Current jobs related to Senior Clinical Operations Manager - Cambridge, Massachusetts - Flagship Pioneering, Inc.

  • Senior Director of Clinical Operations

    4 weeks ago

    Cambridge, Massachusetts, United States Akebia Therapeutics Full time

    Job DescriptionJob Title: Senior Director, Clinical OperationsCompany: Akebia TherapeuticsJob SummaryAkebia Therapeutics is seeking a highly experienced Senior Director, Clinical Operations to lead our clinical development programs. The successful candidate will have a strong background in clinical trial management, with a proven track record of delivering...

  • Senior Clinical Trials Manager

    4 weeks ago

    Cambridge, Massachusetts, United States Merus Full time

    Senior Clinical Trials ManagerMerus is seeking a highly skilled Senior Clinical Trials Manager to join our Clinical Operations team. As a key member of our team, you will be responsible for ensuring the successful execution of clinical trials, from planning to close-out. Your expertise in clinical trial management, combined with your passion for oncology,...

  • Senior Manager, Clinical Researcher

    1 month ago

    Cambridge, Massachusetts, United States Moderna Therapeutics Full time

    Key ResponsibilitiesThe Senior Manager, Clinical Researcher will support the development of early and late phase Oncology Vaccine programs. This role will collaborate with the Study Physician to oversee clinical studies, review and interpret clinical trial data, and execute deliverables in collaboration with internal and external partners.The Clinical...

  • Senior Clinical Document Manager

    4 weeks ago

    Cambridge, Massachusetts, United States Beacon Hill Life Sciences - Boston Full time

    About the RoleWe are seeking a highly skilled Senior Clinical Document Manager to join our team at Beacon Hill Life Sciences in Boston. This is a unique opportunity to work with a dynamic organization that values diversity and is committed to excellence in clinical document management.Job SummaryThe Senior Clinical Document Manager will be responsible for...

  • Senior Finance and Operations Manager

    4 weeks ago

    Cambridge, Massachusetts, United States Massachusetts Institute of Technology Full time

    Job Title: Senior Finance and Operations ManagerJob Summary:We are seeking a highly skilled Senior Finance and Operations Manager to join our team at the Abdul Latif Jameel Poverty Action Lab (J-PAL). The successful candidate will be responsible for supporting J-PAL's mission to efficiently translate research into actionable poverty alleviation policies...

  • Senior Manager, Facilities Operations

    4 weeks ago

    Cambridge, Massachusetts, United States Editas Medicine Full time

    Transformative Opportunities in Gene EditingAt Editas Medicine, we are pioneering the possible. Our mission and commitment is to translate the power and potential of the CRISPR/Cas12a and CRISPR/Cas9 genome editing systems into a robust pipeline of medicines for people living with serious diseases around the world. Our goal is to discover, develop,...

  • Senior Marketing Operations Manager

    4 weeks ago

    Cambridge, Massachusetts, United States Wistia Full time

    Job Title: Senior Marketing Operations ManagerAbout the Role:Wistia is seeking a Senior Marketing Operations Manager to partner with the demand generation, lifecycle marketing, campaign teams, and other Marketing functions. The ideal candidate will thrive when applying their analytical and growth mindset, coupled with an aptitude for team collaboration and...

  • Senior Financial Operations Manager

    4 weeks ago

    Cambridge, Massachusetts, United States Draper Labs Full time

    Job Summary:The Senior Financial Operations Manager will serve as a senior member of the financial leadership team at Draper, reporting to the Vice President, CFO & Treasurer. This role oversees all accounting and financial operations activities and maintains a strong financial and internal control environment.This is a highly visible position that plays a...

  • Clinical Operations Excellence Manager

    4 weeks ago

    Cambridge, Massachusetts, United States Lifelancer Full time

    Job DescriptionAt Lifelancer, we're seeking a highly skilled Clinical Operations Excellence Manager to join our team. As a key member of our organization, you will play a crucial role in facilitating optimal clinical development operations, GCP compliance, and trial oversight.Key Responsibilities:Provide subject matter expertise to support Development...

