborate with cross-functional teams to develop innovative strategies that align with our mission to improve patient outcomes through precision medicine.Your leadership will be pivotal in managing a team of dedicated professionals, fostering a culture of excellence and continuous improvement. The ideal candidate will possess a deep understanding of oncology clinical trials, regulatory requirements, and an ability to navigate complex project landscapes.

The Alliance for Clinical Trials in Oncology Foundation is dedicated to advancing cancer clinical research by expanding the capabilities of the Alliance for Clinical Trials in Oncology. Our mission is to address significant treatment challenges through large-scale clinical trials aimed at discovering innovative methods for the prevention, treatment, and cure of various cancers, including leukemia, lymphoma, and solid tumors such as breast, prostate, lung, and gastrointestinal cancers. We also strive to educate the medical community on effective cancer diagnosis, treatment, and prevention strategies.In 2014, we established the Alliance Foundation Trials, LLC (AFT), a wholly-owned subsidiary focused on conducting impactful cancer clinical research in collaboration with industry partners.We are currently seeking a Clinical Research Associate (CRA) to play a crucial role in the management and execution of clinical trial operations across AFT studies. The CRA will be responsible for site management and study start-up activities, including conducting feasibility assessments, supporting site selection, maintaining trial master files (eTMF), and overseeing clinical trial management systems (CTMS). The ideal candidate will work closely with CROs, vendors, and investigative sites to ensure compliance with ICH GCP guidelines and organizational standards throughout the study lifecycle. Join our team of dedicated professionals passionate about transforming cancer care.

Role overview The Senior Clinical Trials Scientist at CG Oncology, Inc. provides scientific leadership for Clinical Development and Operations. This remote position (United States) guides the scientific and strategic direction of global Phase II-III clinical trials. While this role does not include direct reports, it leads trial execution and serves as a key scientific resource for both internal teams and external partners. Success in this position relies on experience managing clinical programs in complex therapeutic areas, with a particular emphasis on oncology. The role involves shaping clinical strategy and upholding high standards in trial design, execution, data analysis, and reporting. Main responsibilities Lead the planning, design, and execution of complex Phase II-III clinical trials, ensuring compliance with regulatory, ethical, and scientific standards. Write and critically review study protocols, amendments, informed consent forms, clinical study reports (CSRs), and related clinical documentation.

Eikon Therapeutics is an innovative biopharmaceutical company that leverages cutting-edge technology at the intersection of chemistry, engineering, computation, and biology to develop groundbreaking treatments for severe diseases. Eikon's discovery platform is founded on remarkable innovations from its esteemed founders (Nobel Prize, 2014), leading to the development of advanced microscopes that provide real-time, molecular-resolution imaging of protein dynamics in living cells, thereby unlocking new classes of proteins as viable drug targets.Position OverviewWe are in search of a dynamic and experienced Clinical Trial Manager (CTM) to strengthen our oncology Clinical Operations team. This position necessitates an on-site commitment of at least three days a week at our offices in Millbrae, CA, or Jersey City, NJ, to facilitate effective global clinical trial management. The ideal candidate will excel in independent work, demonstrate strong leadership capabilities, and actively engage as a team member in a fast-paced environment. Your contribution will be critical in delivering high-quality clinical study management, ensuring adherence to regulatory standards, and aiding in the planning, execution, and successful completion of global clinical trials.Language ProficiencyThis role requires proficiency in Mandarin, Cantonese, Japanese, or Korean alongside strong English language skills (reading, writing, and speaking) to effectively interact with colleagues and stakeholders at all levels. About YouYou are a detail-oriented trial leader with global experience, known for your strong communication skills and collaborative nature. You are passionate about operational excellence and dedicated to enhancing patient care for serious illnesses.Your ResponsibilitiesLead the clinical trial management process from inception to completion while ensuring regulatory compliance.Collaborate with cross-functional teams to drive project milestones and timelines.Monitor and report on the progress of clinical trials, addressing any challenges and implementing effective solutions.

Join Eikon Therapeutics as a Clinical Trial Management Associate specializing in Oncology, where you will play a pivotal role in the management and execution of clinical trials across the EMEA and LATAM regions. This position is critical in ensuring that our clinical programs are conducted efficiently and in compliance with regulatory standards, ultimately contributing to the advancement of innovative treatments.

Join Natera, a pioneering genetics company dedicated to revolutionizing the field of oncology by improving clinical trial matching through innovative product management. As the Associate Director/Director of Product Management for Oncology Clinical Trial Matching, you will play a crucial role in shaping our product strategy and collaborating with cross-functional teams to enhance patient outcomes.

