267 Senior Director Clinical Affairs jobs in Santa Clara
Senior Director, Clinical Affairs
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At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.
We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential. At Johnson & Johnson, we all belong.
The Senior Director of Clinical Affairs will play a key leadership role as the company continues to transform the treatment of poorly served patient populations with paradigm changing technologies. The role will be responsible for a portfolio of complex clinical studies and requires a high level of autonomy and impact. This Senior Director of Clinical Affairs role will specifically be responsible for oversight of the clinical program for Shockwave's coronary sinus reducer. The candidate will work with physician advisors and other external stakeholders including regulatory bodies. The individual will be responsible for building and maintaining a high-functional clinical team and for the oversight of external research partners. Significant hands-on oversight of complex clinical studies and implementation work is required in this role.
The Senior Director of Clinical Affairs will come with a background in creating and executing clinical strategy and influencing internal stakeholders within the product development team to drive business results. The candidate should have experience with cardiovascular medical devices and cross-functional product development core teams including risk management and clinical strategy. This candidate is accountable for clinical study management activities, for providing work direction to in-house clinical staff, and for successful completion of clinical milestones in compliance with applicable regulatory and business standards. The candidate is responsible for coordination with cross-functional counterparts and contract research organizations (CROs) across global studies in conformance with applicable regulatory requirements to meet business objectives. The Senior Director of Clinical Affairs will establish processes and best practices, in addition to maximizing metrics and reporting on clinical activities. Significant interactions with physician investigators and study staff are required on the use of Shockwave Medical products during the clinical investigation to ensure the clinical data reported are complete, accurate and true.
This position requires critical thinking skills with respect to program strategy and clinical operations execution to evaluate the safety and effectiveness of new and existing products. This work is accomplished with minimal oversight, requires frequent contact with internal and external customers, and has significant impact to the business.
Essential Job Functions
• Design and execute global studies for regulatory submissions, reimbursement and product adoption, including clinical study documents (protocol, case report forms, etc.), study implementation and data management activities.
• Partner with cross-functional partners in product development to meet business objectives.
• Obtain in-depth knowledge of clinical issues that may impact clinical and business objectives.
• Develop and execute clinical strategies.
• Manage key study investigators; foster and maintain strong relationships through direct interactions with medical advisors and clinical leaders.
• Lead internal clinical research teams to ensure milestones are met. Coach and mentor the team to maximize performance.
• Oversee the performance of CROs and external research partners to ensure study integrity and business milestones are met.
• Oversee administrative activities associated with the clinical department including development and maintenance of clinical procedures, hiring and training of key personnel, and preparation and maintenance of objectives and budgets.
• Oversee study start-up including clinical contracts, CROs, data management activities and clinical study teams to meet business priorities.
• Oversee a team of field clinical engineers providing case support for clinical procedures.
• Manage study enrollment by ensuring appropriate enrollment strategies are in place to meet milestones.
• Ensure data integrity during conduct of study, oversee clinical data analysis, clinical study reports and participate in evidence dissemination.
• Other duties as assigned.• Minimum Bachelor's Degree in a scientific field of study.
• Minimum 15 years' experience directly supporting clinical research including 5 years of managerial experience.
• Working knowledge of Good Clinical Practice (GCP) and regulatory compliance guidelines for clinical trials.
• A history of effective collaboration with regulatory agencies through clinical studies and market releases.
• Strong knowledge of FDA and international regulations and guidelines including, but not limited to, clinical strategy, GCPs, SOPs, submissions, product launch, labeling, advertising and promotion, product vigilance and medical device reporting.
• Excellent prioritization and organizational skills.
• High attention to detail and accuracy.
• Finance and budgeting knowledge.
• Excellent critical thinking influencing and negotiation skills.
• Works effectively on cross-functional teams.
• Effective written, verbal and presentation skills with all levels of management and organizations.
• Operate both as a team and independently, with adaptability to changing requirements.
• Ability to work in a fast-paced environment, managing multiple priorities.
• Ability to travel 30-40% domestically and internationally as needed.
The anticipated base pay range for this position is 193000 to 333500. California Bay Area - The anticipated base pay range for this position is 238000 to 382950.
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Director of Clinical Operations
Posted today
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About Power
At Power, we believe every patient should have easy access to clinical trials as a care option. Our platform connects patients to research opportunities quickly, transparently, and compassionately helping sponsors and sites accelerate enrollment while improving diversity and retention.
Were growing fast and looking for a Director of Clinical Operations to lead the team that works directly with sponsors and sites to ensure recruitment success. This is a high-impact role where you'll be the bridge between our technology, our customers, and the patients we serve.
