NewtonRecruiter Since 2001
the smart solution for Newton jobs

Associate Director, Clinical Pharmacology

Company: Karyopharm Therapeutics
Location: Newton
Posted on: June 10, 2021

Job Description:

Responsibilities

SUMMARY:

Karyopharm is seeking an Associate Director/Director, Clinical Pharmacology and Pharmacometrics to lead oncology programs in early and late stages of clinical development - contributing to the design, planning, execution and interpretation of Clinical and Clinical Pharmacology studies. He/she should be familiar with current practices in most of the following areas: clinical pharmacology, pharmacometrics, DMPK, and bioanalytical assay. He/she should have a strong knowledge of best regulatory practices, and a demonstrated ability to make data-driven decisions based on pre-clinical and clinical information.

RESPONSIBILITIES:

  • Lead the design, planning, execution, and interpretation of Clinical and Clinical Pharmacology studies
  • Perform pharmacokinetic and pharmacodynamic data analysis
  • Lead the design and development of Clinical Pharmacology submission documents for regulatory filings
  • Represent Clinical Pharmacology in regulatory interactions, which may include addressing inquiries from and participating in meetings with regulatory authorities
  • Collaborate cross-functionally with other departments, such as Biostats, Clinical, Translational Science, PV and Regulatory

Qualifications

jjjjjj QUALIFICATIONS:

  • PharmD or PhD with a minimum of 3 years of bio/pharmaceutical experience in Clinical Pharmacology and/or Pharmacometrics
  • Strong communication and project management skills will be essential to thrive within cross-functional teams
  • An established track record of scientific project management, and an ability to lead multiple initiatives in a dynamic and fast paced environment
  • Hands on experiences drafting clinical pharmacology documents (protocols, PK report, CSRs, etc.)
  • Hands-on experience designing, conducting and interpreting clinical pharmacology studies
  • Hands-on experience on population PK/PD models, exposure-response analysis, and other standard forms of modeling and simulation, is highly desirable
  • Experience in preparing regulatory submissions such as INDs or NDAs and direct drug development experience within oncology is desired but not required

Overview

Karyopharm Therapeutics Inc. (NASDAQ: KPTI) is a commercial-stage pharmaceutical company pioneering novel cancer therapies and dedicated to the discovery, development, and commercialization of first-in-class drugs directed against nuclear export for the treatment of cancer and other diseases. Karyopharm's Selective Inhibitor of Nuclear Export (SINE) compounds function by binding with and inhibiting the nuclear export protein XPO1 (or CRM1). Karyopharm's lead compound, XPOVIO (selinexor), is approved in the U.S. in multiple hematologic malignancy indications, including in combination with Velcade (bortezomib) and dexamethasone for the treatment of adult patients with multiple myeloma after at least one prior therapy, in combination with dexamethasone for the treatment of adult patients with heavily pretreated multiple myeloma and as a monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma. NEXPOVIO (selinexor) has also been granted conditional marketing authorization in combination with dexamethasone for adult patients with heavily pretreated multiple myeloma by the European Commission. In addition to single-agent and combination activity against a variety of human cancers, SINE compounds have also shown biological activity in models of neurodegeneration, inflammation, autoimmune disease, certain viruses and wound-healing. Karyopharm has several investigational programs in clinical or preclinical development. For more information, please visit www.karyopharm.com.

Karyopharm Therapeutics Inc. (the "Company") is an equal opportunity employer. All qualified applicants will be considered without regard to age, race, color, sex, religion/creed, national origin, marital status, ancestry, citizenship, military, reservist or veteran status, pregnancy, sexual orientation or preference, gender identity, gender expression, physical or mental disability, genetic predisposition or carrier status, or any other category protected under applicable federal, state or local law. Consistent with its obligations under applicable law, the Company will make reasonable accommodations for qualified individuals with disabilities. If you require an accommodation in the application process, please contact a member of the Company's Human Resources department.

Keywords: Karyopharm Therapeutics, Newton , Associate Director, Clinical Pharmacology, Other , Newton, Massachusetts

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Log In or Create An Account

Get the latest Massachusetts jobs by following @recnetMA on Twitter!

Newton RSS job feeds