About Acadia Pharmaceuticals Acadia Pharmaceuticals is dedicated to transforming scientific breakthroughs into impactful innovations for communities affected by neurological and rare diseases globally. Our portfolio includes the first and only FDA-approved treatments for Parkinson’s disease psychosis and Rett syndrome. We are advancing a diverse pipeline of therapeutic solutions targeting Alzheimer’s disease psychosis and Lewy body dementia psychosis, alongside earlier-stage initiatives addressing additional patient needs. At Acadia, we strive to make a difference.Position Summary:The Director of Clinical Trial Materials (CTM) plays a critical role in supporting clinical development initiatives by assisting the Senior Director of CTM in both planning and operational execution for Phase I-IV studies and IIS trials. Responsibilities include defining both short and long-term objectives for the team, forecasting demand, managing budgets, establishing production timelines, reviewing protocols, ensuring compliance with labeling requirements, collaborating cross-functionally to meet regulatory standards, devising optimal packaging and distribution strategies, and monitoring drug supply levels while tracking product retest dates. This role requires effective interaction with internal departments, Contract Research Organizations (CROs), and Contract Manufacturing Organizations (CMOs) to coordinate the successful execution of clinical trial activities. Additionally, the Director will ensure adherence to global regulations and procedures related to the production and distribution of investigational products and mentor junior members of the CTM team as needed.Primary Responsibilities:Review and interpret clinical protocols or study overviews:Provide constructive feedback during the clinical protocol development process.Assess overall demand and translate this into a demand forecast.Collaborate with Project Managers to create clinical supply timelines, gather study overviews and drug requirements, and initiate procurement processes.Regularly review and update inventories and supply plans according to clinical forecasts, ensuring all supply-related information is accurate.

At Olema Oncology, we are committed to advancing innovative treatments for breast cancer and beyond. Our flagship program, palazestrant (OP-1250), represents a pioneering complete estrogen receptor antagonist (CERAN) currently under investigation for metastatic breast cancer, with significant potential both as a standalone therapy and in combination with existing treatments for ER+/HER2- metastatic breast cancer. Furthermore, our subsequent candidate, OP-3136, is a promising KAT6 inhibitor expected to set new standards in efficacy.We foster an environment of scientific excellence through unwavering support, motivation, and constructive challenges among our team members. At Olema, prioritizing our people ensures our work stands out in the industry. If you are prepared to embark on an exciting journey with us and make a meaningful difference for our patients, your career, and the future of medicine, we want to hear from you.Explore our latest corporate presentations here.About the Position: Senior Clinical Trial AssociateAs a Senior Clinical Trial Associate, you will report directly to the Senior Manager, Clinical Trial Leader, and provide essential administrative and operational support to our clinical teams throughout all phases of the study lifecycle, including both in-house and outsourced trials. Your role will facilitate seamless study execution through collaboration with internal teams, external vendors, and site personnel. This includes contributing to essential study documentation such as informed consent forms (ICFs) and central IRB submissions, managing site payments, and overseeing various operational tasks related to the study. You will also serve as a liaison to investigator sites, ensuring effective communication and follow-up.Your responsibilities will encompass assisting with study initiation, maintenance, and closure activities; managing study documentation and materials; supporting vendor management; and maintaining accurate study trackers and financial records. This role adheres strictly to Clinical Standard Operating Procedures and Good Clinical Practice (ICH) guidelines.This position is available in either our San Francisco or Cambridge office and will require approximately 10% travel.Your core responsibilities include:Supporting the Clinical Trial Lead (CTL) and Study Execution Team (SET) by ensuring accurate and comprehensive documentation of study conduct.Managing study-related vendors and acting as the primary contact for contracted CROs, study personnel, contract laboratories, and other relevant vendors.Being a key point of contact for investigator sites...

About Foresight Diagnostics Foresight Diagnostics specializes in non-invasive cancer detection using advanced, cell-free DNA-based liquid biopsy technologies. The company’s proprietary methods, developed at Stanford University, focus on identifying smaller tumors earlier and supporting personalized cancer treatment strategies. Now part of Natera, Foresight combines the energy of a mission-driven startup with the resources of a global leader in cell-free DNA testing. Headquartered in Boulder, Colorado, the team values collaboration, accountability, quality, and ongoing improvement in daily work. Role Overview: Clinical Trial Manager (Remote) The Clinical Trial Manager will guide clinical studies for Foresight’s MRD detection technology, helping move new diagnostics from research to patient care. This position manages the full study lifecycle, from start-up through reporting, and maintains quality and compliance standards throughout. The Clinical Trial Manager acts as the main point of contact between Foresight and its partners in biopharma and research institutions. This role reports to the Director of Clinical Operations and works closely with colleagues across clinical laboratory, bioinformatics, regulatory affairs, medical affairs, and operations teams. Key Responsibilities Oversee the planning, execution, and close-out of clinical studies, including companion diagnostic, investigator-initiated, and internally sponsored trials Maintain study timelines, budgets, and deliverables Serve as the primary liaison with external partners and internal cross-functional teams Ensure all clinical activities meet regulatory, ethical, and company standards Support continuous improvement and quality initiatives in clinical operations What Foresight Looks For Operational expertise in managing complex clinical studies Strong attention to detail and proactive problem-solving skills Effective communication and relationship management abilities Interest in precision oncology and advancing cancer diagnostics Location and Work Arrangement This is a full-time, remote position. Foresight Diagnostics is based in Boulder, CO, but welcomes candidates from other locations.

