Associate Director, Digital Biomarker Lead

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.