Senior Manager of Clinical Operations

2 weeks ago

San Francisco, California, United States BridgeBio Full time
About BridgeBio Pharma

BridgeBio Pharma is dedicated to the discovery and development of innovative therapies for patients suffering from genetic disorders and cancers with identifiable genetic drivers. Our mission is to connect groundbreaking advancements in genetic research with the delivery of impactful treatments to patients. Since our inception, we have cultivated a diverse portfolio of over 30 drug development initiatives, spanning from preclinical to late-stage development across various therapeutic domains, including genetic dermatology, precision oncology, cardiology, endocrinology, neurology, pulmonology, and renal disease.

Who You Are

The Senior Manager of Clinical Operations oversees the operational aspects of designated clinical programs. This role demands a high level of expertise in accordance with the principles and standard practices governing clinical trial operations. You will lead assigned projects and contribute regional insights to global initiatives when relevant. Key responsibilities include managing CRO oversight, training, vendor relationships, and reviewing agreements related to CRO clinical activities. Collaborating with both internal and external stakeholders is essential to ensure seamless operations in clinical activities while upholding high standards in a cross-functional setting.

Key Responsibilities
  • Act as the representative for Clinical Operations on cross-functional study teams and during Vendor and CRO operational meetings, ensuring adherence to global operational standards and protocols.
  • Provide leadership on ClinOps-related matters and inform the management team of potential challenges and solutions.
  • Oversee the review and management of tasks within study monitoring plans and all operational activities associated with clinical trials.
  • Ensure that all components of the trial master file (TMF/eTMF) are current and accurate for assigned investigational trials.
  • Monitor global regulatory intelligence to enhance operational efficiency and compliance with international industry practices.
  • Offer operational guidance to investigators and deliver CRO training pertinent to study conduct.
  • Review study budgets and master ICF templates to facilitate study initiation.
  • Manage inquiries related to clinical studies from CROs and address issues raised by CROs or other service providers.
  • Participate in audits and support regulatory inspections concerning GCP.
  • Ensure consistency in the collection, processing, and evaluation of clinical data.
  • Coordinate and plan for the availability of clinical and non-clinical supplies necessary for trial execution.
  • Contribute to the formulation of ClinOps SOPs and company policies to guarantee compliance with regional regulatory requirements and promote continuous improvements.
  • Represent Clinical Operations on cross-functional teams.
Successful Team Members
  • Champion patient-centric values and uphold high ethical standards.
  • Exhibit an entrepreneurial spirit, driving practical solutions with an ownership mindset.
  • Possess a detail-oriented, rational, and humble approach to problem-solving.
  • Inspire excellence in themselves and those around them.
  • Demonstrate high-quality execution against goals and milestones with precision and speed.
Education, Experience & Skills Requirements
  • Bachelor's degree in a scientific or medical field is required; an advanced degree is preferred.
  • A minimum of eight years of experience in Clinical Operations, collaborating with CROs and other vendors throughout all development stages in the biopharma sector.
  • At least five years of management experience in a clinical research environment.
  • Experience in rare/orphan diseases and pediatric studies is preferred.
  • Proven experience in maintaining a submission-ready eTMF is required.
  • Previous experience in a cross-functional environment is essential.
  • Demonstrated ability to build effective relationships with external vendors and CROs.
  • Exceptional verbal communication skills, facilitating professional guidance for individual and team efforts related to Clinical Operations.
  • Strong negotiation, multi-tasking, organizational, and decision-making skills.
  • Proficiency in databases, coding, data mining methodologies, and Microsoft applications.
  • Comprehensive knowledge of GCP and familiarity with ICH guidelines.
  • Understanding of GDPR and its application in clinical trials.
  • Willingness to travel to regional and global sites.
What We Offer
  • A culture driven by our core values: prioritizing patients, independent thinking, radical transparency, valuing time, and letting science guide our decisions.
  • A decentralized model that empowers program teams to focus on advancing science and supporting patients.
  • A collaborative, fast-paced, data-driven environment that encourages high performance.
  • Access to professional development resources to enhance your career.
  • Competitive compensation and benefits package, including base salary, performance bonuses, equity, health, welfare, and retirement programs.
  • Flexible paid time off.
  • Opportunities for rapid career advancement for high performers.
  • Potential to engage in multiple BridgeBio Pharma programs across various therapeutic areas over time.
  • Commitment to Diversity, Equity & Inclusion.

