Current jobs related to Director, PK/PD/PMX - Boston - Fusion Pharmaceuticals

  • Principal Clinical Pharmacology Expert

    1 week ago

    Boston, Massachusetts, United States Regeneron Pharmaceuticals Full time

    Job SummaryWe are seeking a highly motivated Principal Scientist, Clinical Pharmacology to join our Pharmacometrics (PMx) group. The successful candidate will report to the Senior Group Director (SGD) within Clinical Pharmacology (CP) in the General Medicine (GM) group.Key ResponsibilitiesRepresent CP on project teams to provide strategic and scientific...

  • Senior Director, Quantitative Pharmacology Expert

    2 weeks ago

    Boston, New York, United States Regeneron Pharmaceuticals Full time

    Job SummaryWe are seeking a highly experienced Senior Director to lead our Quantitative Pharmacology team. As a key member of our Pharmacometrics department, you will be responsible for managing PMx support for multiple programs across various therapeutic areas.Key ResponsibilitiesDevelop and implement strategic analyses in support of research and...

  • Senior Director, Quantitative Pharmacology Expert

    5 days ago

    Boston, New York, United States Regeneron Pharmaceuticals Full time

    Job SummaryRegeneron Pharmaceuticals is seeking a highly experienced Senior Director to lead our Pharmacometrics team. As a key member of our organization, you will be responsible for managing PMx support for multiple programs across various therapeutic areas. Your expertise in pharmacokinetics and pharmacodynamics will drive strategic analyses in support of...

  • Director of Quantitative Pharmacology

    2 weeks ago

    Boston, New York, United States Regeneron Pharmaceuticals Full time

    Director Quantitative PharmacologyRegeneron Pharmaceuticals is seeking a highly skilled Director to lead our Pharmacometrics team.Key Responsibilities:Deliver support for research and development programs within the pharmacometrics discipline.Provide timely and accurate quantitative analyses, interpretation, and messaging to PMx management.Develop and...

  • PK/PD and QSP Modeler, Neuroscience

    2 weeks ago

    Boston, Georgia, United States Takeda Pharmaceutical Full time

    About the RoleTakeda is a forward-thinking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. As a PK/PD and QSP modeler, Neuroscience - Senior Scientist, you will be empowered to interface between biology/pharmacology, chemistry/biologics, nonclinical safety assessment, drug metabolism, translational...

  • PK/PD and QSP Modeler, Neuroscience – Senior Scientist, DMPK

    2 weeks ago

    Boston, Massachusetts, United States Takeda Pharmaceutical Full time

    About the RoleTakeda is a forward-thinking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients worldwide. We are seeking a highly skilled PK/PD and QSP modeler to join our team in Cambridge, MA.Key ResponsibilitiesDevelop a quantitative model of novel therapeutic agents to treat various neurological...

  • PK/PD and QSP Modeler, Neuroscience – Senior Scientist, DMPK

    2 weeks ago

    Boston, Massachusetts, United States Takeda Pharmaceutical Full time

    About the Role:Takeda is a forward-thinking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients worldwide. We are seeking a highly skilled PK/PD and QSP modeler to join our team in Cambridge, MA.Key Responsibilities:Develop and implement quantitative models of novel therapeutic agents to treat neurological...

  • Associate Director, Quantitative Clinical Pharmacology Lead

    2 weeks ago

    Boston, Massachusetts, United States Takeda Pharmaceutical Full time

    Transforming Healthcare through Data-Driven InsightsTakeda Pharmaceutical is seeking a highly skilled Associate Director, Quantitative Clinical Pharmacology to join our Data Sciences Institute in Cambridge, MA. As a key member of our team, you will play a critical role in harnessing the power of data and digital tools to speed the development of innovative...

  • Pharmacokinetics Dynamics and Metabolism PKDM Associate Director

    3 weeks ago

    Boston, Massachusetts, United States KP Recruiting Group Full time

    Job Title: Pharmacokinetics Dynamics and Metabolism PKDM Associate DirectorKP Recruiting Group is a leading consulting firm that provides exceptional talent to some of the world's leading companies. Headquartered in the Midwest, we have successfully completed countless engagements across the United States. Our mission is to provide exceptional client and...

  • Clinical Pharmacology Director

    2 weeks ago

    Boston, Massachusetts, United States Vertex Pharmaceuticals Full time

    Job DescriptionThe Director of Clinical Pharmacology plays a pivotal role in leading strategic, scientific, and operational aspects at a program level. This role represents the department on strategic and operational cross-functional program teams and is responsible for developing clinical pharmacology plans. The Director assists in departmental management...

