Sr. Specialist, Global PBMC Operations, Clinical Biomarkers

2 months ago


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

The Role

In this role, you will be entrusted with the development, management, coordination, and enhancement of clinical site and laboratory PBMC processing initiatives as part of the Moderna Clinical Biomarker Operations Team. This role emphasizes the importance of consistency and methodical execution in its duties. The specialist will utilize data-driven insights and evaluations of Moderna practices to advance the program and elevate the quality of PBMC specimens produced. Success in this role hinges on a blend of autonomous work and collaborative efforts. As an expert in the field, the specialist will balance providing guidance, support, and educational training to the team.

Heres What Youll Do Collaborate with the PBMC leadership to determine and prioritize the responsibilities in relation to Modernas mission and PBMC management. Design, implement, and continuously improve general and study-specific training, as well as cross-functional training for stakeholders on standardization and updates in PBMC management. Develop training programs focused on PBMC management quality assurance/control. Evaluate site and lab preparedness to receive training and address inquiries regarding equipment, supplies, and reagents. Support site and lab PBMC qualifications by providing PBMC processing training, ensuring site qualification sample submissions, ensuring timely evaluation of specimens and communication of results, and ensuring remedial training as appropriate. Support continued site and lab PBMC quality monitoring by tracking site submissions, providing follow-through with overdue sites with pending/overdue submissions, assuring timely evaluations. Assisting in the development of additional regional PBMC oversite strategies Perform quality review of study data as related to PBMC quality indicators, including documentation and data entry omissions or errors. Provide appropriate remediation, communication with stakeholders, and escalate as appropriate. Offer support and assessments for sites and labs through data review, virtual and in-person visits. Support study development as a PBMC subject matter expert. Manage and address queries regarding PBMC management and quality; update the formal FAQ as needed. Create and provide communication for site and laboratory related to key performance indicators for PBMC management. Deliver regular updates during stakeholder calls. Conduct remedial or focused on-site training sessions for sites and labs as required. Create, support, and maintain job-specific digital specimen management tools. Heres What Youll Need (Basic Qualifications) Bachelor's degree in a biological science discipline. At least 5 years of experience in a specimen processing laboratory or a related field. Proficiency in Good Clinical Laboratory Practices (GCLP), Good Clinical Practices (GCP), or equivalent. Proven project management experience or related expertise. Ability to work independently with minimal oversight. Flexibility and willingness to travel 20+% Heres What Youll Bring to the Table (Preferred Qualifications) Specific experience with PBMC processing, storage, and clinical trials. Exceptional training and public speaking abilities. Proficient with computer applications such as Microsoft Office Suite, Smartsheet, etc. Effective interpersonal communication and time management capabilities. A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.Moderna provides employees with a comprehensive and innovative suite of benefits, including: Highly competitive and inclusive medical, dental and vision coverage options Flexible Spending Accounts for medical expenses and dependent care expenses Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities Family care benefits, including subsidized back-up care options and on-demand tutoring Free premium access to fitness, nutrition, and mindfulness classes Exclusive preferred pricing on Peloton fitness equipment Adoption and family-planning benefits Dedicated care coordination support for our LGBTQ+ community Generous paid time off, including:
Vacation, sick time and holidays
Volunteer time to participate within your community
Discretionary year-end shutdown
Paid sabbatical after 5 years; every 3 years thereafter Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents 401k match and Financial Planning tools Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options Complimentary concierge service including home services research, travel booking, and entertainment requests Free parking or subsidized commuter passes Location-specific perks and extras NoticesModerna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please applyModerna is a smoke-free, alcohol-free, and drug-free work environmentModerna is proud to be an equal opportunity workplace and is an affirmative action employer. Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. Were focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best. Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Talent Acquisition Partner or contact the Accommodations team at (EEO/AAP Employer).

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:Highly competitive and inclusive medical, dental and vision coverage optionsFlexible Spending Accounts for medical expenses and dependent care expensesLifestyle Spending Account funds to help you engage in personal enrichment and self-care activitiesFamily care benefits, including subsidized back-up care options and on-demand tutoringFree premium access to fitness, nutrition, and mindfulness classesExclusive preferred pricing on Peloton fitness equipmentAdoption and family-planning benefitsDedicated care coordination support for our LGBTQ+ communityGenerous paid time off, including:
Vacation, sick time and holidays
Volunteer time to participate within your community
Discretionary year-end shutdown
Paid sabbatical after 5 years; every 3 years thereafterGenerous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents 401k match and Financial Planning toolsModerna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit optionsComplimentary concierge service including home services research, travel booking, and entertainment requestsFree parking or subsidized commuter passesLocation-specific perks and extras About Moderna Since our founding in 2010, we have aspired to build the leading mRNA technology platform, theinfrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our peopleare the driving force behind our scientific progress and our culture.Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.

