Astria Therapeutics Inc
AD/Dir, Quantitative Medicine Lead
Astria Therapeutics Inc, Boston, Massachusetts, us, 02298
Position Overview:
Astria Therapeutics is dedicated to bringing hope with life-changing therapies to patients and families affected by allergic and immunological diseases. Astria’s pipeline includes our lead program, Navenibart, a monoclonal antibody inhibitor of plasma kallikrein in clinical development for the treatment of hereditary angioedema, as well as STAR-0310, an OX40 monoclonal antibody antagonist currently in pre-clinical development for atopic dermatitis (AD) and being explored for other allergic and immunological diseases.
Astria Therapeutics is seeking a talented Quantitative Medicine Lead to join our team. This role will focus on utilizing diverse modeling approaches to address key drug development questions. The ideal candidate will integrate preclinical, clinical, literature, and competitive data to inform decision-making processes and drive innovative therapeutic solutions. This position requires a strong background in quantitative analysis and a passion for improving patient outcomes through data-driven insights.
The incumbent will contribute to cross-functional collaboration, regulatory submissions, and engagement with external stakeholders, ensuring that the clinical strategy aligns with Astria’s mission to deliver life-changing therapies to patients with unmet medical needs.
Responsibilities:
Develop and implement quantitative models that integrate diverse data sources, including preclinical, clinical, and real-world evidence, to address critical drug development questions (e.g., dose/schedule selection, combinations, biomarker identification, patient selection, clinical trial design, go/no-go decisions).
Synthesize and analyze data from multiple sources, including literature and competitor analysis, to generate actionable insights that support project goals.
Perform pharmacokinetic and pharmacodynamic data analysis, utilizing both non-compartmental and compartmental methods to derive key PK/PD parameters from clinical trials.
Conduct data analysis to identify and select the most appropriate patient populations for clinical trials, ensuring alignment with trial objectives and improving the likelihood of success in target subgroups.
Implement various exposure-based, biological, and quantitative modeling and simulation approaches (Pharmacometrics (PopPK, PKPD, E~R), Mechanistic Modeling (QSP, PBPK), Biomarkers, Model-Based Meta-Analysis, Machine Learning/Artificial Intelligence and Clinical trial simulations) for clinical trial simulations and decision-making.
Coordinate and manage modeling vendors to ensure timely and high-quality deliverables.
Internalize models developed by vendors for real-time data analysis, ensuring they align with internal standards and objectives.
Collaborate with cross-functional teams to ensure quantitative findings are effectively communicated, aligned with scientific objectives, and incorporated into development plans.
Provide quantitative support for drug development decision-making, identifying opportunities, risks, and uncertainties through advanced modeling techniques.
Present complex quantitative findings to internal stakeholders, ensuring clarity, understanding, and relevance for informed decision-making.
Qualifications:
PhD degree in a quantitative discipline (e.g., Pharmacology, Biostatistics, Data Science, Computational Biology).
5 + years of experience with strong proficiency in pharmacokinetic/pharmacodynamic (PK/PD) analysis, including both non-compartmental and compartmental methodologies.
Proven experience with various modeling and simulation approaches, including population PK (PopPK), mechanistic modeling (e.g., QSP, PBPK), exposure-response (E-R), and clinical trial simulations.
Experience in machine learning, artificial intelligence, or model-based meta-analysis is highly desirable.
Ability to manage and collaborate with external vendors and cross-functional internal teams.
Strong problem-solving skills, with the ability to synthesize diverse data sources into actionable insights.
Excellent communication skills with the ability to clearly present complex quantitative concepts to non-technical stakeholders.
Familiarity with clinical trial design and regulatory requirements in drug development is a plus
Astria’s Commitment:
At Astria, we are committed to building a diverse team where every Astrian endorses the idea that people bring their authentic self to work. We embrace a patient-first, people-always culture which strives to ensure all Astrians and our collaborators have a sense of belonging and receive the support they need to thrive. We invest in our people through our words, our actions, and our values. We are working to develop and implement initiatives that promote diversity, equity, and inclusion throughout the organization and foster a culture of openness, respect, and collaboration, where all voices are heard, and everyone is valued for their unique perspectives and contributions.
People are our greatest asset, and only with a diverse team can Astria shine brighter. Together we can bring our passion and compassion to the work of delivering life-changing therapies to patients, families, and communities.
