Principal Scientist, Large Molecule DMPK
Scorpion Therapeutics, Rancho Santa Fe, California, United States
Role Summary
Lead the application of absorption, distribution, metabolism, excretion (ADME) science to advance Neurocrine’s large molecule portfolio. Serve as a technical leader within the DMPK department, participating in all stages of ADME assessment from initial compound screening through IND and NDA regulatory submissions. Represent DMPK on Research and Development teams and collaborate with internal and external colleagues to disseminate ADME information timely and accurately. Responsibilities
Acts as a DMPK representative on project teams providing scientific and strategic input Design, execute, and manage the conduct, interpretation, and reporting of in vitro drug metabolism data, in vivo PK studies, and PK-PD studies Prepare data summaries and present results to peers, colleagues, project teams and leadership Oversee outsourcing partners of DMPK studies, ensuring partners adhere to contractual standards, within budget Provides expert level contribution in the preparation and review of regulatory submissions Integrate in vitro ADME, in vivo PK, and PK/PD endpoints with discovery biology data to define structure activity- and structure-property-relationships to guide optimization strategies Develop data visualization strategies to ensure consistent data interpretation across project teams to drive portfolio decisions Aid in ADME knowledge management Effectively partner to apply innovative mechanistic modeling approaches to translate and predict human PK, inform clinical plans, and support compound registration Will provide mentorship to and frequently supervise the day-to-day work of less experienced team members Qualifications
BS/BA in biology, chemistry, or related science field and 12+ years of hands-on experience as DMPK project team representative with an emphasis on large molecule modalities MS/MA in biology, chemistry, or related science field and 10+ years of similar experience PhD or equivalent and 4+ years of relevant experience; may include postdoc experience Demonstrated results/experience in working with interdisciplinary teams Working knowledge of the principles of ADME and pharmacokinetics Solid understanding of organic/medicinal chemistry Strong communication skills (written and verbal) Ability to lead, guide and influence teams in decision making Proficient in analyzing and visualizing multi-dimensional scientific data Excellent communication, problem-solving, analytical thinking skills Excellent project management skills Ability to mentor and direct the day-to-day work of less experienced team members Expertise acting as a large molecule DMPK representative on discovery teams Ability to work as part of and lead multiple teams Evaluate and apply innovative PK and PK/PD approaches to predict human PK, using modeling to help generate hypotheses, design studies, inform clinical plans, and support registration Experience with mathematical modeling workflows using software such as R, Matlab, Python, SimCyp, WinNonLin, SimulationsPlus, Monolix, etc. Proficient in scripting/programming in Python, C/C++, or R Build a strong external network and stay up to date with emerging literature and science in the area Sees broader picture, impact on multiple programs, teams and/or departments Ability to meet multiple deadlines across a variety of projects/programs with a high degree of accuracy and efficiency Education
BS/BA in biology, chemistry, or related science field MS/MA in biology, chemistry, or related science field PhD or equivalent degree
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Lead the application of absorption, distribution, metabolism, excretion (ADME) science to advance Neurocrine’s large molecule portfolio. Serve as a technical leader within the DMPK department, participating in all stages of ADME assessment from initial compound screening through IND and NDA regulatory submissions. Represent DMPK on Research and Development teams and collaborate with internal and external colleagues to disseminate ADME information timely and accurately. Responsibilities
Acts as a DMPK representative on project teams providing scientific and strategic input Design, execute, and manage the conduct, interpretation, and reporting of in vitro drug metabolism data, in vivo PK studies, and PK-PD studies Prepare data summaries and present results to peers, colleagues, project teams and leadership Oversee outsourcing partners of DMPK studies, ensuring partners adhere to contractual standards, within budget Provides expert level contribution in the preparation and review of regulatory submissions Integrate in vitro ADME, in vivo PK, and PK/PD endpoints with discovery biology data to define structure activity- and structure-property-relationships to guide optimization strategies Develop data visualization strategies to ensure consistent data interpretation across project teams to drive portfolio decisions Aid in ADME knowledge management Effectively partner to apply innovative mechanistic modeling approaches to translate and predict human PK, inform clinical plans, and support compound registration Will provide mentorship to and frequently supervise the day-to-day work of less experienced team members Qualifications
BS/BA in biology, chemistry, or related science field and 12+ years of hands-on experience as DMPK project team representative with an emphasis on large molecule modalities MS/MA in biology, chemistry, or related science field and 10+ years of similar experience PhD or equivalent and 4+ years of relevant experience; may include postdoc experience Demonstrated results/experience in working with interdisciplinary teams Working knowledge of the principles of ADME and pharmacokinetics Solid understanding of organic/medicinal chemistry Strong communication skills (written and verbal) Ability to lead, guide and influence teams in decision making Proficient in analyzing and visualizing multi-dimensional scientific data Excellent communication, problem-solving, analytical thinking skills Excellent project management skills Ability to mentor and direct the day-to-day work of less experienced team members Expertise acting as a large molecule DMPK representative on discovery teams Ability to work as part of and lead multiple teams Evaluate and apply innovative PK and PK/PD approaches to predict human PK, using modeling to help generate hypotheses, design studies, inform clinical plans, and support registration Experience with mathematical modeling workflows using software such as R, Matlab, Python, SimCyp, WinNonLin, SimulationsPlus, Monolix, etc. Proficient in scripting/programming in Python, C/C++, or R Build a strong external network and stay up to date with emerging literature and science in the area Sees broader picture, impact on multiple programs, teams and/or departments Ability to meet multiple deadlines across a variety of projects/programs with a high degree of accuracy and efficiency Education
BS/BA in biology, chemistry, or related science field MS/MA in biology, chemistry, or related science field PhD or equivalent degree
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