Senior Director, DMPK

3 weeks ago

Boston, United States EPM Scientific Full time
Job DescriptionJob Description

Sr. Director, DMPK, Global Pharmaceutical Company

  • Gastrointestinal | Immunology | Pharmacology
  • Greater Boston Area
  • $275,000 - $320,000 + bonus +complete benefits package

A global pharmaceutical company is driving forward as a cutting-edge R&D organization, focused on pushing the boundaries of innovation to deliver transformative therapies to patients. With a commitment to research and development in key therapeutic areas, this company strives to bring groundbreaking treatments to those in need across the globe.

Qualifications

  • PhD with 15+ years of industry experience, or equivalent experience.
  • In-depth knowledge of Inflammation & Immunology project portfolios, disease indications, and drug metabolism/pharmacokinetics (DMPK) considerations.
  • Familiarity with various modalities such as small molecules, ASOs, gene therapy, cell therapy, and biologics.
  • Extensive experience across all phases of drug development, from discovery through post-market support.
  • Proven ability to provide strategic recommendations to senior management for key program decisions.
  • Expertise in regulatory submissions (INDs, CTAs, NDAs, MAAs) and experience interfacing with regulatory bodies such as the FDA, EMA, and PMDA, in collaboration with the Regulatory function.

Responsibilities

  • Act as a key representative of Inflammation & Immunology within the DMPK&M Leadership Team.
  • Actively participate in DMPK leadership meetings to provide updates on therapeutic areas, key issues, and progress milestones.
  • Lead operational and strategy meetings involving DMPK staff working on the Inflammation & Immunology portfolio.
  • Oversee study protocol reviews, supporting DMPK Project Team Representatives in experimental design and data interpretation.
  • Review study reports and regulatory documents for scientific accuracy and alignment with human risk assessments.
  • Provide ongoing mentorship and performance feedback to DMPK Project Team Representatives.
  • Engage with the Global Head of DMPK, partnership leads, and functional heads to address strategic questions and resolve potential challenges.
  • Provide strategic leadership for the Inflammation & Immunology portfolio within DMPK, making high-level decisions in consultation with senior leadership.
  • Ensure the scientific and strategic soundness of clinical candidates, optimizing their development and characterization.
  • Offer guidance on drug metabolism, bioanalysis, biomarkers, pharmacokinetics (PK), and PK/PD considerations at various stages of drug development.
  • Ensure efficient execution of studies that support drug candidates within the portfolio.
  • Provide scientific and strategic input to DMPK Project Team Representatives, supporting the development of therapeutic assets.
  • Approve DMPK strategy components for all projects at critical milestones and review sections of internal project documentation.
  • Stay informed on the latest competitive and regulatory trends in relevant therapeutic areas.
  • Coordinate goals and resource allocation with leadership and communicate needs to DMPK functional leaders.
  • Work closely with heads of ADME, Bioanalytical, Biomarker, and Translational Partner teams to ensure appropriate staffing for projects at critical stages.
  • Review and approve regulatory documents on behalf of DMPK.

Education & Competencies

  • PhD with 15+ years of industry experience, or equivalent experience.
  • Strong understanding of Inflammation & Immunology portfolio, disease areas, and relevant DMPK considerations for patients.
  • Experience working with various therapeutic modalities including small molecules, ASOs, gene therapy, cell therapy, and biologics.
  • Comprehensive experience across all stages of drug development, from discovery through to market support.
  • Ability to provide strategic program recommendations to senior management.
  • Experience with regulatory submissions (INDs, CTAs, NDAs, MAAs) and regulatory authority interactions (FDA, EMA, PMDA), with expertise in developing strategies for these interfaces in collaboration with Regulatory Affairs.