We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.

If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit to learn more about our current opportunities.

Moderna is a smoke-free, alcohol-free and drug-free work environment.

Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply

Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. Were focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.

Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at (EEO/AAP Employer)

-



  • Cambridge, Massachusetts, United States Moderna, Inc. Full time

    The Role:Moderna is currently seeking an experienced and highly motivated Clinical Consent Sr. Specialistwho is eager to develop their career in a fast-paced company.The successful candidate will be responsible for editing and writing informed consent language for clinical biomarker research and biobanking across Modernas clinical protocols in accordance...


  • Cambridge, Massachusetts, United States ModernaTX, Inc. Full time

    The Role:Moderna is seeking a Sr. Manager, Clinical Biomarkers to develop and drive biomarker plans across clinical stage Oncology programs. This position reports to Moderna's Associate Director of Oncology, Clinical Biomarkers. The Senior Manager will work collaboratively across biomarker and translational teams (internal, external CROs) to ensure planning,...


  • Cambridge, Massachusetts, United States Moderna, Inc. Full time

    The Role:Moderna is seeking a Director of Clinical Biomarkers to serve as a scientific leader and point of contact for clinical teams in the Infectious Disease (ID) space with responsibilities for developing and driving pivotal biomarker plans across clinical stage ID programs. This position reports to Modernas Sr. Director of Infectious Disease, Clinical...


  • Cambridge, Massachusetts, United States Randstad USA Full time

    Position: Contractor, Clinical Biomarkers – OncologyCompensation: $60-70 per hourContract Type: Potential for Permanent HireRandstad USA is in search of a Contractor specializing in Clinical Biomarkers to spearhead and implement biomarker strategies within our oncology clinical programs. This role will report to the Associate Director of Oncology, Clinical...


  • Cambridge, Massachusetts, United States Randstad Life Sciences US Full time

    Position Overview: We are seeking a skilled Contractor for Clinical Biomarker Development to enhance and manage biomarker strategies within clinical stage Oncology programs.Key Responsibilities:Utilize extensive knowledge and technical proficiency in various biomarker assays, particularly in the immuno-oncology sector, including NGS, scRNAseq, TCR...


  • Cambridge, Massachusetts, United States Randstad USA Full time

    Position Overview:Randstad USA is seeking a Senior Manager of Clinical Biomarkers to spearhead the development and execution of biomarker strategies across clinical oncology initiatives. This role is pivotal in collaborating with both internal teams and external partners to ensure the successful delivery of biomarker data for clinical trials.Key...


  • Cambridge, Massachusetts, United States Randstad Life Sciences US Full time

    Position: Clinical Biomarker Contractor - OncologyLocation: Flexible (2-3 days/week)Contract Duration: 6 Month Contract with potential for Full-Time Employment based on performanceWe are looking for a Clinical Biomarker Contractor specializing in Oncology.Essential Qualifications:Master's or Doctorate in a relevant scientific discipline (e.g., Immunology,...


  • Cambridge, Massachusetts, United States Randstad Life Sciences US Full time

    SENIOR CLINICAL BIOMARKER MANAGER - ONCOLOGYHybrid Position: Onsite 2 Days Per WeekContract Duration: 4 Months with Possibility of ExtensionRole Overview:We are seeking a Senior Clinical Biomarker Manager to spearhead the development and execution of biomarker strategies across clinical-stage oncology initiatives. This role involves close collaboration with...


  • Cambridge, Massachusetts, United States Randstad Life Sciences US Full time

    SENIOR CLINICAL BIOMARKER MANAGER - ONCOLOGYHybrid Position: Onsite 2 Days WeeklyContract Duration: 4 Months with Possibility of ExtensionRole Overview:We are looking for a Senior Clinical Biomarker Manager to spearhead the development and execution of biomarker strategies across various clinical stage oncology initiatives. This role requires collaboration...


