Senior Scientist I - Drug Metabolism

Novo Nordisk•Lexington, MA

About The Position

The Senior Scientist I will design and conduct absorption, distribution, metabolism and excretion (ADME) research on compounds, drug agents and metabolites in pre-clinical and/or clinical development. Uses a physicochemical approach, attempting to compile various data such as absorption and excretion rates and drug agent half-life in order to establish pharmacokinetic profiles of new chemical and/or molecular entities as well as determining the optimum and safe dosage forms for compounds that have been determined to have indications for various disease groups. Develops protocols and/or prepares study documentation and findings to support domestic and international submissions of new drugs. Demonstrates subject matter expertise. Requires in-depth knowledge and experience. Solid knowledge and skills relevant for NN Business cross-functional understanding. Strong knowledge within a specific process and extensive business understanding across SVP area. Uses best practices and knowledge of internal or external business issues to improve products or services. Works independently; receives minimal guidance. Acts as a resource for colleagues with less experience; may direct the work of other staff members. Perceived as expert within one or several key processes across the VP/CVP area. Handling specialist tasks of high complexity critical to the CVP area. Hands-on work involving highly complex activities; lead project (target, biology, or technology-related) involving coordination of multiple experimental activities & groups, recommends/is responsible for ensuring realistic project timelines & deliverables, work closely with project manager ; deep understanding of subject matter & demonstrates creative, independent thinking to identify & address disease/biology-related questions/gaps, potentially across therapeutic areas; represent NN at conferences & global meetings; may propose & lead external collaborations; author internal reports & external publications; recommend, present, & champion new targets or methodologies. May mentor or directly supervise less experienced team members based on business need, skill, and/or interest.

Requirements

BS/BA with 10+ years of relevant experience; or master’s degree with 8+ years of relevant experience; or PhD with 4+ years’ of relevant experience required
Experience in designing and conducting absorption, distribution, metabolism, and excretion (ADME) research in a pre-clinical and/or clinical development setting
Excellent understanding of ADME principals with hands on experience with PK and PK/PD modeling or biotransformation highly desirable
Strong knowledge and experience in pharmacokinetics and drug metabolism

Nice To Haves

DMPK or PK/PD modeling project representative
Proficiency in scientific communication and stakeholder engagement.

Responsibilities

Lead DMPK strategy for discovery programs across multiple therapeutic areas, aligning ADME objectives with project milestones.
Design and interpret in vitro and in vivo ADME studies to inform lead optimization and candidate selection.
Apply fit-for-purpose in silico models, PK/PD, PBPK, exposure–response, to predict human pharmacokinetics/dose and de risk programs.
Integrate DMPK data with medicinal chemistry and pharmacology to guide chemical design and prioritize novel chemical matter with favorable drug like properties.
Propose and oversee internal and external research initiatives, including study design, data analysis, and documentation to meet project goals.
Collaborate with outsourcing managers to identify, qualify and manage CRO partners with specialized ADME capabilities; ensure quality, timelines and cost effectiveness.
Engage and collaborate with global Novo Nordisk ADME experts to harmonize methodologies, share best practices and leverage cross site expertise.
Provide scientific mentorship and technical leadership to DMPK team members and cross functional colleagues.
Communicate DMPK strategy, findings and risk assessments clearly to project teams and senior management; contribute to go/no go decisions.
Represent the company externally as needed (publications, conferences, scientific consortia) to build visibility for DMPK methods and capabilities.
Maintain awareness of emerging DMPK methodologies, regulatory expectations and modeling technologies; implement applicable innovations to improve discovery throughput and predictivity.