What Youll Do
- Lead and grow the Clinical Operations team responsible for executing patient recruitment programs for Phase 2/3 interventional studies across multiple therapeutic areas.
- Serve as the primary strategic partner to sponsors and sites, ensuring alignment on goals, timelines, and quality standards.
- Oversee the design, launch, and optimization of recruitment campaigns, ensuring targets for enrollment, diversity, and site engagement are met or exceeded.
- Develop operational playbooks and processes to scale quality, compliance, and security without sacrificing patient experience.
- Partner cross-functionally with Product, Data, and Marketing teams to ensure continuous improvement in recruitment performance.
- Monitor KPIs, budgets, and timelines to proactively address risks and remove roadblocks .
- Represent the voice of the customer internally, advocating for site and sponsor needs in product roadmap discussions.
What Were Looking For
- 6+ years of experience in clinical operations, clinical trial management, or patient recruitment (biotech, pharma, CRO, or site network).
- Proven track record of leading high-performing teams in a fast-paced, customer-facing environment.
- Analytical rigor: you aren't afraid of crunching data for your own insights, creating your own dashboards, or cracking open a SQL query
- Deep understanding of site workflows, sponsor priorities, and recruitment challenges in clinical trials.
- Strong operational mindset able to design scalable systems while maintaining attention to detail.
- Exceptional communication skills and a consultative approach to customer relationships.
- Comfort navigating ambiguity and thriving in a high-growth startup environment .
Why Youll Love Working Here
- Mission-driven culture focused on making clinical trials more accessible for everyone.
- High-growth environment with opportunities to shape the companys future.
- Competitive compensation, equity, and benefits.
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Senior Clinical Operations Lead
Posted 2 days ago
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Join to apply for the Senior Clinical Operations Lead role at Jobright.ai
1 day ago Be among the first 25 applicants
Join to apply for the Senior Clinical Operations Lead role at Jobright.ai
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Job Summary:
Roche is dedicated to advancing science and ensuring access to healthcare for everyone. The Clinical Operations Lead will drive planning, development, and delivery of evidence generation programs, ensuring compliance with US FDA regulations and managing program budgets and timelines.
Responsibilities:
Ensure proactive alignment with LCT (Life Cycle Teams) / PT (Project Teams), medical/clinical, evidence generation and execution strategies within CDMA
Drive planning, development and delivery of evidence generation programs that meet US FDA and IVDR requirements, with full accountability for the program progress, budgets, timelines, strategic scenario assessments, proactive program risk management in partnership with cross-functional stakeholders including LCT Project Leads, Regulatory Affairs, R&D (Research & Development), Diagnostics Partners and other CDMA chapters.
Provide oversight of programs and respective studies to ensure compliance with US FDA regulations
Drive the development of the Integrated Evidence Generation Plan for products in scope and in partnership with internal and external stakeholders while applying applicable US FDA regulations for trial registrations within the US
In collaboration with the Functional Partner (FP) and Sub-Chapter Leads (SCL), ensure adequate allocation of resources by timely communication of demands and skill set requirements in alignment with priorities of the respective CDMA Networks and Project Teams
May be nominated as Functional Partner acting as the key strategic partner for LCTs (primary interface of CDMA and LCTs) with subject matter expertise, providing guidance for priority, budgets and capacity coordination within chapter and/or sub-chapter; enabling the joint CDMA delivery on the LCT strategy and collaborating with CDMA Network, Indication Leads and CDMA Chapters to align strategic decisions at the CA LT (Customer Areas Leadership Teams) and SPC (Solution Portfolio Committee).
Accountable for the oversight of program-level budget of assigned programs
Qualifications:
Required:
Drive patient and customer-centricity (mindset, behaviors and actions) by always putting the needs of patients and the customers first.
Partner across diverse regions, cultures, and time zones to create an environment of belonging, inclusion and diversity
Working across Clinical Development and Medical Affairs communities to identify mutual value and opportunities for collaboration
Demonstrate flexibility and adaptability to perform in a fast-paced, matrixed environment where fluid, cross-team collaboration is crucial
Leverage excellent verbal and written communication skills (English)
Model Roches values of integrity, courage, and passion and operating principles (culture, mindset and behaviors) in everything you do
Company:
Roche is a pharmaceutical and diagnostics company that offers medicines and diagnostic tests for various medical conditions and diseases. Founded in 1896, the company is headquartered in Basel, Basel-Stadt, CHE, with a team of 10001+ employees. The company is currently Public Company. Roche has a track record of offering H1B sponsorships.