  • Clinical Pharmacology Associate Director

    1 week ago

    Boston, Massachusetts, United States Vertex Full time

    Job SummaryThe Clinical Pharmacology Associate Director plays a crucial role in managing scientific and operational aspects at a study level and assisting development at a program level. This individual will represent the department on cross-functional study teams and contribute toward clinical pharmacology plans. The ideal candidate will have expertise in...

  • Director of Quantitative Pharmacology

    3 weeks ago

    Boston, New York, United States Regeneron Pharmaceuticals Full time

    Director Quantitative Pharmacology Job DescriptionRegeneron Pharmaceuticals is seeking a highly skilled Director to join our Pharmacometrics team. As a key member of our team, you will be responsible for delivering support for one or more research & development programs within your pharmacometrics discipline.Key Responsibilities:Manage and be accountable for...

  • Pharmacokinetics Dynamics and Metabolism PKDM ociate Director

    1 month ago

    Boston, United States KP Recruiting Group Full time

    KP Recruiting Group is a consulting firm that provides leadership and exceptional talent to some of the world s leading companies. Headquartered in the Midwest KP Recruiting Group has successfully completed countless engagements across the United States. We represent clients in all industries and all sizes. Our mission is to provide exceptional...

  • Pharmacokinetics Dynamics and Metabolism PKDM ociate Director

    4 weeks ago

    Boston, United States KP Recruiting Group Full time

    KP Recruiting Group is a consulting firm that provides leadership and exceptional talent to some of the world s leading companies. Headquartered in the Midwest KP Recruiting Group has successfully completed countless engagements across the United States. We represent clients in all industries and all sizes. Our mission is to provide exceptional...

  • Pharmacokinetics and Metabolism Specialist

    2 weeks ago

    Boston, Massachusetts, United States KP Recruiting Group Full time

    Job OverviewAt KP Recruiting Group, we are seeking a highly skilled Pharmacokinetics and Metabolism Specialist to join our team. This role will be responsible for generating, integrating, and leveraging clinical and non-clinical PK, PK/PD, and metabolism knowledge to support critical decision making and risk management for projects from first in human dosing...

  • Senior Pharmacokinetics Expert

    5 days ago

    Boston, Massachusetts, United States KP Recruiting Group Full time

    Senior Pharmacokinetics Expert - Drug Development and RegulationAt KP Recruiting Group, we are seeking a highly skilled Senior Pharmacokinetics Expert to join our team. This is a confidential role that we are excited to present to a qualified candidate.Our client offers a hybrid work schedule with 23 days a week in-office, providing a great work-life...

  • Pharmacokinetics Dynamics and Metabolism PKDM ociateDirector

    4 weeks ago

    Boston, United States KP Recruiting Group Full time

    KP Recruiting Group is aconsulting firm that provides leadership and exceptional talent tosome of the world s leading companies. Headquartered in the MidwestKP Recruiting Group has successfully completed countlessengagements across the United States. We represent clients in allindustries and all sizes. Our mission is to provide exceptionalclient and...

  • Senior Clinical Pharmacology Leader

    2 weeks ago

    Boston, Massachusetts, United States AbbVie Full time

    Job SummaryAbbVie is seeking a highly skilled Senior Clinical Pharmacology Leader to join our team. As a key member of our Clinical Pharmacology department, you will be responsible for conceiving, executing, and managing multi-disciplinary development plans and strategies that achieve commercial goals and regulatory requirements.Key ResponsibilitiesGenerate...

  • Senior Director, Quantitative Pharmacology Expert

    3 weeks ago

    Boston, New York, United States Regeneron Pharmaceuticals Full time

    Job SummaryAs a Senior Director in Pharmacometrics, this individual will be responsible for managing PMx support for a number of programs in one or more therapeutic focus areas of the development portfolio. In this capacity, the Senior Director is accountable for the successful and timely completion of all assignments encompassing a broad array of...

  • Scientific Director, Global DMPK&M

    2 weeks ago

    Boston, Massachusetts, United States Takeda Pharmaceutical Full time

    About the RoleTakeda Pharmaceutical is seeking a highly skilled and experienced Scientific Director to lead our Global DMPK and Modeling team. As a key member of our research and development organization, you will be responsible for driving strategic and tactical initiatives to support the delivery of our pipeline across GI, Neuroscience, and Oncology.The...