Company DescriptionA top 10 pharmaceutical company with an immense amount of growth after releasing their at home COVID diagnostic tests is looking to bring on 200+ Quality Individuals through a massive hiring campaign. In their search for Quality Specialists, the organization is looking for individuals who will be responsible for reviewing and actioning customer complaints, as well as investigation into said complaints.
Job Responsibilities:
•\tConducting Post Market Activities and Post Market Surveillance
•\tManaging Customer and Product Complaint Investigation programs
Education and Experience:
•\t1 YR. of experience in a technical role in the medical device/pharma/biotech industry
•\tBachelor's degree
•\tComputer proficiencyCompany DescriptionA top 10 pharmaceutical company with an immense amount of growth after releasing their at home COVID diagnostic tests is looking to bring on 200+ Quality Individuals through a massive hiring campaign. In their search for Quality Specialists, the organization is looking for individuals who will be responsible for reviewing and actioning customer complaints, as well as investigation into said complaints.\r
Job Responsibilities:\r
•\tConducting Post Market Activities and Post Market Surveillance\r
•\tManaging Customer and Product Complaint Investigation programs\r
Education and Experience:\r
•\t1 YR. of experience in a technical role in the medical device/pharma/biotech industry\r
•\tBachelor's degree\r
•\tComputer proficiency

  • Senior Director DMPK

    2 months ago

    Boston, United States ARTO Full time

    Position: Director DMPK Project LeadershipLocation: USADepartment: Research & DevelopmentWe are currently working with a Global Pharmaceutical company, with a highly developing pipeline consisting of early and late stage developments within Oncology, Immunology and Neurology. Despite their portfolio of marketed drugs, the company is still focused on its...

  • Senior Director DMPK

    2 months ago

    Boston, United States ARTO Full time

    Position: Director DMPK Project LeadershipLocation: USADepartment: Research & DevelopmentWe are currently working with a Global Pharmaceutical company, with a highly developing pipeline consisting of early and late stage developments within Oncology, Immunology and Neurology. Despite their portfolio of marketed drugs, the company is still focused on its...

  • Senior Scientist DMPK Project Lead

    4 weeks ago

    Boston, Massachusetts, United States Takeda Pharmaceutical Full time

    Senior Scientist DMPK Project Lead Job DescriptionTakeda Pharmaceutical is seeking a highly skilled Senior Scientist DMPK Project Lead to join our Global DMPK organization. As a key member of our team, you will be responsible for leading DMPK projects and providing strategic guidance to ensure the successful development of new medicines.Key...

  • Scientific Director, Global DMPK&M

    5 days ago

    Boston, Massachusetts, United States Takeda Pharmaceutical Full time

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

  • Scientific Director, Global DMPK&M

    5 days 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...

  • Senior Scientist, DMPK Project Lead

    5 days ago

    Boston, Massachusetts, United States Takeda Pharmaceutical Full time

    Job DescriptionAs a Senior Scientist, DMPK Project Lead, you will be responsible for leading cross-functional project teams in the development of new medicines. You will work closely with scientists, engineers, and other stakeholders to design and execute experiments, analyze data, and develop strategies to overcome technical challenges.Key...

  • Senior Director, Drug Metabolism and Pharmacokinetics

    5 days ago

    Boston, Massachusetts, United States Takeda Pharmaceutical Full time

    Job DescriptionAt Takeda Pharmaceutical, we are a forward-thinking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. Our team is dedicated to pushing the boundaries of what is possible in order to bring life-changing treatments to patients worldwide.Key ResponsibilitiesRepresent the GI2 (Inflammation &...

  • Director of Pharmacokinetics and Pharmacodynamics

    2 days ago

    Boston, Massachusetts, United States Covant Full time

    Scientific Leadership OpportunityCovant Therapeutics is seeking a highly skilled Director/Senior Director, Drug Metabolism and Pharmacokinetics, to lead our scientific efforts in characterizing pharmacokinetic properties of drug candidates.Key Responsibilities:Scientific oversight of our portfolio and management of in vitro and in vivo PK, ADME, and...

  • Senior Director of Preclinical Development

    5 days ago

    Boston, Massachusetts, United States Frontier Medicines Full time

    Job SummaryFrontier Medicines is seeking a seasoned leader to join our team as Senior Director/Executive Director, Head of Preclinical Development. This role will play a pivotal part in advancing our non-clinical strategy and overseeing the execution of multiple drug discovery programs to advance our innovative pipeline of "undruggable" targets into the...