Seniority level- Seniority level Mid-Senior level
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- Job function Product Management
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#J-18808-LjbffrClinical Operations Project Manager
Posted 20 days ago
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Job Description
Clinical Operations Project Manager
School of Medicine, Stanford, California, United States
Schedule: Full-time
Job Code: 4104
Employee Status: Regular
Grade: G
Requisition ID: 92550
Please note this position will be based on the Stanford campus and is a hybrid (working on-site no less than 2 days a week and working from home) subject to operational need.
Are you interested in being part of a dynamic team that is growing? Do you like to learn new things and be part of a group looking for solutions? Then please apply for our open Project Manager position!
The Department of Emergency Medicine is looking for a Project Manager that will lead the Clinical Operations team to implement Precision Emergency Medicine. This position will inspire and align the leadership team in all projects that may include, creating predictive models, driving strategy quality improvement processes and the creation of sustainable models. The Department of Emergency Medicine is committed to innovation and inclusion and our expanding clinical operations which is a core pillar of our five-year strategic plan. The Project Manager has an important role in supporting this effort.
Duties include:
- Act on behalf of the supervisor, department manager, or chair in regards to establishing priorities and identifying and resolving problems that are administrative in nature.
- Research and/or write background information for meetings. Participate in meetings on supervisor's behalf, inform after the fact.
- Oversee and/or perform duties associated with scheduling, organizing, and operating complex conferences, seminars, and events, including arranging with vendors for services, overseeing the production and distribution of materials, administering logistics, and managing events within budget.
- Compose and draft documents and correspondence for presentations, course handouts, grants, conferences, seminars, and reports; perform substantial research editing and fact checking. Create, maintain, modify, and/or ensure accuracy of content in various unit documents, displays, reports, brochures, social media, and/or websites.
- Plan and schedule calendar(s) without prior consultation, resolve calendaring conflicts, and arrange travel in compliance with unit, university, and sponsor policies.
- Create complex reports and spreadsheets which may utilize specialized software and systems. Make recommendations based on reports.
- Oversee and/or process a variety of complex financial transactions; produce, monitor, and reconcile budget statements; research, identify, and resolve discrepancies. May assist with capital or special equipment requests and/or vendor selection.
- Coordinate complex office moves. Plan and coordinate routine remodeling and renovations.
- Analyze and review material and extract pertinent information for briefing purposes.
- Lead the administrative functions of the program.
DESIRED QUALIFICATIONS:
Ability to manage, analyze, and synthesize information based on large data sets; Previous project management experience preferred
EDUCATION & EXPERIENCE (REQUIRED):
High school diploma and six years of administrative experience, or combination of education and relevant experience.
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
- Advanced computer skills and demonstrated experience with office software and email applications.
- Proven success in following through and completing projects.
- Excellent organizational skills and attention to detail.
- Excellent verbal and written communication skills.
- Excellent customer service and interpersonal skills.
- Ability to prioritize, multi-task, and assign work to others.
- Ability to take initiative and ownership of projects.
- Ability to routinely and independently exercise sound judgment in making decisions.
- Constantly perform desk-based computer tasks.
- Frequently sitting.
- Occasionally stand/walk, reach/work above shoulders, grasp lightly/fine manipulation, grasp forcefully, use a telephone, sort/file paperwork or parts, lift/carry/push/pull objects that weigh up to 10 pounds.
- Rarely twist/bend/stoop/squat, kneel/crawl.
WORK STANDARDS:
- Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations.
- Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned.
- Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University's Administrative Guide,
As an organization that receives federal funding, Stanford University has a COVID-19 vaccination requirement that will apply to all university employees, including those working remotely in the United States and applicable subcontractors. To learn more about COVID policies and guidelines for Stanford University Staff, please visit:
The job duties listed are typical examples of work performed by positions in this job classification and are not designed to contain or be interpreted as a comprehensive inventory of all duties, tasks, and responsibilities. Specific duties and responsibilities may vary depending on department or program needs without changing the general nature and scope of the job or level of responsibility. Employees may also perform other duties as assigned.
Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job.
Stanford is an equal employment opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law.
To be considered for this position please visit our web site and apply on line at the following link:
Stanford is an equal opportunity employer and all qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law.
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Temp Associate Director, Clinical Operations Excellence
Posted today
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Job Description
Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit high-value frontier targets in RAS-addicted cancers. The company's R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. As a new member of the Revolution Medicines team, you will join other outstanding professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.
Revolution Medicines is seeking a Temporary Associate Director, Clinical Operations Compliance & Training, who will play a key role within Clinical Operations and is responsible for providing compliance support for RevMed sponsored clinical trials with respect to RevMed's Standard Operating Procedures, Good Clinical Practice (GCP), applicable regulatory requirements, and current industry standards and practices.
