PharmaEssentia
Senior/Principal Scientist, Translational Sciences
PharmaEssentia, Bedford, Massachusetts, us, 01730
Senior/Principal Scientist, Translational Sciences
Overview
PharmaEssentia Innovation Research Center (PIRC) seeks a highly motivated senior or principal scientist to join the Translational Sciences team and contribute to the development of first-in-class and best-in-class biotherapeutics, including cytokines, antibodies, and antibody-drug-conjugates. The candidate will contribute to the design, execution, and interpretation of translational biomarker and mechanism of action (MOA) studies to support development and regulatory approval as therapeutics transition from late discovery into first-in-human trials and beyond. You will utilize expertise in pharmacokinetics, pharmacodynamics, and biomarker discovery to guide drug development and biomarker strategies, optimize dosing regimens, and ensure safety and efficacy of investigational drugs. You will also contribute to translational activities aimed at maximizing the potential of BESREMi, PharmaEssentia’s marketed drug for the treatment of myeloproliferative neoplasms, including indication expansion, novel combinations, and refining biomarker approaches for dosing and patient selection. You will provide scientific leadership, mentorship, and cross-functional collaboration within Translational Sciences and across other departments.
Responsibilities
Study Design and Execution: Lead the design, planning, and execution of translational studies in indication-relevant animal models and primary human cellular and tissue systems to identify and validate biomarkers and explore MOA. Collaborate with cross-functional teams to align with discovery, development goals, and regulatory requirements.
Further Exploration of BESREMi: Collaborate with clinical development to explore BESREMi potential in MPN and other oncologic areas. Conduct translational studies internally and participate in investigator-initiated trials (IITs) or company-sponsored trials to maximize clinical potential.
Data Analysis and Interpretation: Oversee analysis, interpretation, and reporting of in vitro and in vivo pharmacology/translational biomarker data, including pharmacokinetic and pharmacodynamic parameters, exposure–response relationships, and safety/tolerability profiles. Provide scientific insights to inform decision-making and optimize outcomes.
Drug Development Strategy: Contribute to the development and implementation of clinical pharmacology strategies to support progression of investigational drugs through all phases of development. Generate rationale for dose selection, formulation optimization, and target validation.
Regulatory Interaction: Work with regulatory affairs to support regulatory submissions (INDs, NDAs, and MAAs). Address inquiries and provide scientific justifications for study designs, endpoints, and data analyses.
Scientific Leadership: Serve as a subject-matter expert in translational biomarkers, target biology, and MOA; provide guidance and mentorship to junior scientists, clinicians, and project teams. Contribute to scientific literature through publications, presentations, and conferences.
Cross-Functional Collaboration: Collaborate with data sciences, biologics, immunology/pharmacology, clinical development, and regulatory affairs to integrate translational biomarker and MOA insights into drug development strategies. Foster scientific excellence and collaboration.
Qualifications
Ph.D. in oncology, immunology, immuno-oncology, pharmacology, pharmaceutical sciences, or related discipline.
3+ years of experience for Senior Scientist or 8+ years for Principal Scientist in the pharmaceutical or biotechnology industries, with a proven track record of leadership and achievement in translational sciences.
Expertise in in vivo model design and biomarker discovery, including internal work and collaborations with contract research organizations and academic collaborations.
Experience with primary human cellular/tissue-based assays to guide indication selection, biomarker discovery and mechanism of action.
Experience with immuno-oncology and autoimmune disease/chronic inflammation targets and associated in vitro and in vivo models is preferred.
Experience in clinical trial design and/or clinical operations in either company-sponsored or IIT clinical trials is strongly desirable.
Strong analytical skills, with proficiency in pharmacokinetic/pharmacodynamic software (e.g., NONMEM, Phoenix WinNonlin, R) is preferred.
Experience working closely with academic collaborators via sponsored research agreements or IITs is preferred.
Excellent communication and presentation skills, with the ability to effectively convey complex scientific concepts to diverse audiences.
Demonstrated leadership capabilities, including the ability to mentor and develop talent, foster teamwork, and drive results in a dynamic environment.
Job Details
Location: Bedford, MA
Seniority level: Mid-Senior level
Employment type: Full-time
Job function: Research, Analyst, and Information Technology
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Responsibilities
Study Design and Execution: Lead the design, planning, and execution of translational studies in indication-relevant animal models and primary human cellular and tissue systems to identify and validate biomarkers and explore MOA. Collaborate with cross-functional teams to align with discovery, development goals, and regulatory requirements.
Further Exploration of BESREMi: Collaborate with clinical development to explore BESREMi potential in MPN and other oncologic areas. Conduct translational studies internally and participate in investigator-initiated trials (IITs) or company-sponsored trials to maximize clinical potential.
Data Analysis and Interpretation: Oversee analysis, interpretation, and reporting of in vitro and in vivo pharmacology/translational biomarker data, including pharmacokinetic and pharmacodynamic parameters, exposure–response relationships, and safety/tolerability profiles. Provide scientific insights to inform decision-making and optimize outcomes.
Drug Development Strategy: Contribute to the development and implementation of clinical pharmacology strategies to support progression of investigational drugs through all phases of development. Generate rationale for dose selection, formulation optimization, and target validation.
Regulatory Interaction: Work with regulatory affairs to support regulatory submissions (INDs, NDAs, and MAAs). Address inquiries and provide scientific justifications for study designs, endpoints, and data analyses.
Scientific Leadership: Serve as a subject-matter expert in translational biomarkers, target biology, and MOA; provide guidance and mentorship to junior scientists, clinicians, and project teams. Contribute to scientific literature through publications, presentations, and conferences.
Cross-Functional Collaboration: Collaborate with data sciences, biologics, immunology/pharmacology, clinical development, and regulatory affairs to integrate translational biomarker and MOA insights into drug development strategies. Foster scientific excellence and collaboration.
Qualifications
Ph.D. in oncology, immunology, immuno-oncology, pharmacology, pharmaceutical sciences, or related discipline.
3+ years of experience for Senior Scientist or 8+ years for Principal Scientist in the pharmaceutical or biotechnology industries, with a proven track record of leadership and achievement in translational sciences.
Expertise in in vivo model design and biomarker discovery, including internal work and collaborations with contract research organizations and academic collaborations.
Experience with primary human cellular/tissue-based assays to guide indication selection, biomarker discovery and mechanism of action.
Experience with immuno-oncology and autoimmune disease/chronic inflammation targets and associated in vitro and in vivo models is preferred.
Experience in clinical trial design and/or clinical operations in either company-sponsored or IIT clinical trials is strongly desirable.
Strong analytical skills, with proficiency in pharmacokinetic/pharmacodynamic software (e.g., NONMEM, Phoenix WinNonlin, R) is preferred.
Experience working closely with academic collaborators via sponsored research agreements or IITs is preferred.
Excellent communication and presentation skills, with the ability to effectively convey complex scientific concepts to diverse audiences.
Demonstrated leadership capabilities, including the ability to mentor and develop talent, foster teamwork, and drive results in a dynamic environment.
Job Details
Location: Bedford, MA
Seniority level: Mid-Senior level
Employment type: Full-time
Job function: Research, Analyst, and Information Technology
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