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Senior Scientist, DMPK

Company: Nomis Solutions
Location: Cambridge
Posted on: February 18, 2021

Job Description:

DMPK Scientist will have strong DMPK and PKPD modelling experience providing project team support to enable first in human gene therapy studies. Summary of Key Responsibilities

  • Serve as DMPK subject matter expert (SME) on research and development project teams
  • Design and execute preclinical studies to understand the pharmacokinetics (PK) and absorption, metabolism, distribution, and excretion (ADME) of gene therapy products including CAR-T and delivery via lipid nanoparticles (LNP)
  • Build and develop quantitative tools to translate PK/PD relationship from preclinical to clinical using modeling and simulation
  • Lead human dose prediction effort by providing input into the design of preclinical studies to investigate exposure and pharmacodynamic (PD) responses
  • Responsible for the analysis, interpretation, integration, and reporting of preclinical DMPK data generated both internally and with external vendors
  • Author high quality Regulatory documents including INDs, CTAs and NDA filings. Partner with and support Toxicology, Research, Clinical, Regulatory, Project Management and other departments
  • Deep understanding of regulatory guidance relating to DMPK and gene therapies, including LNP delivery
  • Participate in the selection and management of CROs for the conduct of in vivo ADME studies
  • Experience with in vivo ADME studies up to and including human mass balance studies Qualifications
    • PhD in Pharmacokinetics, Pharmacology, Pharmaceutics or other relevant field with 10+ years of experience in the biopharmaceutical industry, with a proven record of drug development experience
    • Strong knowledge of drug metabolism, ADME concepts, pharmacokinetics, pharmacodynamic and bioanalytical principles is required.
    • Experience with gene therapy products, CAR-T, and lipid nanoparticle delivery is highly desired
    • Proficient in using WinNonlin or other pharmacokinetic software U.S. Equal Opportunity Employment Information (Completion is voluntary) Individuals seeking employment at Beam Therapeutics are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation. You are being given the opportunity to provide the following information in order to help us comply with federal and state Equal Employment Opportunity/Affirmative Action record keeping, reporting, and other legal requirements. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file. Gender Please select Are you Hispanic/Latino? Please select Race & Ethnicity Definitions If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows: A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability. A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service. An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense. An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985. Veteran Status Please select Form CC-305 OMB Control Number 1250-0005 Expires 05/31/2023 Voluntary Self-Identification of DisabilityWhy are you being asked to complete this form? We are a federal contractor or subcontractor required by law to provide equal employment opportunity to qualified people with disabilities. We are also required to measure our progress toward having at least 7% of our workforce be individuals with disabilities. To do this, we must ask applicants and employees if they have a disability or have ever had a disability. Because a person may become disabled at any time, we ask all of our employees to update their information at least every five years. Identifying yourself as an individual with a disability is voluntary, and we hope that you will choose to do so. Your answer will be maintained confidentially and not be seen by selecting officials or anyone else involved in making personnel decisions. Completing the form will not negatively impact you in any way, regardless of whether you have self-identified in the past. For more information about this form or the equal employment obligations of federal contractors under Section 503 of the Rehabilitation Act, visit the U.S. Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp . How do you know if you have a disability? You are considered to have a disability if you have a physical or mental impairment or medical condition that substantially limits a major life activity, or if you have a history or record of such an impairment or medical condition. Disabilities include, but are not limited to:
      • Autism
      • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, or HIV/AIDS
      • Blind or low vision
      • Cancer
      • Cardiovascular or heart disease
      • Celiac disease
      • Cerebral palsy
      • Deaf or hard of hearing
      • Depression or anxiety
      • Diabetes
      • Epilepsy
      • Gastrointestinal disorders, for example, Crohn's Disease, or irritable bowel syndrome
      • Intellectual disability
      • Missing limbs or partially missing limbs
      • Nervous system condition for example, migraine headaches, Parkinson's disease, or Multiple sclerosis (MS)
      • Psychiatric condition, for example, bipolar disorder, schizophrenia, PTSD, or major depression Disability Status Please select 1 Section 503 of the Rehabilitation Act of 1973, as amended. For more information about this form or the equal employment obligations of Federal contractors, visit the U.S. Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp . PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.

Keywords: Nomis Solutions, Cambridge , Senior Scientist, DMPK, Other , Cambridge, Massachusetts

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