Director, PK/PD/PMX

4 months ago

Boston, United States Fusion Pharmaceuticals Full time

Fusion Pharmaceuticals, a member of the AstraZeneca Group, is a clinical-stage oncology company focused on developing next-generation radioconjugates (RCs) as precision medicines. Fusion connects alpha particle emitting isotopes to various targeting molecules to selectively deliver the alpha emitting payloads to tumors. Fusion’s clinical portfolio includes: FPI-2265 targeting prostate specific membrane antigen (PSMA) for metastatic castration resistant prostate cancer currently in a Phase 2 trial; FPI-1434 targeting insulin-like growth factor 1 receptor currently in a Phase 1 trial; FPI-2059, a small molecule targeting neurotensin receptor 1 (NTSR1), currently in a Phase 1 trial; and FPI-2068, a bispecific IgG-based EGFR-cMET targeted radioconjugate currently in a Phase 1 trial. In addition, Fusion is pursuing combination programs between RCs and DNA Damage Response Inhibitors (DDRis) and immune-oncology agents. Fusion has a fully operational Good Manufacturing Practice (GMP) compliant state-of-the-art radiopharmaceutical manufacturing facility to meet supply demand for Fusion's growing pipeline of RCs.


The Director, PK/PD/PMX will be responsible for leading efforts to analyze, interpret, and model pharmacokinetic/pharmacodynamic, safety, efficacy, and dosimetry data to support preclinical and clinical program teams. The incumbent will be responsible for building a preeminent group dedicated to the modeling and simulation of radiopharmaceutical products.This role will be highly crossfunctional in nature and will seek to synthesize data and information from multiple sources to inform critical decisions and influence decisions related to dose levels and regimens, preclinical to clinical translation, and determination of therapeutic index. Successful candidates will have demonstrated the potential to design and execute fit-for-purpose PK/PD analysis/modeling efforts with impact on significant decisions and outcomes on discovery/development teams.


Responsibilities:

  • The Director, PK/PD/PMX will provide scientific leadership through analysis and interpretation of PK/PD and dosimetry data in support of preclinical, translational, and clinical studies and programs
  • Lead efforts to translate preclinical data to the clinical setting by integrating data from internal and external sources project PK/PD, PBPK, and safety properties of targeted alpha therapies in humans
  • Interpret, analyze, and model quantitative data to support the selection of targets, molecules, dose levels or regimens, patient populations, and development strategies for novel radiopharmaceuticals
  • Using PMX, anticipate the high-level issues associated with the development radiopharmaceuticals and help derive effective solutions. Support decision-making and implement solutions through proactive communication and collaboration on cross-functional teams.
  • Plan, develop and execute PK/PD, PBPK strategies of program and product team
  • Lead and support the preparation and delivery of relevant portions of Phase I, II, and III study protocols, analysis plans, data interpretation, and study reports
  • Responsible for preparation of relevant INDs, IBs, CTDs and other regulatory documents for development and registration of new drugs and line extensions across multiple geographies. This may involve direct interaction with FDA, EMA, and PMDA, among other regulatory agencies.
  • Provide coaching and mentoring to other scientists within the department and across the company as well as interact, teach, and collaborate with the broader research community
  • Represent the group to increase visibility externally through key publications and active leadership in key scientific organizations


Qualifications:

  • PhD in in Computer Science, Mathematics, Engineering, Pharmaceutical Sciences, or a degree in another research area relevant to PK/PD/Pharmacometrics and 8+ years of industry experience. Alternatively, a BS/MS degree and 10+ years of relevant industry experience.
  • Excellent technical knowledge of pharmacokinetic principles and data analysis/model building
  • Direct experience in modeling PK/PD data by applying at least one of the following: population PK/PD, physiologically based pharmacokinetic (PBPK) modeling, target-mediated drug disposition (TMDD), or quantitative systems pharmacology (QSP)
  • Ability to lead PK/PD/PMX efforts across multiple programs and modalities and to communicate the results and implications of findings with crossfunctional program teams
  • Excellent interpersonal skills that lead to successful collaborative working relationships with key colleagues across the organization including clinical, discovery, and management
  • Understanding of the drug discovery and development process and how PK/PD/PMX can inform drug discovery/development and address key questions
  • Desire to carry out scientific development and research work with a view to publishing collaboratively
  • Strong customer focus with the ability to have robust discussions with project leaders to ensure that project, scientific and resource demands are aligned.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.