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Ad/d Clinical Operations
1 week ago
VistaGen Therapeutics South San Francisco, United StatesPosition Overview: · Reporting to the Sr. Director, Clinical Operations, this individual will function as a cross-functional study team lead for the clinical trial program, responsible for delivery of all clinical trial operational activities, potentially across multiple studies. ...
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Clinic Operations Manager
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Health Right 360 San Francisco, United StatesHealthRIGHT 360 gives hope, builds health, and changes lives for people in need by providing comprehensive, integrated, compassionate care that includes primary medical care, mental health services, and substance use disorder treatment. · The Integrated Care Center Clinic is a fe ...
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Clinical Operations Manager
2 weeks ago
Mochi Health San Francisco, United StatesIn a world where healthcare can feel like a maze of bureaucracy and frustration, Mochi Health offers a refreshing oasis. We're not just another telehealth clinic - we're on a mission to rewrite the script on healthcare, starting with the most overlooked areas of medicine. With a ...
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Clinical Operations Director
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Stirling Q&R Ltd San Jose, United States**Clinical Operations Director** · Our client is a leading provider of expanded access clinical trials. This company is seeking an experienced Clinical Operations Director to join their growing team. In this pivotal role, you will oversee the end-to-end operational execution of i ...
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Associate Director, Clinical Business Operations
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Arsenal Biosciences South San Francisco, United StatesArsenalBio, a privately held programmable cell therapy company engineering advanced CAR T therapies for solid tumors, is seeking a talented Associate Director, Clinical Business Operations to work hybrid or remotely.ArsenalBio's mission is to develop efficacious and safe cellular ...
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Clinical Operations Manager
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Integrated Resources, Inc ( IRI ) San Mateo, United StatesJob Description: · Function: Clinical Operations – Biomarker and Bioanalytical Operations · Position overview: · Clinical Operations is responsible for the worldwide execution of all Phase I - IV clinical trials across all Client therapeutic areas. Clinical Operations plays a key ...
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Supervisor Clinical Operations
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Upward Health San Mateo, United StatesJob Description · Job DescriptionSupervisor, Clinical Operations · Upward Health is a home-based medical group specializing in primary medical and behavioral care for individuals with complex needs. We serve patients throughout their communities, and we diagnose, treat, and presc ...
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Clinical Operations Manager
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ACL Digital San Mateo, United StatesFUNCTION: Clinical Operations – Biomarker and Bioanalytical Operations · 6months contract · POSITION OVERVIEW: · Onsite In Foster City- Hybrid · Clinical Operations is responsible for the worldwide execution of all Phase I - IV clinical trials across all Gilead therapeutic areas ...
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Clinical Operations Coordinator
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Joyous San Mateo, United StatesJob Description · Job Description · Join Joyous in our mission to revolutionize mental health care. As pioneers, we leverage very low dose (VLD) ketamine, AI-powered treatments, and advanced technologies to make mental health care effective, accessible, and affordable. With a t ...
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Supervisor Clinical Operations
2 weeks ago
Upward Health San Mateo, United StatesSupervisor, Clinical Operations · Upward Health is a home-based medical group specializing in primary medical and behavioral care for individuals with complex needs. We serve patients throughout their communities, and we diagnose, treat, and prescribe anywhere our patients call h ...
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Supervisor Clinical Operations
2 weeks ago
Upward Health San Mateo, United StatesSupervisor, Clinical Operations · Upward Health is a home-based medical group specializing in primary medical and behavioral care for individuals with complex needs. We serve patients throughout their communities, and we diagnose, treat, and prescribe anywhere our patients call h ...
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Clinical Operations Coordinator
1 week ago
Joyous San Mateo, United StatesJob Description · Job DescriptionJoin Joyous in our mission to revolutionize mental health care. As pioneers, we leverage very low dose (VLD) ketamine, AI-powered treatments, and advanced technologies to make mental health care effective, accessible, and affordable. With a team o ...
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Varite San Mateo, United StatesFUNCTION: Clinical Operations – Biomarker and Bioanalytical Operations · Pay Range: $ $80.00/hr on W2 (Competitive Bid) · POSITION OVERVIEW: · Onsite In Foster City- HybridClinical Operations is responsible for the worldwide execution of all Phase I - IV clinical trials across al ...
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Gilead Sciences San Mateo, United StatesCLINICAL OPERATIONS: Clinical Operations is responsible for the execution of all Phase 1-4 clinical trials, across all therapeutic areas, around the world. In partnership with Clinical Research, Medical Affairs and Development functions, ensures that Clinical, Operations, Manager ...
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Clinical Operations Manager
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Infotree Global Solutions Foster City, United StatesJob Title: Clinical Operations Manager (Biomarker and Bioanalytical) · W2 Contract & Hybrid role · Work Location: Foster City, CA · One of our leading Pharmaceutical client is looking for a Clinical Operations Manager (Biomarker and Bioanalytical), who will serves as the key biom ...
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Sr Director, Clinical Operations
3 weeks ago
Kronos Bio, Inc. San Mateo, United StatesAbout Kronos Bio · Kronos Bio, Inc. is dedicated to the discovery and development of first-in-class therapies that modulate historically undruggable targets. We leverage deep capabilities in high-throughput small molecule microarrays (SMM), targeted protein degradation, and cance ...
