Morphic Therapeutic Inc Hiring for Principal Scientist / Associate Director, DMPK Job at Waltham, MA Full Time

About Morphic Therapeutic

Morphic Therapeutic is a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, including autoimmune, cardiovascular and metabolic diseases, fibrosis and cancer. In collaboration with Janssen and Schrödinger, Morphic is advancing its pipeline and discovery activities using its proprietary MInT technology platform which leverages the Company’s unique understanding of integrin structure and biology. For more information, visit www.morphictx.com.Morphic is advancing both partnered and fully-owned oral integrin therapeutic candidates with the initial clinical trials beginning in 2020. Our immediate focus is on the areas where the clinical activity of antibody inhibitors of integrins is precedented, thus enabling a rapid path to clinical proof-of-concept. Morphic Therapeutic is located in the AstraZeneca BioHub in Waltham, MA. We are seeking a highly talented and motivated individual to join our culture of teamwork, craftsmanship, tenacity, compassion, integrity, and beauty.

Essential Job Functions:Responsibilities include, but are not limited to:

• Serve as the DMPK project representative to ensure effective execution of studies and active integration of ADME, PK, and PK/PD information into lead optimization efforts.
  • Identify critical ADME/PK needs, prioritize function activities, and propose strategies.
  • Design and oversee DMPK studies, review and summarize results, integrate ADME, PK, and PK/PD information to guide multi-disciplinary team efforts in lead optimization and to facilitate selection of development candidates. Implement strategies to risk potential DMPK challenges in LO.
  • Deliver and communicate results to project teams, provide intellectual input, and contribute to decision making.
• Manage interactions with external CROs to ensure high quality and timely execution of DMPK studies; collaborate with other functions to define PK-PD relationships in animal models.
  • Identify and qualify external vendors for ADME, PK, and BA support of research programs.
  • Review experimental procedures, data acquisition andanalysis.
  • Maintain complete and timely data archiving.
  • Coordinate operational logistics among in-house functions and external vendors.
• Work with development teams to support human ADME and DDI studies; serve as a liaison with bioanalytical CRO groups to ensure method development / validation and sample analysis timelines.
  • Participate in CRO selection (e.g. study quotes and capability assessment).
  • Participate in design and review protocol outlines.
  • Ensure timely preparation of contracts; review and process invoices for approval.
  • Deliver non-clinical DMPK packages and study reports within regulatory guidelines and author IND sections of regulatory filings

  Qualifications:

  Required

• PhD in Pharmacokinetics, Pharmaceutical Sciences, Pharmacology, or related disciplines with 8 – 12 years of extensive training and industry experience in Pharmacokinetics, Drug Disposition (metabolism and transport), PK/PD Modeling and Simulation, and Bioanalysis in support of discovery and early development programs.
• In-depth understanding and strategic application of in vitro and in vivo ADME assays, methods and models. Ability to gather relevant information to facilitate human PK and dose projection.
• Direct hands-on experience and strong trouble shooting skills in both in vitro and vivo DMPK studies, including PK and PK/PD analysis, quantitative and qualitative LC-MS analysis, in vitro and in vivo biotransformation, and human PK and drug interaction predictions.
• Expertise in managing CROs and sound knowledge of regulatory guidelines on bioanalysis, GLP practice, and DDIs
• Proficiency in Phoenix WinNonlin (classic WNL and PHX Model).
• Comfort with fast-paced biopharma environment.
• Strong analytical, organizational and communication skills.

Desired

• Ability to develop user-specified mathematical models with Phoenix WinNonlin (classic WNL and PHX Model). Familiarity with Gastroplus, R and NONMEM

Morphic Therapeutic is an equal opportunity employer committed to providing an environment that maximizes our employees’ development and achievement goals. We strive to treat each employee as an individual, as we seek to foster a spirit of teamwork to help change patients’ lives. In addition to a competitive compensation and benefits package that includes medical, dental and vision coverage, a 401K and a generous vacation and holiday schedule.