Position Overview The Associate Director, Digital Biomarker Lead will serve as the internal strategic and digital scientist SME for digital biomarker development, owning the pathway from concept of ...
Position Overview The Associate Director, Digital Biomarker Lead will serve as the internal strategic and digital scientist SME for digital biomarker development, owning the pathway from concept of ...
As a Clinical Trials Manager, Biomarker/Bioanalytical Operations, You will work with and collaborate with Clinical Operations, Biomarker Sciences, Clinical Pharmacology and other cross-functional ...
As a Clinical Trials Manager, Biomarker/Bioanalytical Operations, You will work with and collaborate with Clinical Operations, Biomarker Sciences, Clinical Pharmacology and other cross-functional ...
As a Clinical Trials Manager, Biomarker/Bioanalytical Operations, You will work with and collaborate with Clinical Operations, Biomarker Sciences, Clinical Pharmacology and other cross-functional ...
As a Clinical Trials Manager, Biomarker/Bioanalytical Operations, You will work with and collaborate with Clinical Operations, Biomarker Sciences, Clinical Pharmacology and other cross-functional ...
As a Clinical Trials Manager, Biomarker/Bioanalytical Operations, You will work with and collaborate with Clinical Operations, Biomarker Sciences, Clinical Pharmacology and other cross-functional ...
As a Clinical Trials Manager, Biomarker/Bioanalytical Operations, You will work with and collaborate with Clinical Operations, Biomarker Sciences, Clinical Pharmacology and other cross-functional ...
Manager, Biomarker Operations
Cambridge, MA ยท On-site
$109K - $174K/yr
The Role Moderna is seeking a Biomarker Operations Manager to support biomarker and clinical teams across its clinical trials as well as with external biorepositories, assay laboratories and CROs.
Manager, Biomarker Operations
Cambridge, MA ยท On-site
$109K - $174K/yr
The Role Moderna is seeking a Biomarker Operations Manager to support biomarker and clinical teams across its clinical trials as well as with external biorepositories, assay laboratories and CROs.
Senior Scientist - ELISA / LBA / Biomarker
$99K - $136K/yr
Apply knowledge of biomarkers, translational medicine, and assay validation principles to design robust assays suitable for clinical trial use and aligned with regulatory expectations, including FDA ...
Senior Scientist - ELISA / LBA / Biomarker
$99K - $136K/yr
Apply knowledge of biomarkers, translational medicine, and assay validation principles to design robust assays suitable for clinical trial use and aligned with regulatory expectations, including FDA ...
Senior Scientist - ELISA / LBA / Biomarker
Boston, MA ยท On-site
$99K - $135K/yr
Apply knowledge of biomarkers, translational medicine, and assay validation principles to design robust assays suitable for clinical trial use and aligned with regulatory expectations, including FDA ...
Senior Scientist - ELISA / LBA / Biomarker
Boston, MA ยท On-site
$99K - $135K/yr
Apply knowledge of biomarkers, translational medicine, and assay validation principles to design robust assays suitable for clinical trial use and aligned with regulatory expectations, including FDA ...
Align biomarker plans with program objectives, regulatory expectations, and intended clinical use. * Author, review, and/or approve bioanalytical reports and regulatory and clinical documents ...
Quick apply
Align biomarker plans with program objectives, regulatory expectations, and intended clinical use. * Author, review, and/or approve bioanalytical reports and regulatory and clinical documents ...
Align biomarker plans with program objectives, regulatory expectations, and intended clinical use. * Author, review, and/or approve bioanalytical reports and regulatory and clinical documents ...
Align biomarker plans with program objectives, regulatory expectations, and intended clinical use. * Author, review, and/or approve bioanalytical reports and regulatory and clinical documents ...
The role partners closely with Discovery, Bioinformatics, Biomarker, Clinical, and other development functions to ensure mechanistic hypotheses and patient-relevant data are fully integrated into ...
The role partners closely with Discovery, Bioinformatics, Biomarker, Clinical, and other development functions to ensure mechanistic hypotheses and patient-relevant data are fully integrated into ...