  • Licensed Clinical Social Worker LCSW

    1 month ago

    Cambridge, Massachusetts, United States Senior Care Therapy Full time

    Job Title: Licensed Clinical Social Worker LCSWSenior Care Therapy is seeking a Licensed Clinical Social Worker LCSW to join our team of dedicated professionals. As a Licensed Clinical Social Worker LCSW, you will be responsible for providing high-quality psychotherapy services to our geriatric population in over 300 sub-acute, long-term care, and assisted...

  • Senior Manager, Clinical Compliance Expert

    4 weeks ago

    Cambridge, Massachusetts, United States BioSpace, Inc. Full time

    Clinical Compliance Leadership PositionThe Senior Manager, Clinical Compliance will provide critical support and guidance to clinical trial teams on Clinical Compliance requirements and activities.This role requires a collaborative partnership with cross-functional team members across the organization to ensure all trials are conducted in compliance with...

  • Senior Manager, Clinical Compliance

    4 weeks ago

    Cambridge, Massachusetts, United States BioSpace, Inc. Full time

    Job DetailsThe Role: The Senior Manager, Clinical Compliance will provide support and guidance to clinical trial teams on Clinical Compliance requirements and activities. The candidate will work to support trial teams across different stages of development and multiple therapeutic areas. The successful candidate will be skilled at both understanding and...

  • Clinical Operations Director

    4 weeks ago

    Cambridge, Massachusetts, United States QurAlis Full time

    About QurAlisWe are a clinical-stage biotechnology company advancing a pipeline with therapeutic candidates that target specific components of ALS and FTD pathology and defined patient populations based on both disease-causing genetic mutation(s) and clinical biomarkers.Job SummaryWe are seeking a motivated experienced Vice President of Clinical Operations...

  • Clinical Data Manager I

    4 weeks ago

    Cambridge, Massachusetts, United States Prometrika LLC Full time

    Job OverviewPrometrika LLC is seeking a highly skilled Clinical Data Manager I to join our team. As a key member of our clinical operations department, you will be responsible for managing data for assigned studies, ensuring data integrity and quality.Key Responsibilities:Develop and maintain study-specific documentation, including Data Management Plans,...

  • Clinical Operations Supervisor

    1 month ago

    Cambridge, Massachusetts, United States Mass General Brigham Full time

    Job DescriptionMass General Brigham is seeking a Registered Nurse (RN) Clinic Supervisor for a nursing job in Cambridge, Massachusetts.Specialty: ClinicDiscipline: RNDuration: Ongoing24 hours per weekShift: 8 hoursEmployment Type: StaffAs a Clinical Operations Supervisor, you will be responsible for the 360 clinical, logistic, and administrative oversight of...

  • Clinical Operations Lead

    4 weeks ago

    Cambridge, Massachusetts, United States Garuda Therapeutics Full time

    We are seeking a highly skilled Clinical Operations Lead to join our team at Garuda Therapeutics. This critical role will be responsible for leading the planning, implementation, and execution of global clinical trials.The ideal candidate will have strong collaboration, vendor management, and project management skills, with a proven track record of success...

  • Senior Clinical Development Solutions Architect

    4 weeks ago

    Cambridge, Massachusetts, United States BlueRock Therapeutics Full time

    At BlueRock Therapeutics, we are seeking a highly skilled Senior Clinical Development Solutions Architect to join our team. This individual will be responsible for owning the product portfolio and related relationships with key stakeholders across the Clinical Development functions.The successful candidate will integrate, develop, and deliver innovative and...

  • Senior Solutions Architect, Clinical Development Solutions

    4 weeks ago

    Cambridge, Massachusetts, United States BlueRock Therapeutics Full time

    At BlueRock Therapeutics, we are seeking a highly skilled Senior Solutions Architect to join our Clinical Development team. As a key member of our IT organization, you will be responsible for designing and implementing innovative technology solutions to support our rapidly expanding Clinical Development organization.Key Responsibilities:Own the product...