- SME for Clinical Operations personnel for issues relating to GCP, best practices, SOPs, non-compliance, etc.
- Support Clinical Operations Inspection Readiness initiatives.
- Support the development, revision, and continuous improvement of Clinical Operations SOPs, Work Instructions/Policies in compliance with GCP, RevMed standards, and regulatory requirements.
- Contribute to the development and execution of Clinical Operations training programs.
- Other assigned Clinical Operations activities, as appropriate.
Required Skills, Experience and Education:
- RN or bachelor's or master's degree in biological sciences or health-related field required.
- 10+ years in GCP Quality Assurance, Clinical Compliance, and/or Clinical Operations experience in the pharmaceutical or biotech industry.
- Strong working knowledge of FDA Regulations, ICH Guidelines, and GCP
- Strong background in Inspection Readiness activities.
- Demonstrated experience developing and authoring Clinical and cross-functional SOPs.
- Outstanding organizational skills with the ability to multi-task and prioritize.
- Excellent interpersonal, verbal, and written communication skills, with ability to interact with colleagues and partners at all levels of experience.
- Comfortable in a fast-paced company environment and able to adjust workload based upon changing priorities.
- Demonstrated proficiency in Microsoft Office Suite (Outlook, MS Word, Excel, PowerPoint, Visio); MS Project and/or Smartsheet a plus.
- Travel may be required (~25%).
Preferred Skills:
- Oncology experience, early and/or late stage preferred.
- Strong working knowledge of ex-US regulations and requirements
This is a contract position that will be employed through a third-party recruiting agency. The agency will provide the pay range, which will be based on several factors, including job-related skills, experience, market conditions, and relevant education or training.
Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition, and veteran status.
Revolution Medicines takes the protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy.
Associate Director, Clinical Operations Compliance & Training
Posted 4 days ago
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1 day ago Be among the first 25 applicants
This range is provided by Bayside Solutions. Your actual pay will be based on your skills and experience talk with your recruiter to learn more.
Base pay range$85.00/hr - $5.00/hr
Associate Director, Clinical Operations Compliance & Training
W2 Contract-to-Hire
Salary Range: 176,800 - 197,600 per year
Location: Redwood City, CA - Onsite Role
Job Summary:
We are seeking a Temporary Associate Director, Clinical Operations Compliance & Training, who will play a key role within Clinical Operations and is responsible for providing compliance support for the sponsored clinical trials with respect to the standard Operating Procedures, Good Clinical Practice (GCP), applicable regulatory requirements, and current industry standards and practices.
Duties and Responsibilities:
- SME for Clinical Operations personnel for issues relating to GCP, best practices, SOPs, non-compliance, etc.
- Support Clinical Operations Inspection Readiness initiatives.
- Support the development, revision, and continuous improvement of Clinical Operations SOPs, Work Instructions/Policies in compliance with GCP and regulatory requirements.
- Contribute to the development and execution of Clinical Operations training programs.
- Other assigned Clinical Operations activities, as appropriate.
Requirements and Qualifications:
- RN or bachelor's or master's degree in biological sciences or a health-related field required.
- 10+ years in GCP Quality Assurance, Clinical Compliance, and/or Clinical Operations experience in the pharmaceutical or biotech industry.
- Strong working knowledge of FDA Regulations, ICH Guidelines, and GCP
- Strong background in Inspection Readiness activities.
- Demonstrated experience developing and authoring Clinical and cross-functional SOPs.
- Outstanding organizational skills with the ability to multitask and prioritize.
- Excellent interpersonal, verbal, and written communication skills, with the ability to interact with colleagues and partners at all levels of experience.
- Comfortable in a fast-paced company environment and able to adjust workload based on changing priorities.
- Demonstrated proficiency in Microsoft Office Suite (Outlook, MS Word, Excel, PowerPoint, Visio); MS Project and/or Smartsheet a plus.
- Travel may be required (~25%)
Preferred Qualifications:
- Oncology experience, early and/or late stage preferred.
- Strong working knowledge of ex-US regulations and requirements
Desired Skills and Experience
Clinical Operations Compliance, Clinical Operations Training, Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), FDA Regulations, ICH Guidelines, Regulatory Compliance, Inspection Readiness, Quality Assurance, Clinical Trials Management, SOP Development, SOP Authoring, Work Instructions Development, Clinical Operations Best Practices, Training Program Development, Pharmaceutical Industry Experience, Biotech Industry Experience, GCP Compliance, Regulatory Requirements, Cross-functional SOPs, Clinical Compliance, Microsoft Office Suite, MS Word, Excel, PowerPoint, Visio, MS Project, Smartsheet, Organizational Skills, Multitasking, Priority Management, Written Communication, Verbal Communication, Interpersonal Skills, Oncology Clinical Trials, Early Stage Clinical Trials, Late Stage Clinical Trials, Ex-US Regulations, International Regulatory Requirements, Healthcare Compliance, Clinical Research, Process Improvement, Continuous Improvement, Policy Development, Stakeholder Management, Team Collaboration
Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate.