Principal Biostatistician (Biomarker Analyst -EMEA and US BASED) Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We ...
Principal Biostatistician (Biomarker Analyst -EMEA and US BASED) Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We ...
ELISA, MSD, ELISA, Luminex) for clinical biomarker analysis. * Design experimental plans and lead execution of sample analysis to generate high-quality and robust biomarker data. * Collaborate with ...
ELISA, MSD, ELISA, Luminex) for clinical biomarker analysis. * Design experimental plans and lead execution of sample analysis to generate high-quality and robust biomarker data. * Collaborate with ...
Sr Principal Scientist / Associate Director, Biomarker Assay Development Laboratory
Cambridge, MA ยท On-site
Yes Imagine advancing biomarker science that helps transform promising discoveries into life-changing medicines. As a Sr Principal Scientist / Associate Director, Biomarker Assay Development ...
Sr Principal Scientist / Associate Director, Biomarker Assay Development Laboratory
Cambridge, MA ยท On-site
Yes Imagine advancing biomarker science that helps transform promising discoveries into life-changing medicines. As a Sr Principal Scientist / Associate Director, Biomarker Assay Development ...
Principal Scientist, Clinical Biomarker, Immunology & Immuno-Oncology (Hematology)
Somerset, NJ ยท Hybrid
Legend Biotech is seeking a Principal Scientist, Clinical Biomarker, Immunology & Immuno-Oncology (Hematology) as part of the Early Drug Development team based in Somerset, NJ . Role Overview We are ...
Principal Scientist, Clinical Biomarker, Immunology & Immuno-Oncology (Hematology)
Somerset, NJ ยท Hybrid
Legend Biotech is seeking a Principal Scientist, Clinical Biomarker, Immunology & Immuno-Oncology (Hematology) as part of the Early Drug Development team based in Somerset, NJ . Role Overview We are ...
Perform studies to define pharmacodynamic biomarkers of response and disease progression, as a member of a discovery team and can investigate and articulate how these biomarkers may translate to the ...
Perform studies to define pharmacodynamic biomarkers of response and disease progression, as a member of a discovery team and can investigate and articulate how these biomarkers may translate to the ...
Director, Imaging Biomarkers
Waltham, MA ยท On-site
$272K/yr
This pivotal role will ensure that imaging biomarker strategies are scientifically rigorous, clinically relevant, and conducive to robust therapeutic development. The person in this role focuses on ...
Director, Imaging Biomarkers
Waltham, MA ยท On-site
$272K/yr
This pivotal role will ensure that imaging biomarker strategies are scientifically rigorous, clinically relevant, and conducive to robust therapeutic development. The person in this role focuses on ...
Perform studies to define pharmacodynamic biomarkers of response and disease progression, as a member of a discovery team and can investigate and articulate how these biomarkers may translate to the ...
Perform studies to define pharmacodynamic biomarkers of response and disease progression, as a member of a discovery team and can investigate and articulate how these biomarkers may translate to the ...
Director, Imaging Biomarkers
Waltham, MA ยท On-site
$196K - $240K/yr
This pivotal role will ensure that imaging biomarker strategies are scientifically rigorous, clinically relevant, and conducive to robust therapeutic development. The person in this role focuses on ...
Director, Imaging Biomarkers
Waltham, MA ยท On-site
$196K - $240K/yr
This pivotal role will ensure that imaging biomarker strategies are scientifically rigorous, clinically relevant, and conducive to robust therapeutic development. The person in this role focuses on ...
Director, Imaging Biomarkers
$196K - $240K/yr
This pivotal role will ensure that imaging biomarker strategies are scientifically rigorous, clinically relevant, and conducive to robust therapeutic development. The person in this role focuses on ...
Director, Imaging Biomarkers
$196K - $240K/yr
This pivotal role will ensure that imaging biomarker strategies are scientifically rigorous, clinically relevant, and conducive to robust therapeutic development. The person in this role focuses on ...