  • Senior Director of Clinical Research

    4 weeks ago

    Cambridge, Massachusetts, United States Pfizer Full time

    Job SummaryThe Senior Director of Clinical Research will lead the development of first-in-man, proof-of-mechanism, and proof-of-concept studies for novel biological and small molecule therapies in respiratory disease programs.Key ResponsibilitiesDevelop disease-specific global networks of investigators and key opinion leaders for trial design, management,...

  • Senior Data Management Specialist

    4 weeks ago

    Cambridge, Massachusetts, United States Novartis International AG Full time

    Job OverviewThe Biomarker Development group at Novartis Bio Medical Research seeks a Senior Scientist, Imaging Data Management in our Clinical Imaging & Analytics team.This role aims to execute our clinical imaging data strategy to prospectively build raw data.Key ResponsibilitiesExecute clinical imaging data strategyBuild raw dataProspectively manage...

Senior Clinical Operations Manager

1 month ago

Cambridge, Massachusetts, United States Flagship Pioneering, Inc. Full time
About Alltrna

Alltrna is a pioneering company that is transforming the field of tRNA biology and therapeutics. As a leader in this space, we are committed to deciphering the complexities of tRNA and developing innovative treatments for thousands of diseases. Our platform incorporates AI/ML tools to learn the tRNA language and deliver programmable molecules with broad therapeutic potential.

The Role:

We are seeking a highly experienced and skilled Head of Clinical Operations to join our team. The successful candidate will be responsible for planning and executing early-stage clinical trials, including First-in-human Phase 1 and Phase 2 studies. This will involve interfacing with internal and external stakeholders to ensure smooth execution of studies, including start-up, drug and budget forecasting, and acquisition of detailed, high-quality clinical and translational data to support evaluation of the therapeutics under study.

The ideal candidate will have a minimum of 10 years of experience in clinical operations across at least 2 therapeutics areas, including rare diseases and oncology. They will also have experience managing Phase 1 dose-finding trials, leading patient-finding initiatives, and managing CROs and vendors. Additionally, they will have a strong understanding of the drug development process from IND to NDA/BLA and be able to communicate effectively and efficiently with cross-functional team members.

Key Responsibilities:
  • Develop clinical operations strategy for each agent in development
  • Cross-functional collaboration to develop needed outputs such as protocols, annual safety reports and investigator brochure, clinical study reports, presentations, regulatory submissions, and publications
  • Evaluate external collaborators including Contract Research Organizations (CROs) and sites and select the best candidates for each needed function
  • Develop and lead patient finding and recruitment strategy, planning, and forecasting
  • Develop and manage standard operating procedures (SOPs) for the organization and its external collaborators
  • Continuously evaluate performance of external collaborators and vendors, troubleshoot and recommend a path forward when challenges are encountered
  • Develop and manage study timelines, working with internal partners
What We Offer:
  • A dynamic early-stage work environment and highly interdisciplinary, talented, and collaborative team
  • Participation in an unprecedented opportunity to advance a single tRNA medicine to restore disrupted protein production, regardless of target, for thousands of diseases with the same underlying genetic mutation
  • Opportunity to build and develop a high-performing and impactful team within the next 2 years
  • Comprehensive, competitive healthcare and dental coverage through Blue Cross Blue Shield, vision coverage through VSP, family leave, flexible paid time off, 401k retirement plan, disability and life insurance, and fully covered parking/commuter benefits
  • Professional growth opportunities through mentoring, training, immersion in cross-functional projects, and opportunities to learn and try new things
Our Core Values:
  • PATIENTS DESERVE BETTER. We are transforming medicine, boldly building a new future for patients.
  • CURIOSITY SPARKS DISCOVERY. We ardently explore the unknown, catalyzing new scientific breakthroughs.
  • COURAGE PROPELS US FORWARD. We take thoughtful risks without fear of failure, growing with each experience.
  • OUR PURPOSE FUELS US. We each lead and work with focus and passion to design groundbreaking tRNA medicines.
  • WE ARE ONE TEAM. We are united on trust and collaboration, embracing all voices and experiences.
We Give It Our All, Every Day, For Patients Everywhere. We Are Alltrna.