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Full-Time

Director – Dmpk

Confirmed live in the last 24 hours

Flagship Pioneering

Flagship Pioneering

501-1,000 employees

Biotechnology firm creating health and sustainability solutions

Healthcare
Biotechnology

Senior

Cambridge, MA, USA

Category
Physicians & Surgeons
Medical, Clinical & Veterinary
Required Skills
Communications
Requirements
  • Ph.D. in pharmaceutical science, biochemistry, or a related field with 8+ years of relevant experience, OR MS/BS with 10+ years of relevant experience.
  • Expert knowledge of commonly used software for PK/PD, PBPK, PBPK-PD, & QSP modeling required.
  • Minimum 8+ years of experience, with 6+ yrs. in industry, leading and representing the DMPK function on project teams, especially in discovery and early development.
  • Extensive knowledge of biologics drug metabolism, pharmacokinetics (PK), and relevant analytical techniques.
  • Strong understanding of the analytical methods in biologics, drug discovery workflow; knowledge of biologics along with novel modalities.
  • Hands-on experience conducting, troubleshooting, and summarizing in vitro and in vivo ADME/DMPK studies.
  • Familiarity with regulatory guidelines related to DMPK in drug development is desirable.
  • Demonstrated DMPK expertise through high-quality peer-reviewed publications is a plus.
  • Experience in outsourcing and external oversight of nonclinical DMPK/ADME studies is desirable.
  • Expert in common software for PBPK, PBPK-PD, & QSP modeling required.
  • Leadership experience in an industry setting growing and developing talent and building a team.
Responsibilities
  • Lead the DMPK, Pharmacology and regulated bioanalysis activities.
  • Provide Pharmacology, PK/PD, and DMPK expertise at all stages of discovery and nonclinical development for all programs including biologics.
  • Conduct PK and PK/PD, PBPK modeling, and offer predicted human PK, efficacious dose projections, and drug-drug interaction (DDI) or similar risk assessments as needed.
  • Strong knowledge of regulated bioanalytical methods and current guidance. Familiarity with both LC-MS/MS and ligand binding assay (LBA) method development is a plus.
  • Drive assessment of correlation between exposure & efficacy as well as exposure & toxicity. Provide lead efforts to the DMPK strategy and drive execution to advance projects from early discovery through preclinical development.
  • Balance the internal infrastructure and capabilities vs. outsourcing; maintain an effective network of outside partners, collaborators and service organizations. Including but not limited to overseeing execution of studies at CRO labs along with evaluation of protocols, results and related reports.
  • Provide SME support for collaborations on large animal studies along with execution of CRO selection and supervision for toxicology studies as well as the design of non-GLP and GLP studies including NHP studies.
  • Partner with Nonclinical development to ensure the integration of nonclinical and early clinical findings with planned clinical programs; secure cross functional alignment and transparent discussion of opportunities and risks, with clear plans to further investigate, optimize, and track throughout development.
  • Provide recommendations to senior management of other line functions regarding key program decisions.
  • Provide SME support for regulatory submission (INDs, CTA, NDAs, MAAs) and in health authority (FDA, EMA, PMDA) interactions, and experience in developing strategies around those interfaces in collaboration with the Regulatory function.
  • Provide support to Tech Ops (Manufacturing/CMC) to problem solve real-time issues with drug substance/drug product in stages of nonclinical development.
  • Ensure high quality review of key study documents, including protocols, study reports, regulatory documents, publications, and formal and informal presentations of study data.
  • Represent DMPK during interactions/presentations with Regulatory Agencies as a subject matter expert and thought leader. Develop and maintain relationships with KOLs, researchers, and academics.
  • Leader/coach/mentor of other project representatives in the team.
  • Foster and ensure a culture of transparency of progress against department infrastructural goals and various team goals, by modeling best practice for risk and issue identification, communication, and mitigation/management.

Flagship Pioneering fosters a culture of groundbreaking advancements in biotechnology, emphasizing an ecosystem approach that synergizes human health and sustainability. Their business model not only focuses on creating transformative products but also incubates leading companies like Moderna and Indigo Agriculture, positioning them at the forefront of scientific innovation and industry leadership. This approach offers employees a unique opportunity to be part of a pioneering team that drives real-world impacts across multiple sectors.

Company Stage

N/A

Total Funding

$6.4B

Headquarters

Cambridge, Massachusetts

Founded

2000

Simplify Jobs

Simplify's Take

What believers are saying

  • Flagship's recent $3.6 billion raise will support the creation of 25 new breakthrough companies, offering substantial growth opportunities.
  • The firm's track record of founding over 100 biotechnology companies, including industry leaders like Moderna, highlights its potential for high-impact innovation.
  • Key leadership appointments and promotions, such as Lovisa Afzelius to General Partner, strengthen Flagship's strategic direction and operational capabilities.

What critics are saying

  • The ambitious goal of creating 25 breakthrough companies may stretch resources and focus, potentially impacting the quality of each venture.
  • Heavy reliance on AI and advanced computational techniques could face technological and regulatory hurdles, slowing down progress.

What makes Flagship Pioneering unique

  • Flagship Pioneering's focus on creating and developing breakthrough companies in human health, sustainability, and AI sets it apart from traditional venture firms.
  • Their significant capital pool of $10.9 billion and $14 billion in assets under management provides unparalleled financial backing for innovative ventures.
  • Flagship's unique approach to leveraging generative AI for drug discovery and development accelerates the creation of transformative technologies.