Bayside Solutions, Inc. may collect your personal information during the position application process. Please reference Bayside Solutions, Inc.'s CCPA Privacy Policy at .
Seniority level- Seniority level Not Applicable
- Employment type Contract
- Job function Research and Science
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#J-18808-LjbffrSenior Director, Clinical Operations (Redwood City)
Posted 3 days ago
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Job Description
Arcellx isa public, clinical-stage biotechnology company reimagining cell therapy by engineering innovative immunotherapies for patients with cancer and other incurable diseases. We believe that cell therapies are one of the forward pillars of medicine and our mission is to destroy cancer and advance humanity by developing cell therapies that are safer, more effective, and more broadly accessible.
Our team members are made up of talented innovators and dreamers working from our offices in Rockville, Maryland, and Redwood City, California. At Arcellx, we hire exceptional people and create a fun, diverse, supportive, and informal environment that allows everyone to do their best work.
What Matters to Us
Living our core values is essential to maintaining a work environment that is high-performing, inclusive, and collaborative. We look for candidates who demonstrate strong values alignment and bring different backgrounds, viewpoints, and abilities to the team.
Arcellx Core Values
- Character : Committed to always doing whats right.
- Audacity : Willing to challenge convention and share candid feedback with others.
- Determination : Curious and self-motivated. Always looking to improve and learn.
- Collaboration : No job is too small mentality. Humble and willing to help others.
- Originality : Will bring your unique perspective to the table and respect a diverse set of views and backgrounds.
How Youll Make a Difference
As our clinical operations leader, youll drive the successful execution of our clinical trials, including overseeing our internal team members and CROs. This individual will be accountable for providing strategic operational leadership including expertise and oversight over one or more clinical programs driving financial planning/forecasting, resource and budget planning and management, and development and implementation of department initiatives. This role plays a critical part in advancing our trials and getting our potentially life-saving therapy to patients.
The Fine Print What Youll Do
- Own program oversight including identification and mitigation of risks to study implementation, enrollment, quality oversight and study completion.
- Lead and mentor direct and indirect reports. Identify, recruit, hire, and develop top talent.
- Evaluate and manage CROs and other service providers; serve as point of escalation and program representative.
- Oversees selection, contracting, performance and budget-related activities for vendors and clinical trial sites.
- Oversees and coordinates all budgetary activities for assigned programs.
- Plans and implements quality checks for multiple clinical trials.
- Provides technical expertise for the development of clinical documents.
Skills and Experience We Look For
- Minimum BA/BS in scientific or health-related field.
- Minimum of 12 years of oncology clinical operations experience in the pharmaceutical/biotech industry.
- Strong working knowledgeable of GCP/ICH guidelines.
- Excellent leadership, organizational, and communication skills.
- Experienced using Microsoft Office applications (Word, Excel, PowerPoint, etc.).
Rewards at Arcellx
Our people are our greatest asset, and supporting their well-being is an essential part of delivering on our mission and impacting the lives of patients. Putting this belief into practice means offering strong compensation and benefits.
The estimated base salary range for this position is $265,000 - $295,000 per year. Where a candidate falls within that range is determined by factors such as years of experience. Our compensation package also includes an annual bonus based on company goals and an equity (RSU) grant. We do offer relocation assistance for roles if required.
Our market-leading benefits package includes: 100% coverage for medical, dental and vision for team members and dependents, unlimited vacation, a 3-day weekend every month, fully-paid parental leave for up to 6 months, tuition reimbursement, 401k employer contribution and more.
Join us in our quest to reimagine cell therapy and destroy cancer. For more on our technology, culture, and team, go to .
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#J-18808-LjbffrAssociate Director, Clinical Operations (Redwood City)
Posted 11 days ago
Job Viewed
Job Description
Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The companys R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. As a new member of the Revolution Medicines team, you will join other outstanding Revolutionaries in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.
The Opportunity:
This is a unique opportunity for a Clinical Operations Professional who has innate leadership and organizational skills, technical expertise in clinical oncology drug development in an industry setting, and experience in overseeing clinical trials. As an Associate Director, you will be responsible for the Contract Research Organization (CRO) oversight, execution, and management of Revolution Medicines (RevMed) clinical trials.
