Senior Scientist I - Drug Metabolism
Full-time
Novo Nordisk Inc.
About the Department Our Research & Development organization brings together the best minds in life science innovation. The teams located in facilities in Lexington, Watertown, Cambridge and Plainsboro reflect the full R&D continuum, from early research through late-stage clinical development. Here, we are building for the future, creating a distinct R&D community based on collaboration, partnerships, and cutting-edge research across multiple modalities and therapeutic areas. We recognize that improving human health starts here and that patients rely on us. Our R&D hub merges biotech speed and agility with large pharmaceutical company quality, resources, and stability, uniting the best of both worlds to develop new medicines for patients. 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. Relationships Reports to the head of the relevant department at Novo Nordisk. Internal relationships include working closely with technical staff & other members of the scientific leadership team; regular collaborations with members of other research departments at Novo Nordisk; & frequent interaction with project managers & other colleagues across global R&D. Individual may direct the work of other staff members. Individual will interact with external research collaborators both academia- & industry-based. Essential Functions
Qualifications
- 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.
Qualifications
- 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
- Preferred experience includes: DMPK or PK/PD modeling project representative
- Proficiency in scientific communication and stakeholder engagement.
Vacancy posted 10 days ago
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