#LI-Hybrid
#J-18808-Ljbffr
Astria Therapeutics is dedicated to bringing hope with life-changing therapies to patients and families affected by allergic and immunological diseases. Astria’s pipeline includes our lead program, Navenibart, a monoclonal antibody inhibitor of plasma kallikrein in clinical development for the treatment of hereditary angioedema, as well as STAR-0310, an OX40 monoclonal antibody antagonist currently in pre-clinical development for atopic dermatitis (AD) and being explored for other allergic and immunological diseases.
Astria Therapeutics is seeking a talented Quantitative Medicine Lead to join our team. This role will focus on utilizing diverse modeling approaches to address key drug development questions. The ideal candidate will integrate preclinical, clinical, literature, and competitive data to inform decision-making processes and drive innovative therapeutic solutions. This position requires a strong background in quantitative analysis and a passion for improving patient outcomes through data-driven insights.
The incumbent will contribute to cross-functional collaboration, regulatory submissions, and engagement with external stakeholders, ensuring that the clinical strategy aligns with Astria’s mission to deliver life-changing therapies to patients with unmet medical needs.
Responsibilities:
Develop and implement quantitative models that integrate diverse data sources, including preclinical, clinical, and real-world evidence, to address critical drug development questions (e.g., dose/schedule selection, combinations, biomarker identification, patient selection, clinical trial design, go/no-go decisions).
Synthesize and analyze data from multiple sources, including literature and competitor analysis, to generate actionable insights that support project goals.
Perform pharmacokinetic and pharmacodynamic data analysis, utilizing both non-compartmental and compartmental methods to derive key PK/PD parameters from clinical trials.
Conduct data analysis to identify and select the most appropriate patient populations for clinical trials, ensuring alignment with trial objectives and improving the likelihood of success in target subgroups.
Implement various exposure-based, biological, and quantitative modeling and simulation approaches (Pharmacometrics (PopPK, PKPD, E~R), Mechanistic Modeling (QSP, PBPK), Biomarkers, Model-Based Meta-Analysis, Machine Learning/Artificial Intelligence and Clinical trial simulations) for clinical trial simulations and decision-making.
Coordinate and manage modeling vendors to ensure timely and high-quality deliverables.
Internalize models developed by vendors for real-time data analysis, ensuring they align with internal standards and objectives.
Collaborate with cross-functional teams to ensure quantitative findings are effectively communicated, aligned with scientific objectives, and incorporated into development plans.
Provide quantitative support for drug development decision-making, identifying opportunities, risks, and uncertainties through advanced modeling techniques.
Present complex quantitative findings to internal stakeholders, ensuring clarity, understanding, and relevance for informed decision-making.
Qualifications:
PhD degree in a quantitative discipline (e.g., Pharmacology, Biostatistics, Data Science, Computational Biology).
5 + years of experience with strong proficiency in pharmacokinetic/pharmacodynamic (PK/PD) analysis, including both non-compartmental and compartmental methodologies.
Proven experience with various modeling and simulation approaches, including population PK (PopPK), mechanistic modeling (e.g., QSP, PBPK), exposure-response (E-R), and clinical trial simulations.
Experience in machine learning, artificial intelligence, or model-based meta-analysis is highly desirable.
Ability to manage and collaborate with external vendors and cross-functional internal teams.
Strong problem-solving skills, with the ability to synthesize diverse data sources into actionable insights.
Excellent communication skills with the ability to clearly present complex quantitative concepts to non-technical stakeholders.
Familiarity with clinical trial design and regulatory requirements in drug development is a plus
Astria’s Commitment:
At Astria, we are committed to building a diverse team where every Astrian endorses the idea that people bring their authentic self to work. We embrace a patient-first, people-always culture which strives to ensure all Astrians and our collaborators have a sense of belonging and receive the support they need to thrive. We invest in our people through our words, our actions, and our values. We are working to develop and implement initiatives that promote diversity, equity, and inclusion throughout the organization and foster a culture of openness, respect, and collaboration, where all voices are heard, and everyone is valued for their unique perspectives and contributions.
People are our greatest asset, and only with a diverse team can Astria shine brighter. Together we can bring our passion and compassion to the work of delivering life-changing therapies to patients, families, and communities.
#LI-Hybrid
#J-18808-Ljbffr