  • Senior Director of IT

    3 months ago

    Boston, United States Tandym Group Full time

    An emerging biotech company in Massachusetts is looking to an experienced IT professional to their team as their new Senior Director of IT. In this role, the Senior Director of IT will have broad responsibility for IT strategy, planning, end user services, infrastructure (with a cloud-first mentality), cyber security, and business applications. ...

  • Senior Director of Financial Planning and Analysis

    4 weeks ago

    Boston, United States Five Star Senior Living Full time

    Key Responsibilities About the Team We're a team of mission-driven individuals with a hunger for purposeful innovation and making a difference in the lives of others. We keep our values of People First, Trust Matters, Moving Forward and Passion for Life at the center of what we do and who it serves- our people. We welcome diversity of backgrounds, ideas and...

  • Scientific Director, Research

    7 hours ago

    Boston, United States Takeda Pharmaceuticals Full time

    About the role:At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on three therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.Are you...

  • Associate Director/Director Medicinal Chemistry

    3 weeks ago

    Boston, United States Kestrel Therapeutics Full time

    Associate Director/Director, Medicinal ChemistryAt Kestrel, our mission is to invent cutting-edge technologies and develop novel small molecule agents targeting critical cancer pathways. Our focus is on mutant RAS, cancer's most frequently mutated oncogenic target. We are committed to rigorously applying innovative science to discover new medicines for...

  • Senior Director of IT Operations

    5 days ago

    Boston, Massachusetts, United States Tandym Group Full time

    A forward-thinking biotech company in Massachusetts is seeking a seasoned IT professional to spearhead their technology strategy as their new Senior Director of IT.In this pivotal role, the Senior Director of IT will oversee the development and execution of a comprehensive IT strategy, driving innovation and growth across the organization.Key...

  • Senior Care Professional

    4 days ago

    South Boston, United States Commonwealth Senior Living Full time

    Senior Care ProfessionalWe are seeking a compassionate and skilled Senior Care Professional to join our team at Commonwealth Senior Living. As a Licensed Practical Nurse, you will play a vital role in providing high-quality care to our residents, working under the direction of the Resident Care Director. Your main objective will be to administer and document...

  • Senior Nursing Director

    4 weeks ago

    Boston, Massachusetts, United States Mass General Brigham Full time

    Job Title: Senior Nursing DirectorMass General Brigham is seeking a highly skilled and experienced Senior Nursing Director to lead our nursing team in Boston, Massachusetts.About the Role:The Senior Nursing Director will be responsible for overseeing the 33 bay Center for Perioperative Care Unit (CPC), 92 bay Post Anesthesia Care Units (PACUs), and the 10...

  • Revenue Management Director

    2 weeks ago

    Boston, Massachusetts, United States Five Star Senior Living Full time

    Job Title: Director of Revenue ManagementFive Star Senior Living is seeking a highly skilled Director of Revenue Management to join our team. As a key member of our leadership team, you will be responsible for developing and implementing a comprehensive revenue management program that drives rate governance, efficiency, and revenue optimization across our...

  • Associate Director/Director Medicinal Chemistry

    3 days ago

    Boston, United States Kestrel Therapeutics Full time

    Associate Director/Director, Medicinal ChemistryAt Kestrel, our mission is to invent cutting-edge technologies and develop novel small molecule agents targeting critical cancer pathways. Our focus is on mutant RAS, cancer’s most frequently mutated oncogenic target. We are committed to rigorously applying innovative science to discover new medicines for...

  • Associate Director/Director Medicinal Chemistry

    4 weeks ago

    Boston, United States Kestrel Therapeutics Full time

    Associate Director/Director, Medicinal ChemistryAt Kestrel, our mission is to invent cutting-edge technologies and develop novel small molecule agents targeting critical cancer pathways. Our focus is on mutant RAS, cancer’s most frequently mutated oncogenic target. We are committed to rigorously applying innovative science to discover new medicines for...

  • Associate Director/Director Medicinal Chemistry

    3 weeks ago

    Boston, United States Kestrel Therapeutics Full time

    Associate Director/Director, Medicinal ChemistryAt Kestrel, our mission is to invent cutting-edge technologies and develop novel small molecule agents targeting critical cancer pathways. Our focus is on mutant RAS, cancer’s most frequently mutated oncogenic target. We are committed to rigorously applying innovative science to discover new medicines for...