  • Clinical Operations Manager

    5 days ago

    San Francisco, California, United States Clinical Management Consultants Full time

    Job Summary: Clinical Management Consultants is seeking an experienced Nurse Manager to oversee our Case Management team. As a key member of our clinical operations team, you will be responsible for supervising and supporting case managers, developing patient care plans, coordinating discharge planning, and improving healthcare delivery.Key...

  • Senior Vice President of Clinical Operations

    1 week ago

    San Francisco, California, United States University of California Full time

    Senior Vice President of Clinical OperationsDepartment: Office of the President - Adult ServicesEmployment Type: Full TimeJob SummaryThe University of California is in search of a Senior Vice President of Clinical Operations to spearhead the integration of essential clinical services across both inpatient and outpatient facilities. This includes oversight of...

  • Senior Financial Consultant

    2 weeks ago

    San Francisco, California, United States University of California Full time

    Position Title: Senior Financial Analyst - Cancer & Ambulatory ServicesDepartment: Finance - Business LineEmployment Type: Full TimeJob Overview:The Senior Financial Analyst plays a crucial role in applying extensive expertise in healthcare decision support and advanced professional concepts to complex projects. This position is essential for providing...

  • Senior Clinical Oversight Specialist

    2 weeks ago

    San Diego, California, United States Clinical Dynamix Full time

    The Senior Clinical Oversight Specialist plays a crucial role in the clinical research landscape, serving as the primary liaison for clinical research sites. This remote position involves conducting qualification and site initiation visits on behalf of the sponsor, as well as performing quality oversight assessments to evaluate the performance of the CRO...

  • Senior Clinical Oversight Specialist

    2 weeks ago

    San Diego, California, United States Clinical Dynamix Full time

    The Senior Clinical Oversight Specialist is a remote, field-based position responsible for offering support to clinical research sites as the primary liaison for the study. This role involves conducting qualification and site initiation visits on behalf of the sponsor, as well as performing quality oversight assessments to evaluate the performance of the CRO...

  • Senior Clinical Oversight Specialist

    2 weeks ago

    San Diego, California, United States Clinical Dynamix Full time

    The Senior Clinical Oversight Specialist plays a pivotal role in the remote field, acting as the primary liaison for clinical research sites throughout the study lifecycle. This position involves conducting essential qualification and site initiation visits on behalf of the sponsor, as well as performing quality oversight assessments to evaluate the...

  • Clinical Operations Senior Manager

    2 weeks ago

    San Diego, California, United States Proven Recruiting Full time

    Clinical Operations Senior ManagerProven Recruiting is currently seeking an experienced Clinical Operations Senior Manager to play a pivotal role in advancing oncology research initiatives. This position is essential for supporting the Head of Clinical Operations in the formulation and execution of innovative oncology therapies.Key Responsibilities:Oversee...

  • Clinical Operations Senior Manager

    2 weeks ago

    South San Francisco, California, United States Aligos Therapeutics Full time

    Job OverviewAbout Aligos Therapeutics:At Aligos, we are dedicated to transforming the lives of patients globally. As a prominent clinical-stage biopharmaceutical organization, our mission is to address critical healthcare needs.Founded in 2018 and publicly traded since 2020, we foster a science-driven culture that encompasses a wide range of expertise. Our...

  • Senior Vice President of Clinical Operations

    2 weeks ago

    San Francisco, California, United States UCSF Health Full time

    Position OverviewThe Office of the President - Adult Services is seeking a Senior Vice President of Clinical Operations to spearhead the management of shared clinical services across various inpatient and outpatient facilities. This role encompasses oversight of essential services including Laboratory, Pathology, Imaging, and Rehabilitation Services.Key...

  • Pharmacovigilance Operations Senior Manager

    2 weeks ago

    San Francisco, California, United States Biogen Full time

    Position Overview:Biogen is on the lookout for a Senior Manager in Pharmacovigilance Operations. This pivotal role within the Safety team entails overseeing and enhancing the pharmacovigilance processes associated with clinical development.Key Responsibilities:1. Manage the pharmacovigilance operations to ensure compliance with regulatory requirements.2....