Adhere to Clinical Standard Operating Procedures (SOP) and Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) Guidelines.
Be a team leader, providing guidance and oversight for the successful management of all aspects of clinical trials within timelines and designated program budgets.
Review and comment on the development, management, and execution of the Clinical Development Plan (CDP) for assigned clinical programs which includes timelines, budget, and resource requirements. Ability to identify critical path activities and articulate and mitigate risks to clinical trial conduct.
Responsible for successful planning and deployment of Clinical Operations staff (potentially including Clinical Program Managers/Clinical Trial Managers/Clinical Trial Assistants, and consultants) for project and non-project related tasks.
Line management responsibilities include hiring, performance management, career development, and mentorship.
Manage/oversee CROs and selected study vendors; ensuring all vendors strive to achieve the predetermined program milestones according to budget and timeline, as well as evaluate vendor performance using metrics and key performance indicators (KPIs).
Able to pivot, be solution-oriented with consideration to long-term impact on clinical trials, responsibilities, and inspection-readiness.
Participate in team meetings and collaborate with other functional groups within the company (e.g., Clinical Development, Regulatory, Quality Assurance, Finance, Legal, etc.) to achieve clinical study goals.
Ensure clinical trials maintain an inspection readiness state throughout the lifecycle of the trial.
Partner with Clinical Operations team members and functional peers to improve process that willimpact clinical trial management and deliverables including contingency plans.
Required Skills, Experience and Education:
Bachelors degree in biological sciences or health-related field required.
10+ years direct Clinical Operations experience in the pharmaceutical or biotech industry. Relevant indirect experiences may also meet the requirement.
Minimum of 4 years of project and line management experience.
Extensive experience in leading and managing global phase 1-3 clinical trials within designated timelines, resources, and budgets.
Strong working knowledge of FDA Regulations, ICH Guidelines, and GCP.
Experience with vendor management and CRO oversight.
Ability to perform complex analysis, draw relevant conclusions, and implement appropriate solutions.
Strong analytical, negotiation, and persuasion skills.
Ability to deal with time demands, incomplete information, or unexpected events.
Outstanding organizational skills with the ability to multi-task and prioritize.
Excellent interpersonal, verbal, and written communication skills.
Decision-making skills.
Comfortable in a fast-paced company environment and able to adjust workload based upon changing priorities.
Demonstrate proficiency in Microsoft Office Suite (Outlook, MS Word, Excel, PowerPoint); MS Project and/or Smartsheet a plus.
Travel may be required (~25%).
Preferred Skills:
RN or Masters degree in biological sciences or health-related field preferred.
Has familiarity working with vendor systems/portals (e.g., eTMF, EDC, IRT, CTMS).
Oncology experience, early and/or late stage, strongly preferred.
Knowledge and/or familiarity with Ex-US region(s) clinical trial operations.
Experience in working with cooperative group studies and investigator sponsored trials, preferred.
The base salary range for this full-time position is $180,000 to $225,000 for candidates working onsite at our headquarters in Redwood City, CA. The range displayed on each job posting is intended to be the salary for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our salary ranges are determined by role, level, and location. Individual pay is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.
Please note that base salary is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.
Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition, and veteran status.
Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with ourCCPA Notice andPrivacy Policy .For additional information, please contact .
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Senior Clinical Program Manager, Clinical Operations
Posted 1 day ago
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Job Description
Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. As a new member of the Revolution Medicines team, you will join other outstanding professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.
The Opportunity:
This is a unique opportunity for a Clinical Operations Professional. As a Sr. Clinical Program Manager, you will be responsible for acting as a central contact for the Clinical Study Team(s) and assist with the execution and management of Revolution Medicines (RevMed) clinical trials.
Responsibilities:
- Adhere to Clinical Standard Operating Procedures (SOP), Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) Guidelines.
- Be a team leader, providing guidance and oversight for the successful management of all aspects of clinical trials within timelines and designated program budgets.
- Partner with cross-functional teams to manage, adjust, and revise project timelines and budgets as needed.
- Analyze data health metrics to be shared with stakeholders.
- Actively partner with cross-functional teams and vendors to drive the query resolution and data listings review process to meet objectives in a timely and efficient process.
- Conduct risk management, contingency, and scenario planning.
- Supervise, communicate project status/issues, and problem solve to ensure project team goals are met.
- Participate in the development of all study-related documentation, including study protocols.
- Actively contributes in the selection and management of contract research organizations (CROs) and/or vendors, including development of requests for proposals (RFPs).
- Use all available tools to track, oversee, and communicate on program status to all key stakeholders.