Position Overview:Celcuity is on the lookout for an experienced Senior Medical Director to join our dynamic medical team. Reporting directly to the Vice President of Clinical Development, you will play a pivotal role in overseeing clinical studies and ensuring the successful execution of our Phase I-III Oncology clinical trials. Your expertise will be essential in shaping study designs, protocols, and maintaining the highest standards of regulatory compliance.Key Responsibilities:Design, author, and review clinical study synopses, protocols, amendments, and related documents.Act as a medical monitor for assigned studies, providing guidance and support.Engage in discussions regarding study designs with investigators and leading experts.Contribute clinical insights for protocol monitoring and data analysis plans.Oversee clinical database design and ensure the integrity of data collection and cleaning processes.Monitor emerging efficacy and safety profiles of drugs in trials and communicate significant changes to the Clinical Development team.Prepare and review clinical sections of regulatory documents including INDs, Investigator’s Brochures, and consent forms.Lead or assist in the preparation of scientific publications such as abstracts and manuscripts.Collaborate with Clinical Operations and Data Management teams to evaluate and monitor vendors and trial conduct.Support the finalization of databases, review study results, and assist in writing clinical study reports.Assist in planning and conducting investigator meetings and advisory boards.Manage vendor activities and deliverables as necessary.Present study findings to the medical community at conferences and through publications.

Join Natera as a Clinical Director of Oncology Clinical Development, where you will lead innovative clinical trials and therapies aimed at transforming cancer care. In this pivotal role, you will collaborate with cross-functional teams to design, implement, and manage clinical development strategies that support the advancement of our oncology pipeline.

About the RoleThe Clinical Trial Systems and Process Manager plays a critical role in overseeing the strategic management, enhancement, and governance of clinical trial systems and operational processes. This position is dedicated to ensuring the execution of clinical development programs is of the highest quality, compliant, and ready for inspections. The incumbent will align systems to CG Oncology’s late-stage development, BLA timelines, and future commercialization goals. Proficiency in managing CTMS and eTMF platforms is essential, with a strong preference for candidates experienced with Veeva Vault.Essential FunctionsOversee and manage clinical trial systems, including CTMS, eTMF, and relevant platforms, with a strong preference for Veeva Vault.Define and maintain a roadmap for clinical systems aligned with Phase 3 programs and ongoing BLA milestones.Lead system implementations, configurations, validations, upgrades, and lifecycle governance.Design and standardize comprehensive operational workflows for clinical trials.

Position Overview: We are seeking a dedicated Clinical Trial Manager or Senior Clinical Trial Manager to take the lead in planning, conducting, and overseeing the operational aspects of clinical studies. You will ensure that all clinical trials are executed according to the established protocols, standard operating procedures (SOPs), ICH-GCP guidelines, and applicable regulatory requirements. Key Responsibilities: Act as the primary clinical contact for clients. Work collaboratively with project managers on monthly invoicing and clinical budget variance management. Create and maintain study-related clinical documents, including clinical plans, informed consent form templates, study-specific forms, manuals, CRF completion guidelines, study trackers, PSV/SIV slides, and other training materials. Identify and address training needs for Clinical Research Associates (CRAs) and third-party vendors, including presentations at investigator meetings and study kick-off sessions. Generate a list of potential sites from key stakeholders and lead the site feasibility process. Assess risks to enrollment targets based on feasibility analysis and site commitments. Devise and finalize recruitment and retention strategies for each country involved in the study. Establish effective communication and relationships with investigators and the study team to facilitate feasibility, site start-up, enrollment, maintenance, and close-out procedures. Lead internal clinical team meetings, setting clear expectations for CRAs and Clinical Trial Assistants (CTAs). Respond to all CRA and site inquiries while maintaining a Frequently Asked Questions (FAQ) log as necessary. Assist in planning and conducting investigator meetings. Review and approve investigational product release packages. Oversee and track all submissions and approvals to Competent Authorities and IRB/Ethics Committees in collaboration with regulatory departments as required. Develop clinical monitoring strategies to ensure study timelines and quality deliverables are met. Utilize metric reporting tools (e.g., CTMS, DM Query Trends, Outstanding Monitoring Reports) to confirm compliance with study plans and communicate issues to project managers and CRAs as needed. Manage the implementation and oversight of the electronic Trial Master File (eTMF).