  • Senior Clinical Imaging Specialist

    1 week ago

    San Francisco, California, United States University of California Full time

    Position Title: Senior Clinical Imaging SpecialistDepartment: Clinical EngineeringEmployment Type: Full TimeJob Code: 77033BROverview:Under the supervision of the Medical Imaging shop supervisor, the incumbent serves as a technical authority executing a range of routine and intricate technical responsibilities related to the installation, regular...

  • Senior Clinical Imaging Specialist

    1 week ago

    San Francisco, California, United States University of California Full time

    Position Title: Senior Clinical Imaging SpecialistDepartment: Clinical EngineeringEmployment Type: Full TimeJob Code: 77033BRPosition Overview:Under the supervision of the Medical Imaging shop supervisor, the individual serves as a technical authority executing a range of routine and intricate technical responsibilities related to the installation, scheduled...

  • Senior Clinical Operations Associate

    1 week ago

    South San Francisco, California, United States Meet Full time

    Position OverviewThe Senior Clinical Operations Associate will play a pivotal role in supporting the management and execution of clinical trials. Reporting directly to the Head of Clinical Operations, this position is essential for ensuring the effective oversight of contract research organizations (CROs) and key study collaborators, maintaining high...

  • Senior Manager Clinical Operations

    7 hours ago

    San Diego, California, United States Autobahn Therapeutics, Inc. Full time

    About Autobahn Therapeutics, Inc.Autobahn Therapeutics, Inc. is a biotechnology company focused on developing innovative treatments for CNS disorders. Our mission is to improve the lives of people affected by these conditions.Job SummaryWe are seeking a highly experienced Senior Manager Clinical Operations to join our team. This individual will be...

  • Senior Clinical Research Associate

    3 days ago

    South San Francisco, California, United States Structure Therapeutics Full time

    Job SummaryStructure Therapeutics is seeking a highly skilled and experienced Senior Clinical Research Associate to join our Clinical Operations team. As a key member of our team, you will be responsible for managing all clinical aspects of small to medium-sized clinical studies, ensuring compliance with protocol and overall clinical trial objectives.Key...

  • Operational Security Manager

    5 days ago

    San Francisco, California, United States Senior Care Authority of Inland Empire, CA Full time

    About the RoleWe are seeking a highly skilled and experienced Senior Security Response Engineering Manager to join our team at Senior Care Authority of Inland Empire, CA. As a key member of our security team, you will play a critical role in scaling and managing our operational security functions.Key ResponsibilitiesSecurity Automation Leadership:...

  • Facilities Operations Manager

    5 days ago

    San Francisco, California, United States Coterie Senior Living Full time

    Job SummaryCoterie Senior Living is seeking a highly skilled and experienced Facilities Operations Manager to oversee the maintenance and upkeep of our luxury senior living community. As a key member of our team, you will be responsible for ensuring the smooth operation of our facilities, managing maintenance teams, and providing exceptional customer service...

  • Senior Facilities Manager

    1 week ago

    San Francisco, California, United States Coterie Senior Living Full time

    The Director of Engineering Operations (Internal Title: Facilities Manager) plays a crucial role in overseeing the launch and continuous management of a premier senior living establishment situated in an urban high-rise setting. This position is responsible for all facets of maintenance operations, including leading the facilities team, ensuring the upkeep...

  • Senior Manager of Clinical Studies

    2 weeks ago

    South San Francisco, California, United States Alumis Full time

    Position OverviewSalary: Alumis Inc. is a pioneering company in precision medicine, dedicated to enhancing the lives of individuals affected by autoimmune disorders. Despite advancements in treatment over the past twenty years, numerous patients with immunologic conditions still face significant challenges. Our mission is to revolutionize outcomes for these...

  • Manager of Clinical Operations

    1 month ago

    San Francisco, California, United States On Target Executive Search Full time

    Manager of Clinical Operations Fairland, CA About Our ClientOur Client s Mission is to successfully restore our patient s quality of life through superior clinical care while creating an environment that inspires our team to develop and achieve their professional aspirations. Our Vision is to BE the BEST rehab provider in the communities we serve. Job...