In this strategic role, you will guide biomarker strategies for obesity and cardiometabolic programs and directly contribute to clinical and regulatory decision-making. The position requires ...
In this strategic role, you will guide biomarker strategies for obesity and cardiometabolic programs and directly contribute to clinical and regulatory decision-making. The position requires ...
Biomarker information
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How much do biomarker jobs pay per year?
What is a biomarker?
A Biomarker job involves researching and identifying biological indicators (biomarkers) that help diagnose diseases, track disease progression, or monitor treatment responses. Professionals in this field work in pharmaceuticals, biotechnology, or healthcare, using advanced laboratory techniques and data analysis to validate biomarkers for clinical use. They collaborate with scientists, clinicians, and regulatory teams to ensure biomarkers meet medical and regulatory standards. This role is crucial in developing precision medicine, improving patient care, and advancing drug development.
What skills and qualifications are needed to thrive as a biomarker?
To thrive as a biomarker scientist, you need a strong background in molecular biology, biochemistry, or related biomedical sciences, often supported by an advanced degree (MS or PhD). Familiarity with laboratory techniques such as ELISA, PCR, mass spectrometry, and data analysis software like R or SAS is essential. Critical thinking, attention to detail, and effective communication help biomarker scientists excel in both independent and collaborative research settings. These skills ensure accurate identification and validation of biomarkers, which are crucial for advancing diagnostics, drug development, and patient care.
What typical challenges do biomarker scientists face in their daily work?
Biomarker scientists often encounter challenges related to variability in biological samples, stringent validation protocols, and the complex interpretation of large or multidimensional datasets. Overcoming these obstacles requires a meticulous approach to experimental design, robust data analysis, and effective troubleshooting skills. Teamwork is also essential, as biomarker scientists regularly collaborate with clinicians, bioinformaticians, and regulatory experts to ensure research breakthroughs translate into real-world patient benefits. Developing resilience and adaptability helps professionals stay effective despite shifting project requirements or unforeseen experimental hurdles.
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Full-time
Posted 4 days ago
Job description
Kardigan is a heart health company working to make cardiovascular disease preventable, curable and no longer the leading cause of death in the world.
It is Kardigan's mission to develop multiple targeted treatments in parallel that bring people with cardiovascular diseases to the cures they deserve.
Led by Tassos Gianakakos, Jay Edelberg, M.D., Ph.D., and Bob McDowell, Ph.D., Kardigan's co-founders have reunited after leading MyoKardia to discover and develop mavacamten, the first cardiac myosin inhibitor, resulting in an acquisition by Bristol Myers Squibb in 2020.
We have a cutting-edge discovery and translational research platform, a pipeline of late-stage candidates, and an industry-leading team that is driven to improve the lives of patients.
At Kardigan, we are motivated by our values which guide how we work, interact, and achieve our goals. Driven by patients and their families, we are deeply committed to improving the lives of patients and prioritizing their needs above all else. We believe in being authentic-leading with truth to bring out the best in others by creating an environment where every person knows they will be fully accepted. With an eagerness to learn, we encourage the highest levels of curiosity and are open to changing our minds. We are committed to winning as a team with urgency, excellence, and intention, and support each other no matter what role we play or where we sit. Lastly, we strive to enable the impossible because patients are counting on us. We are not afraid to take risks to unlock innovation and advance scientific discoveries.
These values are the foundation of our work, empowering us to make a real difference, every day.
Position Overview
The Associate Director, Digital Biomarker Lead will serve as the internal strategic and digital scientist SME for digital biomarker development, owning the pathway from concept of interest through endpoint qualification. This role sits at the intersection of clinical science, translational research, and operations -bridging the CMO, Clinical Study Teams, Biostats, Medical Affairs, and Regulatory Affairs to ensure that digital endpoints are scientifically credible, operationally viable, and aligned with evolving regulatory guidance.
This individual will lead digital biomarker strategy across therapeutic programs, building the evidence base for novel digital endpoints through literature synthesis, device landscape assessment, verification and validation study design, and regulatory briefing support. The ideal candidate brings deep knowledge of digital health measurement science together with the cross-functional leadership to drive alignment across a matrixed organization.