The Alliance for Clinical Trials in Oncology Foundation is a dedicated non-profit organization aimed at bolstering the capacity of the Alliance for Clinical Trials in Oncology to advance cancer clinical research and tackle significant treatment inquiries via expansive clinical trials. Through the Foundation's support of the Alliance, groundbreaking clinical trials and laboratory research are conducted, paving the way for novel or enhanced strategies to prevent, treat, and ultimately cure various cancer types, including leukemia, lymphoma, breast, prostate, lung, and gastrointestinal cancers. The Foundation also plays a crucial role in educating the medical community on cancer diagnosis, treatment, and prevention methods.The Alliance for Clinical Trials in Oncology is a prominent clinical trials network sponsored by the National Cancer Institute, comprising approximately 10,000 cancer specialists across over 1,000 member hospitals, medical centers, and community sites throughout the United States and Canada. The Alliance is at the forefront of developing and executing clinical trials for promising new cancer therapies, leveraging cutting-edge science to create optimal treatment and prevention strategies for cancer, alongside innovative approaches to mitigate the side effects of cancer and its treatments.The Alliance encompasses both the Alliance for Clinical Trials in Oncology and the Alliance for Clinical Trials in Oncology Foundation, along with its entities such as the Alliance NCTN Foundation (ANF), Alliance Foundation Trials, LLC (AFT), and Alliance Data Innovation Lab, LLC (Data Lab).Benefits of joining the Alliance for Clinical Trials in Oncology Foundation:8 weeks of paid time off (including PTO, sick leave, and holidays) during the first yearComprehensive Medical, Dental & Vision plans with a fully employer-paid option for employeesTuition reimbursement programsContinuing Education opportunities3% employer match on retirement contributionsAnnual Employee Performance BonusAnnual Cost of Living Adjustments50% reimbursement for commuting expensesSupport for a healthy work/life balance with flexible options

Join our dynamic team as a Clinical Trial Leader, where you will be at the forefront of innovative clinical research. You will be responsible for overseeing the planning, execution, and management of clinical trials, ensuring compliance with all regulatory requirements and organizational standards. Your leadership will guide cross-functional teams to deliver high-quality results, contributing to the advancement of healthcare solutions.

Join Equus as an Operations and Clinical Trials Project Director, where you will lead and manage pivotal clinical projects, ensuring that all operations run smoothly and efficiently. You will be responsible for the overall planning, execution, and success of clinical trials, collaborating with multidisciplinary teams to achieve outstanding results.

Headlands Research is seeking a Clinical Trials Site Director to manage clinical trial sites throughout the United States. This is a remote position with responsibility for guiding teams and ensuring that clinical studies are conducted efficiently and in line with established protocols. Role overview The Clinical Trials Site Director will provide leadership for site operations, working with staff across several locations. Key priorities include supporting the execution of clinical trials and maintaining compliance with regulatory requirements and quality standards. What you will do Oversee day-to-day activities at multiple clinical trial sites Lead and support site teams to achieve study objectives Ensure adherence to regulatory guidelines and quality protocols Requirements Experience managing clinical trial sites or teams Strong understanding of regulatory compliance in clinical research Ability to work remotely and coordinate across multiple locations

Join Iambic Therapeutics as a Senior Clinical Trial Manager in Clinical Operations, where you will take the lead on early-phase oncology studies, overseeing the entire trial process from initiation to completion. You will collaborate closely with teams in Clinical Development, Regulatory Affairs, Biometrics, and external CROs to ensure that trials are executed with the highest quality standards and are ready for inspections in a dynamic biotech environment.In this role, you will be responsible for vendor management, risk assessment, adherence to timelines and budgets, and fostering cross-functional collaboration to guarantee studies meet global regulatory requirements, ICH-GCP standards, and internal SOPs. Reporting directly to the Director of Clinical Operations, this position is based in San Diego, CA.

As a Clinical Program Manager specializing in Oncology at Eikon Therapeutics, you will play a pivotal role in coordinating and overseeing clinical programs that are crucial to advancing our innovative therapies. Your expertise will help align cross-functional teams, ensuring the successful execution of clinical trials and adherence to regulatory requirements.

Join our dynamic team as a Clinical Trial Assistant where you will play a pivotal role in supporting clinical research projects. As a key member of our team, you will assist in the management and coordination of clinical trials, ensuring compliance with regulatory standards and facilitating communication among stakeholders.