  • Cambridge, Massachusetts, United States Moderna Therapeutics Full time

    About the RoleModerna Therapeutics is seeking a highly skilled and experienced Senior Manager, Clinical Biomarkers and Oncology to join our team. This is a critical role that will be responsible for developing and driving biomarker plans across clinical stage Oncology programs.Key ResponsibilitiesDevelop and implement biomarker plans for clinical stage...


  • Cambridge, Massachusetts, United States Moderna Therapeutics Full time

    Position Overview:Moderna Therapeutics is on the lookout for a Senior Manager specializing in Clinical Biomarkers to spearhead and implement biomarker strategies across our clinical Oncology initiatives. This role will report directly to the Associate Director of Oncology, Clinical Biomarkers.The Senior Manager will collaborate closely with both internal...


  • Cambridge, Massachusetts, United States Moderna, Inc. Full time

    The Role:Moderna is seeking a Clinical Biomarker leader to drive biomarker assay plans across clinical stage oncology programs. This position reports to Modernas Director of Clinical Biomarkers. The Associate Director will work collaboratively across several clinical teams(internal, external CROs) to ensure biomarker assay development strategy, planning,...


  • Cambridge, Massachusetts, United States BlueRock Therapeutics Full time

    About the RoleWe are seeking a highly skilled Director of Imaging and Biomarkers to join our Translational Medicine team at BlueRock Therapeutics. As a critical member of our team, you will leverage your expertise in CNS, ophthalmic, and inflammation imaging to advance our development pipeline.Key ResponsibilitiesDevelop Translational Strategies: Design and...


  • Cambridge, Massachusetts, United States BlueRock Therapeutics Full time

    Director of Imaging and Biomarkers, Translational MedicineBlueRock Therapeutics, a premier engineered cell therapy organization under Bayer AG, is at the forefront of utilizing its innovative cell+gene platform to facilitate cellular differentiation and genetically modify cells, aiming to pioneer a new era of cellular therapies that cater to extensive...


  • Cambridge, Massachusetts, United States QurAlis Full time

    ABOUT QURALISQurAlis is at the forefront of neurodegenerative research, dedicated to pioneering innovative solutions for conditions such as amyotrophic lateral sclerosis (ALS) and frontotemporal dementia (FTD). Our team, composed of esteemed neurobiologists from prestigious institutions, is committed to advancing precision medicine through rigorous...


  • Cambridge, Massachusetts, United States Novartis Farmacutica Full time

    Job SummaryWe are seeking a highly skilled Senior Research Scientist to join our Clinical Genetics and Genomics team at Novartis Farmacutica. As a key member of our team, you will be responsible for developing and implementing innovative genetic and genomic biomarker assays, including targeted and NGS-based technologies.Key ResponsibilitiesDevelop, validate,...


  • Cambridge, Massachusetts, United States BlueRock Therapeutics Full time

    About the RoleWe are seeking a highly skilled Director of Imaging and Biomarkers, Translational Medicine to join our team at BlueRock Therapeutics. As a critical member of our Translational Medicine team, you will leverage your expertise in CNS, ophthalmic, and inflammation imaging to advance our development pipeline.Key ResponsibilitiesDevelop Translational...


  • Cambridge, Massachusetts, United States QurAlis Full time

    ABOUT QURALISQurAlis is at the forefront of neurobiology, dedicated to pioneering innovative solutions for neurodegenerative diseases. Our mission is to develop precise therapeutic interventions that significantly impact conditions such as amyotrophic lateral sclerosis (ALS) and frontotemporal dementia (FTD). With a foundation built by esteemed...


  • Cambridge, Massachusetts, United States QurAlis Full time

    ABOUT QURALISQurAlis is at the forefront of neurobiology, striving to revolutionize the treatment landscape for neurodegenerative diseases such as amyotrophic lateral sclerosis (ALS) and frontotemporal dementia (FTD). Our foundation is built on a team of esteemed neurobiologists from Harvard Medical School and Harvard University, dedicated to the discovery...


  • Cambridge, Massachusetts, United States BlueRock Therapeutics Full time

    Director of Imaging and Biomarkers, Translational MedicineBlueRock Therapeutics, a pioneering entity under Bayer AG, stands at the forefront of engineered cell therapy, utilizing a distinctive cell+gene platform to guide cellular differentiation and genetically modify cells, paving the way for a new era of cellular medicines aimed at addressing widespread...