Key Responsibilities
- Serve as the primary Subject Matter Expert (SME) for digital biomarkers across the clinical development portfolio, partnering directly with the CMO, Clinical Study Teams, Medical Affairs, and Therapeutic Area leads to define digital biomarker objectives, establish Concepts of Interest (COIs), and translate them into Context of Use (COU) statements and measurement frameworks aligned with FDA DHT guidance and international regulatory standards.
- Lead digital biomarker strategy for assigned programs, including support with device landscape assessment, sensor technology evaluation with Prolaio, and endpoint development roadmaps spanning early proof-of-concept through pivotal trials.
- Conduct and synthesize systematic literature reviews to map aspects of health and COIs to candidate digital endpoints, characterize existing evidence on measurement properties, and identify benchmarks for meaningful change-informing both device selection and verification and validation study design.
- Design and oversee verification, validation, and usability studies in collaboration with Prolaio and other device partners, ensuring that digital endpoint evidence packages meet regulatory-grade evidentiary standards.
- Support the development of digital biomarker content for regulatory briefing books, and endpoint qualification submissions, and liaise with Regulatory Affairs, Biostats, Clinical Study Teams to develop qualification strategies and respond to Health Authority questions on digital measures.
- Monitor and interpret evolving regulatory guidance from FDA, EMA, and other global agencies on digital health technologies, digital endpoints, advising internal stakeholders on implications for ongoing and planned programs.
- Collaborate with the DHT Project Manager to ensure that digital biomarker strategy translates into executable study specifications, vendor requirements, and data standards; represent digital biomarker interests in Portfolio governance and DHT strategy & governance committee.
- Build and maintain relationships with external collaborators including academic partners, device vendors, and industry consortia, leveraging external expertise to accelerate internal programs and advance the company's position in the field.
- Contribute to internal capability-building through scientific training materials, best-practice documentation, and cross-functional education on digital biomarker science and regulatory expectations.
Qualifications
- MS or MPH in biomedical engineering, translational medicine, clinical pharmacology, neuroscience, movement science, or a closely related scientific discipline required; PhD strongly preferred.
- Minimum of 5-10 years of experience in pharma, biotech, medical device, or digital health, with at least 3-5 years of focused experience in digital biomarker or digital endpoint development.
- Demonstrated experience leading or contributing to end-to-end digital biomarker programs-from COI/COU definition through validation study execution and regulatory documentation.
- Deep familiarity with FDA DHT guidance, biomarker qualification frameworks, and relevant international regulatory standards.
- Experience designing studies involving wearable sensors, inertial measurement units, digital phenotyping tools, remote monitoring platforms, or related technologies, with strong scientific writing skills and experience contributing to regulatory documents or peer-reviewed publications.
- Demonstrated ability to influence and collaborate effectively across a matrixed, cross-functional organization spanning scientific, clinical, operational, and regulatory disciplines.
- Familiarity with analytical methods relevant to digital biomarker evaluation (e.g., signal processing, time-series analysis, mixed-effects models) and the ability to communicate technical concepts clearly to non-specialist audiences.
- Strong communication, relationship-building, and presentation skills.
- Comfort with regional and international travel (up to 25%).
Ideal Candidate Traits
- A scientifically rigorous, evidence-first thinker who translates complex measurement science into clear strategic recommendations for clinical and executive audiences.
- A natural cross-functional collaborator who builds trusted relationships across science, operations, and regulatory disciplines-and is comfortable both driving consensus and constructively challenging the status quo.
- Patient-centric in orientation, with a genuine commitment to developing endpoints that reflect what matters most to patients and that withstand regulatory scrutiny.
- Comfortable navigating ambiguity, moving between early exploratory science and the structured rigor of late-stage development and regulatory interactions.
- A proactive external networker who engages with industry working groups and consortia and brings external insight back to accelerate internal programs.
Exact Compensation may vary based on skills, experience and location.
Pay range
$170,000-$221,000 USD