Senior Scientist : Group Leader overseeing DDI in vitro ADME lab - United States
Our company is looking for exceptional individual for a senior scientist DDI in vitro ADME group leader position.
Position will require:
- Strong hands-on expertise in experimental in vitro ADME, enzyme kinetics and drug-drug interaction field; proven track record via publications and industry working groups is highly preferred. Candidate should be able to develop and drive DDI in vitro strategies, design mechanistic studies, and interpret results, to solve ADME liabilities with minimum guidance.
- Bringing scientific leadership to our established DDI in vitro ADME team supporting key in vitro assays such as CYP inhibition, CYP induction, reaction phenotype, plasma protein binding, and mechanistic in vivo studies.
- Playing a key function in characterizing the role of drug metabolizing enzymes in drug disposition and quantitative DDI risk assessment during the discovery-development continuum to enable lead optimization for clinical candidate selection, conduct preclinical development studies, support clinical evaluation and contribute to IND and NDA filings.
- Providing expert advice to other DMPK reps and cross-functional project teams on clinical DDI risk mitigation strategies by utilizing static and dynamic mechanistic DDI prediction models.
- Strong understanding of various DMPK areas such as physicochemical properties, drug metabolizing enzyme & transporter kinetics, mechanistic biotransformation, bioanalytical data troubleshooting is highly preferred.
- Comprehensive understanding of PK and ADME principles, enzyme kinetics, IVIVE and quantitative DDI risk assessment. Strong technical in vitro assay knowledge and up-to-date best industry practices to enhance continuous DDI in vitro assay improvement and strong troubleshooting skills.
- Knowledge of physiologically-based pharmacokinetic modeling and hands on experience with commercial PBPK softwares (SimCYP/Gastroplus).
- Experience with in vitro assays for regulatory filings and understanding of regulatory requirements are necessary.
- Good people management skills, excellent communication skills (both oral and written), detail oriented, and demonstrated experience in leading/mentoring a mid-sized team of junior in vitro ADME lab scientists.
PhD in Organic Chemistry, Pharmacokinetics, Drug Metabolism, Pharmaceutical Sciences, or related field, with 5-7 years of industry experience.
- Through cutting-edge science and medicine, our company discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases.
- Our company is a pioneer in biotechnology and today the Company has the leading portfolio of medicines to treat multiple sclerosis (MS), has introduced the first and only approved treatment for spinal muscular atrophy, and is at the forefront of neurology research for conditions including Alzheimer’s disease, Parkinson’s disease and amyotrophic lateral sclerosis (ALS).
- Our company also manufactures and commercializes biosimilars of advanced biologics.
- Our global organization of nearly 7,000 employees is committed to a single mission: making a meaningful difference in the lives of patients with few or no treatment options.
- Our company was founded in 1978 and today serves patients in nearly 70 countries.
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