Associate Director/Director, Head of Pharmacology, DMPK

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Who We Are
Generate Biomedicines, Inc. is a Flagship backed, privately-held biotechnology company on a mission to reimagine the drug discovery process to one of dynamic, data-driven generation. We pursue this audacious vision because we believe in the unique and revolutionary power of generative biology to radically transform the lives of billions, with an outsized opportunity for patients in need. Generate will be successful by constantly turning innovative ideas into methods, technologies, and products that solve some of the most difficult challenges with developing medicines. We are seeking collaborative, relentless problem solvers that share our passion for impact to join us!

Generate was founded by Flagship Pioneering. Flagship Pioneering conceives, creates, resources, and develops first-in-category life sciences companies to transform human health and sustainability. Since its launch in 2000, the firm has applied a unique hypothesis-driven innovation process to originate and foster more than 100 scientific ventures, resulting in over $30 billion in aggregate value. The current Flagship ecosystem comprises 37 transformative companies, including: Moderna Therapeutics (NASDAQ: MRNA), Rubius Therapeutics (NASDAQ: RUBY), Indigo Agriculture, and Sana Biotechnology.

Position Summary

We are seeking a experienced DMPK Scientist to build a preclinical pharmacology team at Generate Biomedicines and to help us usher our first biotherapeutic drug candidates into human studies. The successful candidate will have deep expertise in PKPD and DMPK modeling and the desire to integrate best practices in this field with cutting edge computational and machine learning techniques to drive the development of the next generation of preclinical pharmacology research. This individual will be responsible for helping to lead the preclinical assessment of Generate’s first wave of therapeutics through collaboration with internal stakeholders across the organization, including Machine Learning and Computational Biologists, Protein and Preclinical Scientists, and Clinical Development, as well as external collaborators and CROs. This is an exciting opportunity for a scientist who wants to play an integral role in the development of a novel platform capable of transforming the drug development industry by bringing cutting edge data science and machine learning tools to bear on DMPK and PK/PD research.

Key Responsibilities

  • Design and execute preclinical studies to understand the pharmacokinetics (PK) and absorption, metabolism, distribution, and excretion (ADME) of protein therapeutics including antibodies, peptides and modular proteins
  • Develop quantitative tools to translate PK/PD relationship from preclinical to clinical using modeling and simulation
  • Serve as subject matter expert on DMPK and PK/PD on project teams
  • Lead the evaluation, selection and oversight of CROs in the execution of relevant in vivo studies
  • Responsible for the analysis, interpretation, and reporting of preclinical DMPK data generated both internally and with external vendors
  • Partner with and support Machine Learning, Preclinical Research, Clinical, Regulatory, Protein Sciences and other departments
  • Have deep expertise in regulatory guidance relating to DMPK of protein therapies and lead authorship of appropriate sections of regulatory documents including INDs and CTAs
  • Build pharmacology team of scientists with a desire to integrate cutting edge machine learning and data analysis tools with best practices in the industry to drive robust pipeline of protein therapeutics in to clinic.

Qualifications

  • PhD in Pharmacokinetics, Pharmacology, Pharmaceutics or other relevant field with 8+ years of experience in the biopharmaceutical industry, with an established record of success in drugs development
  • Strong knowledge of drug metabolism, ADME concepts, pharmacokinetics, pharmacodynamic and bioanalytical principles is required
  • Experience with biologics including monoclonal antibodies, bi-specifics, novel antibody platforms, peptides and modular proteins is very desirable
  • Experience applying concepts in machine learning to DMPK and PK/PD modeling is highly advantageous
 
Flagship Pioneering and our ecosystem companies are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.
 
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