Current jobs related to Senior Manager of Clinical Trials - South San Francisco, California - Structure Therapeutics
-
Senior Clinical Trial Manager
7 days ago
South San Francisco, California, United States Allogene Therapeutics Full timeAbout Allogene Therapeutics:Allogene Therapeutics is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T) products for cancer and autoimmune disease. Our mission is to deliver life-changing products for patients.The Role:The Senior Clinical Trial Manager will be responsible for the...
-
Senior Clinical Trial Manager
2 days ago
South San Francisco, California, United States Allogene Therapeutics Full timeAbout Allogene Therapeutics:Allogene Therapeutics is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T) products for cancer and autoimmune disease.Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of "off-the-shelf" CAR T cell...
-
Senior Clinical Trial Manager
3 days ago
South San Francisco, California, United States Allogene Therapeutics Full timeAbout Allogene Therapeutics:Allogene Therapeutics is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T ) products for cancer and autoimmune disease.Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of off-the-shelf CAR T cell...
-
Senior Clinical Trial Manager
3 weeks ago
South San Francisco, California, United States BioSpace, Inc. Full timeJob DetailsAlumis Inc. is a precision medicines company with a mission to transform the lives of patients with autoimmune diseases. Despite treatment innovations over the last two decades, many patients with immunologic conditions continue to suffer. Our goal is to fundamentally change the outcomes for these patients.We are seeking an experienced Senior...
-
Senior Clinical Trial Manager
6 days ago
South San Francisco, California, United States Structure Therapeutics Full timeJob SummaryStructure Therapeutics is seeking a highly motivated Senior Clinical Trial Manager to join our Clinical Operations team. As a key member of our team, you will be responsible for the day-to-day oversight of global clinical trials, managing internal stakeholders, CROs, and clinical trial sites. This is a unique opportunity to join a growing company...
-
Senior Clinical Trials Management Associate
2 weeks ago
South San Francisco, California, United States Planet Pharma Full timeJob Title: Senior Clinical Trials Management AssociateJoin Planet Pharma as a Senior Clinical Trials Management Associate and contribute to the success of our clinical trials. As a key member of our team, you will be responsible for supporting all aspects of clinical trial conduct, including study start-up, enrollment, study conduct, and close-out.Key...
-
Senior Clinical Trial Manager
1 month ago
San Francisco, California, United States Meet Full timeSenior Clinical Trials Manager - Oncology ResearchMeet a rapidly growing biotech company focused on developing innovative oncology treatments. This company fosters a collaborative environment, allowing for high levels of professional growth and development. The team is seeking an experienced Senior Clinical Trials Manager to lead their clinical trials,...
-
Senior Clinical Trials Manager
1 week ago
South San Francisco, California, United States Cytokinetics Full timeJob PurposeCytokinetics is a leading biopharmaceutical company focused on developing innovative treatments for debilitating diseases affecting cardiac muscle performance. As a key player in muscle biology, the company is pioneering first-in-class muscle activators and next-in-class muscle inhibitors.The Senior Clinical Trials Manager will oversee the...
-
Senior Clinical Trial Manager
1 week ago
South San Francisco, California, United States Pliant Therapeutics, Inc. Full timeJob SummaryThe Senior Clinical Trial Manager is responsible for managing the day-to-day operations of assigned clinical studies to ensure completion per established project team goals and objectives. This is a hybrid position, with a 3 day in the office expectation (South San Francisco).Key ResponsibilitiesLead internal cross-functional study team for...
-
Senior Clinical Trial Manager
4 weeks ago
South San Francisco, California, United States Pliant Therapeutics Full timeAbout Pliant TherapeuticsPliant Therapeutics is a late-stage biopharmaceutical company dedicated to discovering and developing novel therapies for fibrotic diseases. Founded by Third Rock Ventures with world-renowned academic thought leaders, Pliant is committed to raising the bar to meet the unmet medical needs of physicians, patients, and families impacted...
-
Clinical Trial Manager
2 weeks ago
South San Francisco, California, United States Structure Therapeutics Full timeJob Title: Senior Clinical Trial ManagerStructure Therapeutics is seeking a highly motivated Senior Clinical Trial Manager to join our Clinical Operations team. As a key member of our team, you will be responsible for the day-to-day oversight of global clinical trials and will manage internal stakeholders, CROs, multiple service providers, clinical monitors,...
