Principal Scientist, Translational Clinical Biomarkers
Pharma
Job description
Job Description We are seeking an accomplished and highly motivated Principal Scientist to provide strategic and scientific biomarker leadership across programs within the Neuroscience portfolio. This role will lead the design, execution, analysis, and communication of translational and clinical biomarker strategies across programs spanning early through late clinical development. The successful candidate will develop decision-centric biomarker strategies that integrate therapeutic mechanism, disease biology, pharmacodynamics, patient heterogeneity, dose and regimen selection, clinical endpoints, and opportunities for precision medicine. Biomarker plans will focus on generating high-value, interpretable evidence that informs program decisions and drive clinical development. Key Responsibilities: Develop and lead integrated biomarker strategies across Neuroscience programs, in partnership with cross-functional development teams. Translate disease biology and therapeutic mechanism into clear translational hypotheses and fit-for-purpose biomarker approaches. Define how biomarkers can inform key development questions including proof of biology, target engagement, dose and regimen selection, patient stratification, response assessment, and go/no-go decisions. Ensure biomarker strategies are focused and scalable, with clear linkage between the development question, proposed measurement, expected result, and potential action. Serve as the biomarker representative on cross-functional program teams and provide strategic biomarker input to program-level decision making. Partner closely with Discovery, Clinical Development, Quantitative Sciences, Regulatory, Data Science, Clinical Operations, and other functions to develop integrated translational strategies. Lead the interpretation of biomarker and clinical datasets and translate complex findings into clear, actionable recommendations. Identify opportunities to understand disease heterogeneity, therapeutic response, resistance or non-response, and biological drivers of clinical outcomes. Develop biomarker strategies to address areas such as target engagement, pathway modulation, disease biology, pharmacodynamic response, and patient stratification, utilizing modalities such as fluid sampling, imaging, or digital, as appropriate. Evaluate emerging biomarker technologies and analytical approaches based on their ability to address meaningful development questions. Communicate biomarker strategies, results, risks, and recommendations clearly to cross-functional teams and key stakeholders. Provide scientific guidance and mentorship to biomarker scientists and contribute to a collaborative, strategically focused biomarker organization. Drive publications, scientific presentations, external collaborations, and interactions with key external experts as appropriate. Qualifications Education: Ph.D., M.D., or equivalent advanced scientific degree with 10+ years of relevant experience in neuroscience, translational medicine, neurobiology, biomarker science, drug development, or a related discipline. Required Experience and Skills: Significant experience developing and executing translational or clinical biomarker strategies in drug development. Scientific expertise relevant to one or more areas within neuroscience, neurodegeneration, neurological disorders, psychiatry, or related disciplines. Demonstrated ability to translate scientific hypotheses into biomarker strategies that inform clinical development decisions. Strong understanding of the relationship between mechanism of action, disease biology, pharmacology, biomarkers, clinical endpoints, and development strategy. Ability to lead cross-functional scientific work in a matrixed environment and influence without direct authority. Strong analytical and problem-solving skills, including the ability to synthesize complex datasets into clear, decision-oriented conclusions. Ability to prioritize high-value, decision-enabling biomarker work and distinguish it from lower-priority exploratory activities. Excellent written and verbal communication skills and the ability to communicate scientific strategy to stakeholders. Working knowledge of biostatistics, bioinformatics, quantitative sciences, and multidimensional biomarker data analysis. Strategic mindset with a focus on scientific rigor, prioritization, scalability, and generation of actionable evidence. Preferred Experience and Skills: Experience supporting programs across multiple stages of clinical development. Experience with pharmacodynamic, predictive, prognostic, patient-stratification, or precision-medicine biomarker strategies. Experience in neuroscience drug development (e.g. neurodegenerative diseases like Alzheimer’s or Parkinson’s). Experience working across multiple programs or therapeutic areas. Experience mentoring or providing scientific direction to other scientists. Required Skills: Biomarkers, Clinical Development, Clinical Research, Clinical Study Design, Data Translation, Ethical Compliance, Ethical Standards, Mechanism of Action, Neurodegenerative Diseases, Neurological Disorders, Neuroscience, Patient Care, Personalized Medicine, Pharmacodynamics, Scientific Presentations, Scientific Writing, Strategic Thinking, Translational Medicine. Required Skills: Biomarker Development, Biomarker Discovery, Biomarker Identification, Biomarker Qualification, Biomarkers, Clinical Imaging, Clinical Pathology, Dedication to Patient Care, Disease Models, Disease Research, Imaging Biomarkers, Mechanism of Action, Medical Monitoring, Multiple Therapeutic Areas, Neurodegeneration, Neuroinflammation, Next Generation Science Standards, Personalized Medicine, Pharmaceutical Translations, Pharmacology, Professional Networking, Scientific Presentations, Scientific Writing, Translational Medicine Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: <p style="text-al
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