- Demonstrate the ability to lead and manage multiple complex clinical trials within one or multiple programs with limited oversight.
- Independently lead Clinical Study Execution Team (CSETs) and influence relevant stakeholders both internally and externally including management.
- May lead interdepartmental strategic business initiatives as well as spearhead certain SOP development and training.
- May provide input into strategic and operational short- and long-term therapeutic area development, as appropriate, including supporting alignment and communication to other team members upon implementation.
- Assists in the hiring, development, and retention of top talent within the team. Coaches direct report(s) on their performance, development, and career interests.
- Participate in other Clinical Operations activities as appropriate.
Required Skills, Experience and Education:
- RN or Bachelor's or Masters degree in biological sciences or health-related field required
- 10+ years direct Clinical Operations experience in the pharmaceutical or biotech industry, preferably in Clinical Operations or Clinical Research-related experience. Relevant indirect experiences may also meet the requirement.
- Minimum of 6 years of cross-functional study management or related leadership experience in life sciences, including multiple years' experience managing project teams
- Strong working knowledge of FDA Regulations, ICH Guidelines, and GCP
- Proven ability to successfully start-up, manage, and close-out clinical trials, including authoring clinical study and regulatory documentation and SOPs.
- Experience in selection of CROs/vendors and management of external resources
- Thrives in a collaborative team setting that demonstrates flexibility required to maintain a fast pace and is driven by a desire to deploy innovative approaches and technologies in a high-energy environment
- Be solution-oriented by anticipating obstacles and difficulties, and proactively providing risk assessment and mitigation strategies to achieve project goals.
- Excellent written/verbal communication and interpersonal skills.
- High sense of priority and commitment to excellence in the successful execution of deliverables.
- Ability to analyze operational data, contribute with a mind on quality, timeliness and fiscal responsibility, make and drive decisions, multi-task, prioritize tasks, anticipate challenges, and execute on goals as a member of an interdisciplinary team.
- Demonstrate proficiency in Microsoft Office Suite (Outlook, MS Word, Excel, PowerPoint); MS Project and/or Smartsheet a plus.
- Travel may be required (~25%).
Preferred Skills:
- Familiarity working with vendor systems/portals (e.g., eTMF, EDC, IRT, CTMS).
- Oncology experience, early and/or late stage, strongly preferred.
- Knowledge and/or familiarity with Ex-US region(s) clinical trial operations.
- Some experience managing direct reports.
The base salary range for this full-time position is $158,000 to $198,000 for candidates working onsite at our headquarters in Redwood City, CA. The range displayed on each job posting is intended to be the salary for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our salary ranges are determined by role, level, and location. Individual pay is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.
Please note that base salary is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.
Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition, and veteran status.
Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone.
Clinical Trials Manager, Clinical Operations-Inflammation
Posted 1 day ago
Job Viewed
Job Description
Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
**Job Description**
**POSITION OVERVIEW:**
Clinical Operations is responsible for the worldwide execution of all Phase I - IV clinical trials across all Gilead therapeutic areas. Clinical Operations plays a key role in ensuring all Gilead clinical trials are performed in accordance with applicable SOPs, company policies and regulatory guidelines to provide timely and high-quality clinical data that supports global registration and commercialization of Gilead's products.
You will manage a geographical region(s) of assigned clinical studies or multiple components of larger studies. You will typically manage Phase I studies or other smaller studies. You will define and incorporate study logistics and study plans to accomplish clinical study objectives. You may also participate in strategic initiatives.
**EXAMPLE RESPONSIBILITIES:**
+ Manages all components of small clinical studies, including Phase I studies.
+ With guidance, may lead contract research organization (CRO) and vendor selection and, where applicable, manages all interactions and deliverables from relevant CROs and vendors.
+ Typically serves as the key operational contact for Gilead studies; providing oversight for the site evaluation, initiation, and close-out visits in addition to routine monitoring visits, either directly or through CROs.
+ Defines and develops the study logistics and clinical study plan for assigned clinical studies.
+ Manages study timelines, including documentation and communications.
+ Participates in and manages project meetings and conference calls with CROs, other vendors and cross-functional teams.
+ Contributes to SOP development and/or participates in special projects. Develops tools and processes that optimize project efficiencies and effectiveness.
+ Provides input into study protocols and case report forms, authors informed consents, study plans, and presentations.
+ Provides oversight of study sites/region and reviews routine regulatory documents to ensure that CROs are in compliance with protocols, regulatory requirements, SOPs, and monitoring plans.
+ May be required to present at internal or external meetings (i.e., investigator meetings).
+ Leads or otherwise assists in the preparation of safety, interim and final study reports, including resolving any data discrepancies.