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Clinical Trial Operations Manager
3 days ago
ACL Digital San Mateo, United StatesJob Title: Clinical Trial Manager · Location: Foster City, CA · Duration: 06 Months · Description: · FUNCTION: Clinical Operations – Biomarker and Bioanalytical Operations · POSITION OVERVIEW: · Onsite In Foster City- Hybrid · Clinical Operations is responsible for the worldwid ...
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Clinical Trial Operations Manager
1 week ago
ACL Digital San Mateo, United StatesJob Title: Clinical Trial Manager · Location: Foster City, CA · Duration: 06 Months · Description: · FUNCTION: Clinical Operations – Biomarker and Bioanalytical Operations · POSITION OVERVIEW: · Onsite In Foster City- Hybrid · Clinical Operations is responsible for the worldwide ...
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Sr Director, Clinical Operations
4 weeks ago
Kronos Bio San Mateo, CA, United StatesAbout Kronos Bio Kronos Bio, Inc. is dedicated to the discovery and development of first-in-class therapies that modulate historically undruggable targets. We leverage deep capabilities in high-throughput small molecule microarrays (SMM), targeted protein degradation, and cancer ...
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Director, Clinical Laboratory Operations
4 weeks ago
Illumina, Inc. San Mateo, CA, United StatesWhat if the work you did every day could impact the lives of people you know? Or all of humanity? At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are tra ...
Sr Director, Clinical Operations - San Mateo, United States - Kronos Bio
Description
Kronos Bio, Inc. is dedicated to the discovery and development of first-in-class therapies that modulate historically undruggable targets.We leverage deep capabilities in high-throughput small molecule microarrays (SMM), targeted protein degradation, and cancer biology in order to identify potent and selective compounds against transcription factors and other central drivers of oncogenic signaling.
Summary of Position:
We are seeking an experienced and dynamic individual to join our team as Senior Director of Clinical Operations.
The successful candidate will provide leadership to assigned clinical program (s) and for ensuring studies (IND through late stage) are being managed in accordance with the company's overall program goals, timelines, budget and quality expectations.
Reporting to Vice President of Clinical Development Operations, this role requires strong leadership skills, strategic thinking and an individual who thrives in fast paced biotech environment and is willing to wear multiple hats to drive success.
Essential Duties and Responsibilities:
Lead and oversee all aspects of assigned clinical program (s) from Investigational New Drug (IND) through late-stage phases of the clinical program.
Develop and implement comprehensive clinical operations plans for assigned clinical programs in collaboration with the cross-functional teams, considering global regulatory requirements.
Collaborate with the VP of Development Operations, to ensure prioritization and alignment of resources and budgets across assigned clinical programs.
Provide leadership to clinical studies to ensure study teams are managed in alignment with clinical program and company goals.Give regular clinical program updates, including trial status, metrics, budget, accomplishments and risks to relevant stakeholders and Senior Management.
Provides operational and strategic input and/or approves clinical study documents, such as project timelines, protocols, investigator brochures, pharmacy manuals, laboratory manuals, informed consent, study start-up plans, monitoring plans, CRF Completion Guidelines and CSR.
Responsible for and participates in clinical service provider (vendor) selection process as a part of outsourcing activities.Oversees/responsible for the TMF set-up, ongoing quality review and final reconciliation of study documents including review of site regulatory documents/packages.
Identify, manage, and maintain relations with clinical trial sites, including collaboration with PIs and patient recruitment strategies to deliver enrollment targets.
Perform or oversee co-monitoring visits to ensure monitoring is being conducted in alignment with ICH/GCP guidelines and study-specific monitoring plan.
Prepare teams for regulatory agency audits and address any audit observations appropriately in collaboration with Quality.Implement best practices and standards for clinical operations including development of internal standard operating procedures as needed.
Manage the performance and professional development of direct reports, emphasizing the importance of adaptability, execution of clinical studies by embracing changes, and through shifting strategic priorities.
Qualifications:Bachelors or Master's Degree in health related field is required.
Minimum of 12 years managing global Phase 1-IV clinical studies. On-site monitoring experience strongly preferred.
Minimum of 4-6 years of prior supervisory experience.
Expert knowledge of ICH/GCP guidelines, regulatory requirements, and industry best practices.
Hands-on experience in contract review and negotiation with CROs and vendors under the legal team's support.
Previous experience leading multiple trials; leading multidisciplinary trial teams in a complex matrix environment and proven ability working in a fast-paced environment.
Strong ability to prioritize tasks and keen attention to detail.Excellent writing, communication, and presentation skills.
Strong interpersonal skills with the ability to interact effectively with all levels of associates both within and outside the organization.
The expected annual salary range for this full-time position is $240,000 - $295,000, plus eligibility for bonus, benefits, and equity incentives.
Actual pay will be determined based on experience, qualifications, business needs, internal equity, and alignment with market data.The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification.
They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.
As set forth in Kronos Bio's Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.
If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.
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An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S.military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.
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As set forth in Kronos Bio's Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.
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a veteran of the U.S.
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An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S.military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.
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