-
Senior Clinical Trial Manager, LUMUS Program
2 days ago
South San Francisco, California, United States BioSpace, Inc. Full timeSenior Clinical Trial Manager, LUMUS ProgramAlumis Inc. is a precision medicines company dedicated to transforming the lives of patients with autoimmune diseases. We are seeking an experienced Senior Clinical Trial Manager to join our LUMUS study team.LUMUS Study OverviewThe LUMUS study is a global, Phase 2 trial aimed at evaluating the efficacy, safety, and...
-
Senior Clinical Trial Associate
1 month ago
South San Francisco, California, United States Meet Full timeJob SummaryWe are seeking a highly skilled and experienced Senior Clinical Trial Associate to join our Clinical Operations team. As a key member of our team, you will play a critical role in supporting the successful execution of clinical trials.Key ResponsibilitiesConduct site feasibility assessments and recruitment efforts, ensuring timely and accurate...
-
Senior Clinical Trial Manager
1 week ago
South San Francisco, California, United States Assembly Biosciences, Inc. Full timeJob Title: Senior Clinical Trial ManagerAssembly Bio is seeking a highly motivated and experienced Senior Clinical Trial Manager to lead innovative clinical study trials from startup through closedown.This is a challenging and rewarding role that requires a strong understanding of clinical operations, regulatory compliance, and project management.The...
-
Senior Clinical Trial Management Associate
1 week ago
South San Francisco, California, United States Arsenal Biosciences Full timeTransformative Opportunities AheadJoin Arsenal Biosciences, a clinical-stage programmable cell therapy company, in our mission to defeat cancer. As a Senior Clinical Trial Management Associate, you will play a critical role in driving the future of medicine hand in hand with Technical Operations to guarantee top-tier drug quality and timely delivery.Key...
-
Senior Clinical Trial Associate
2 weeks ago
South San Francisco, California, United States Meet Full timeJob SummaryWe are seeking a highly skilled Senior Clinical Trial Associate to join our team. As a key member of our Clinical Operations team, you will play a critical role in supporting the successful execution of clinical trials.Key ResponsibilitiesConduct site feasibility assessments and recruitment efforts, ensuring the highest quality of clinical...
-
Clinical Trial Manager
4 weeks ago
South San Francisco, California, United States Alumis Full timeJob Title: Clinical Trial ManagerAlumis Inc. is a precision medicines company dedicated to transforming the lives of patients with autoimmune diseases. As a Clinical Trial Manager at Alumis, you will play a key role in supporting the Clinical Operations team across the full spectrum of study activities, including site activation, patient recruitment, study...
-
Senior Clinical Trial Manager, LUMUS Program
4 days ago
South San Francisco, California, United States BioSpace, Inc. Full timeJob DetailsAt BioSpace, Inc., we are seeking an experienced Senior Clinical Trial Manager to join our LUMUS study team. The LUMUS study is a global, Phase 2 trial aimed at evaluating the efficacy, safety, and pharmacokinetics of our targeted Tyrosine Kinase 2 (TYK2) inhibitor therapy in adult patients with moderately to severely active, autoantibody-positive...
-
Senior Clinical Trial Manager, LUMUS Program
2 days ago
South San Francisco, California, United States BioSpace, Inc. Full timeJob DetailsAlumis Inc. is a precision medicines company with a mission to transform the lives of patients with autoimmune diseases. Our goal is to fundamentally change the outcomes for these patients.We are seeking an experienced Senior Clinical Trial Manager to join our LUMUS study team. LUMUS is a global, Phase 2 trial aimed at evaluating the efficacy,...
-
Senior Manager Clinical Trials Lead
4 weeks ago
San Francisco, California, United States Olema Oncology Full timeAbout Olema OncologyOlema Oncology is a pioneering cancer medicines company dedicated to making a meaningful impact on breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a groundbreaking oral medicine known as a complete estrogen receptor antagonist (CERAN) initially in development for metastatic breast cancer. Our pipeline also includes...
Senior Manager of Clinical Trials
2 months ago
Salary: Competitive
Structure Therapeutics is at the forefront of developing transformative therapies for patients through cutting-edge structure-based and computational drug discovery methodologies. Our innovative platform leverages state-of-the-art visualization of molecular interactions, computational chemistry, and data integration to create orally available, superior small molecule therapies that address the limitations of current biologic and peptide treatments. We are advancing a pipeline of clinical-stage therapies targeting chronic diseases with significant unmet needs, including cardiovascular, metabolic, and pulmonary disorders.