+ Proactively identifies potential operational challenges and collaborates with other Clinical Operations' colleagues to provide solutions to ensure study execution remains on track to defined protocols, budgets and timelines.
+ Assists in training new or less experienced colleagues.
+ Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements.
**REQUIREMENTS:**
We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.
**Minimum Education & Experience**
+ PharmD / PhD with 2+ years' relevant clinical or related experience in life sciences.
+ MA / MS with 3+ years' relevant clinical or related experience in life sciences.
+ BA / BS / RN with 5+ years' relevant clinical or related experience in life sciences.
+ Multiple years' clinical or related experience in life sciences, including experience leading or managing less complex studies and project teams.
+ Experience managing the work of external vendors.
**Knowledge & Other Requirements**
+ Demonstrated ability to be a fast learner.
+ Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed.
+ Ability to manage any component of full cycle study management, from start-up to close-out.
+ Advanced knowledge of study management best practices and tools and has shown ability to apply these to improve study efficiencies and effectiveness.
+ Fully understands protocol requirements and effectively articulates and interprets these.
+ Thorough knowledge of Food & Drug Administration (FDA), European Medicines Agency (EMA), and other applicable national regulations, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines and Good Clinical Practice (GCP) governing the conduct of clinical studies.
+ Familiar with standard medical / scientific terminology.
+ Ability to communicate in a clear and concise manner.
+ Ability to support a team-oriented, highly-matrixed environment.
+ Ability to execute multiple tasks as assigned.
+ When needed, ability to travel.
The salary range for this position is: $146,540.00 - $189,640.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit:
Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
**For jobs in the United States:**
Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' ( poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT ( RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
PAY TRANSPARENCY NONDISCRIMINATION PROVISION ( environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
**For Current Gilead Employees and Contractors:**
Please apply via the Internal Career Opportunities portal in Workday.
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
Associate Director, Clinical Operations Compliance & Training (Redwood City)
Posted 11 days ago
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Job Description
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The Opportunity
Seeking a Associate Director, Clinical Operations Compliance & Training (contractor), who will play a key role within Clinical Operations and is responsible for providing compliance support for sponsored clinical trials with respect to Standard Operating Procedures, Good Clinical Practice (GCP), applicable regulatory requirements, and current industry standards and practices.
- SME for Clinical Operations personnel for issues relating to GCP, best practices, SOPs, non-compliance, etc.
- Support Clinical Operations Inspection Readiness initiatives.
- Support the development, revision, and continuous improvement of Clinical Operations SOPs, Work Instructions/Policies in compliance with GCP, company standards, and regulatory requirements.
- Contribute to the development and execution of Clinical Operations training programs.
- Other assigned Clinical Operations activities, as appropriate.
The Opportunity
Seeking a Associate Director, Clinical Operations Compliance & Training (contractor), who will play a key role within Clinical Operations and is responsible for providing compliance support for sponsored clinical trials with respect to Standard Operating Procedures, Good Clinical Practice (GCP), applicable regulatory requirements, and current industry standards and practices.
- SME for Clinical Operations personnel for issues relating to GCP, best practices, SOPs, non-compliance, etc.
- Support Clinical Operations Inspection Readiness initiatives.
- Support the development, revision, and continuous improvement of Clinical Operations SOPs, Work Instructions/Policies in compliance with GCP, company standards, and regulatory requirements.
- Contribute to the development and execution of Clinical Operations training programs.
- Other assigned Clinical Operations activities, as appropriate.
- RN or bachelors or masters degree in biological sciences or health-related field required.
- 10+ years in GCP Quality Assurance, Clinical Compliance, and/or Clinical Operations experience in the pharmaceutical or biotech industry.
- Strong working knowledge of FDA Regulations, ICH Guidelines, and GCP
- Strong background in Inspection Readiness activities.
- Demonstrated experience developing and authoring Clinical and cross-functional SOPs.
- Outstanding organizational skills with the ability to multi-task and prioritize.
- Excellent interpersonal, verbal, and written communication skills, with ability to interact with colleagues and partners at all levels of experience.
- Comfortable in a fast-paced company environment and able to adjust workload based upon changing priorities.
- Demonstrated proficiency in Microsoft Office Suite (Outlook, MS Word, Excel, PowerPoint, Visio); MS Project and/or Smartsheet a plus.
- Travel may be required (~25%)
- Oncology experience, early and/or late stage preferred.
- Strong working knowledge of ex-US regulations and requirements
Seniority level
- Seniority level Not Applicable
- Employment type Full-time
- Job function Research, Analyst, and Information Technology
- Industries Staffing and Recruiting
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