Associate Director, Biomarker Statistics
2 weeks ago
The Role:
This role is an exciting opportunity to be a critical part of the clinical development group of a high growth organization that is radically changing the biotech industry. The Associate Director of Clinical Biomarkers will 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 in clinical stage ID programs. This position reports to Modernas Senior director of Clinical Biomarkers. The role will work collaboratively across clinical teams to ensure strategy, planning, execution and data delivery of biomarker lab data for early and late phase infectious disease vaccine clinical trials conducted by Moderna.
Heres What Youll Do:
Serve as the biostatistics leader and point-of-contact in multiple clinical development teams responsible for determining Clinical Biomarker study strategies and delivering results with high quality and on time.
Partner with a team of dedicated and senior Clinical Biomarker scientists on the science and bioanalytical assays for Modernas early and late phase infectious disease vaccine programs. Oversee biomarker plans and strategy with input from research and clinical leads for ID studies. Responsible to ensure assay labs complete appropriate development, qualification or validation of biomarker assays in order to execute the clinical biomarker plan on time and with good quality for ID clinical programs.
Bring innovative statistical thinking and methodologies to help drive applications of suit-for-purpose statistical methods that enhance the probability of successes for clinical development programs.
Collaborate with internal and external stakeholders to ensure effective quantitative approaches are applied to the collection and analysis of a wide variety of data types. Serve as a primary point of contact for biomarker operations across ID teams, and with external collaborators, assay labs and CROs. Ensure timely and efficient delivery of all biomarkers operational aspects across multiple ID clinical trials
Develop statistical sections of clinical development plans, protocols, statistical analysis plans, and key specifications for statistical programming implementation of analyses
Plan, manage, and track biomarker related biostatistical activities, timelines, and resources and assure operational excellence
Support interactions with regulatory agencies and effectively address the statistical questions and requests regarding Biomarker endpoints
Review and/or author SOPs and/or work Instructions related to biostatistics practices. Develop and provide operational input and recommendations into all study related documentation (including protocol, lab manual, informed consent form, IB and regulatory filings) and processes, and ensure collection, delivery and analysis of biosamples in compliance with these documents as well as GCP/ICH
Collaborate with and manage internal and external functions (e.g. CROs, software vendors, clinical development partners, etc.) to ensure meeting project timelines and goals
Heres What Youll Bring to the Table:
PhD (with at least 7 years pharmaceutical/biotechnology experience) in a related science with a focus on infectious disease.
Solid experience in the application of biomarkers during development of assets required including experience with clinical translational research, development, validation and implementation of biomarkers in the ID space.
Outstanding communication skills (verbal and written).
Strong working knowledge of relevant FDA, EU, ICH guidelines and regulations.
Ability to manage multiple projects in a fast-paced environment.
Experience working with CROs, vendors, and relationship management Strong communication and project management skills
Deep understanding of the regulatory expectations for pivotal biomarkers in clinical trials
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 modernatx.com/careers 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 leavesandaccommodations@modernatx.com. (EEO/AAP Employer)
-
-
Cambridge, United States Moderna, Inc. Full timeThe Role:Moderna is seeking an Associate Director in the Biomarker Operations group within the Clinical Biomarkers Department to provide leadership and strategy to impact biomarker operations deliverables in collaboration with biomarker leads, clinical teams, and partner CROs. This position will lead collaboratively across all therapeutic area clinical teams...
-
Cambridge, United States Moderna, Inc. Full timeThe 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 Moderna, Inc. Full timeThe 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,...
-
Associate Director, Clinical Biomarkers Therapeutics
2 months ago
Cambridge, United States Moderna, Inc. Full timeThe Role:Moderna is seeking a Clinical Biomarker Lead to develop and drive biomarker plans across clinical-stage rare disease programs. This position reports to Modernas Director of Clinical Biomarkers for Therapeutics. The Associate Director will work collaboratively across multiple clinical teams (internal or external CROs) to ensure planning, execution,...
-
Director, Clinical Biomarkers
3 months ago
Cambridge, Massachusetts, United States Moderna, Inc. Full timeThe 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...
-
Director, Clinical Biomarkers
3 months ago
Cambridge, United States Moderna, Inc. Full timeThe 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...
-
Oncology Clinical Biomarkers Specialist
2 weeks ago
Cambridge, Massachusetts, United States Randstad USA Full timePosition: 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 BlueRock Therapeutics Full timeAbout 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...
-
Senior Manager, Oncology Clinical Biomarkers
2 weeks ago
Cambridge, Massachusetts, United States Moderna Therapeutics Full timePosition 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 BlueRock Therapeutics Full timeDirector 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 BlueRock Therapeutics Full timeDirector 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...
-
Cambridge, Massachusetts, United States BlueRock Therapeutics Full timeDirector of Imaging and Biomarkers in 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, thereby crafting a new era of cellular medicines aimed at extensive patient...
-
Sr. Manager, Clinical Biomarkers, Oncology
2 months ago
Cambridge, United States Moderna, Inc. Full timeThe Role:Moderna is seeking a Sr. Manager, Clinical Biomarkers to develop and drive biomarker plans across clinical stage Oncology programs. This position reports to Modernas 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 BlueRock Therapeutics Full timeAbout 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...
-
Sr. Manager, Clinical Biomarkers, Oncology
2 months ago
Cambridge, Massachusetts, United States ModernaTX, Inc. Full timeThe 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 Therapeutics Full timeAbout the RoleWe are seeking a highly experienced Regulatory Affairs Director to lead our medical devices, molecular testing, and biomarkers regulatory strategy and oversight. As a key member of our team, you will be responsible for ensuring that our products meet the highest regulatory standards and are compliant with global regulations.Key...
-
Sr. Manager, Clinical Biomarkers Therapeutics
2 months ago
Cambridge, United States Moderna, Inc. Full timeThe Role:Moderna is seeking a Clinical Biomarker scientist to develop, drive, and execute biomarker plans across clinical-stage therapeutic programs. This position reports to Modernas Director of Clinical Biomarkers for Therapeutics. The Sr. Manager/Manager will work collaboratively across multiple clinical teams (internal and/or external CROs) to ensure the...
-
Advisor - Statistics (Pre-Clinical Statistician)
4 weeks ago
Cambridge, Massachusetts, United States Eli Lilly and Company Full timeAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...
-
Advisor - Statistics (Pre-Clinical Statistician)
4 weeks ago
Cambridge, Massachusetts, United States Lilly Full timeAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...
-
Advisor - Statistics (Pre-Clinical Statistician)
4 weeks ago
Cambridge, United States Eli Lilly and Company Full timeAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...