Our organization is spearheaded by a team of seasoned drug development professionals and supported by premier global life sciences investors. With a recent initial public offering (IPO), Structure Therapeutics operates from key innovation hubs, maximizing the strengths of both the US and international markets.
POSITION SUMMARY
We are seeking a dedicated Senior Clinical Trial Manager (Sr. CTM) to join our Clinical Operations team. This role presents a unique opportunity to contribute to a dynamic organization focused on converting biologics and peptides into impactful small molecule therapies. The Sr. CTM will oversee the daily management of global clinical trials, coordinating with internal teams, contract research organizations (CROs), various service providers, clinical monitors, and trial sites. The primary focus will be on managing multinational, multicenter Phase II studies, with potential responsibilities for additional studies as required. The Sr. CTM will collaborate closely with the Clinical Development Operations team, receiving objectives and ensuring timely and budget-compliant deliverables.
This position involves working with a cross-functional team to ensure that clinical trials are executed efficiently and in accordance with standard operating procedures (SOPs), ICH/GCP guidelines, regulatory requirements, and company objectives.
KEY RESPONSIBILITIES
- Lead and coordinate global cross-functional study teams throughout all phases of the study lifecycle (initiation, execution, closure).
- Collaborate with internal stakeholders to manage the RFP and RFI processes, evaluate service providers, and negotiate complex agreements.
- Provide oversight to CROs and service providers to ensure accurate coordination of clinical study activities.
- Assist with inspection readiness initiatives, developing and implementing policies to maintain high-quality standards in all study activities.
- Coordinate clinical study timelines with project management and address any issues impacting timelines or deliverables.
- Participate in the development and review of study documents, including CRF design and project plans.
- Recommend changes to SOPs and policies to enhance compliance and operational efficiency.
- Identify potential study risks, escalate as necessary, and propose solutions.
- Manage study sites and related activities, including feasibility assessments, site selection, subject recruitment, and data review.
- Provide regular updates to study leads and stakeholders, proactively managing issues as they arise.
- Collaborate with finance to monitor vendor accruals and budget status.
- Prepare or review clinical sections of regulatory submission documents.
- Monitor study progress for potential changes in scope to ensure timely adjustments.
- Oversee the study budget, including site and service provider costs.
- Facilitate ongoing communication regarding operational issues and provide accurate progress reports.
- Ensure data integrity in study-specific systems (e.g., EDC, CTMS, eTMF).
- Contribute as a subject matter expert on key projects to implement process improvements.
- Perform additional supportive duties as needed to achieve operational goals.
COMMUNICATION & INTERPERSONAL SKILLS
- Exceptional written and verbal communication skills, capable of conveying objectives clearly and maintaining open communication with stakeholders.
- Strong negotiation and project management abilities, with a talent for coordinating across multiple projects and timelines.
- Ability to work effectively in a remote, cross-functional team environment with a positive attitude.
- Proficient in prioritizing and managing multiple tasks while remaining adaptable to changing priorities.
- Exemplify core values: Passion, Integrity, Innovation, and Patient Focus.
CORE COMPETENCIES & REQUIREMENTS
- Proficient in PC applications; MS Office skills (Outlook, Word, Excel, PowerPoint) are essential.
- Comprehensive understanding of FDA and EU regulations, ICH Guidelines, and GCP requirements governing clinical trials.
- Minimum of 3 days a week on-site presence required.
EDUCATION & EXPERIENCE
- Bachelor's degree or equivalent in a scientific or healthcare discipline is preferred.
- 7+ years of experience in a biotech or pharmaceutical setting, leading cross-functional clinical activities with increasing responsibility.
- Minimum of 3 years of study management experience in clinical and drug development, including oversight of outsourced studies.
- Experience in managing sites, CROs, and service providers in global studies is essential.
- Experience with SOP development and implementation is advantageous.
- Experience working on global teams is preferred, particularly in Asia-Pacific and EU regions.
TRAVEL REQUIREMENTS
Willingness to travel up to 30%.
The target salary range for this full-time role is competitive, with additional benefits including bonuses and equity options. Salary ranges are determined based on the level of responsibility and location, with individual compensation further influenced by relevant experience and qualifications.
