Karyopharm Therapeutics Inc.

  • Medical Director, Clinical Development

    Job Locations US-MA-Newton
    Job ID
    2019-1329
    # of Openings
    1
    Category
    Research and Development
    Type
    Regular Full-Time
  • Responsibilities

    The Medical Director will report to the VP of Clinical Development and serve as the primary medical lead for Karyopharm clinical trials with cross-functional study teams on clinical trial strategy, design, execution and medical monitoring. . This individual will have the opportunity to work on more than one trials in Phases 1 through 3 at a time depending on the stage and scale of the trials. The successful candidate will thrive in an innovative and fast-paced culture and enjoy bringing novel technology forward in addition to be a passionate contributor and a highly-effective internal and external team player. 

     

    • Participates in the strategic planning, study design, development of Study Protocols, Investigator’s Brochures, Clinical Development Plans and other key study documents in conjunction with other line functions and with minimal guidance.
    • Serves as medical lead on cross-functional teams for assigned trials, working with other team members to achieve efficient, high-quality study execution.
    • Participates in the preparation of regulatory documents in support of regulatory submissions, including clinical section of IND’s and CTA’s, IND safety reports and annual reports for assigned trials, responses to regulatory authorities and Ethics Committees/IRBs, and other documents as appropriate.
    • Provides scientific and clinical input to study-related documents and analysis plans including Informed consent forms (ICF), clinical research forms (CRF), statistical analysis plans (SAP), clinical pharmacology analysis plans (CPAP), and clinical study reports (CSR).
    • Develop and maintain strong, collaborative relationship between Clinical Development and other internal groups at Karyopharm (e.g., Regulatory Affairs, Biostatistician, Programing, Medical Writing, Clinical Operations, Clinical Data Management) for assigned studies.
    • Represents Karyopharm to outside medical personal in the development of clinical protocols and study conduct.
    • Identifies and builds relationships with investigators and thought leaders.

    Qualifications

    • MD, DO or equivalent ex-US medical degree (non-MD candidates with doctoral degrees may be considered if they have an appropriate background in a clinical field).
    • Minimum of 5 years clinical research experience in an academic or industrial setting, with experience in analysis of research data and publications; working knowledge of biostatistics and pharmacokinetics; working knowledge of GCP, scientific and clinical research methods and clinical study design, regulatory requirements for clinical studies;
    • Pharmaceutical/Biotech industry experience, including time managing clinical trials and/or clinical development program(s)
    • Excellent oral and written communication skills
    • Ability to work collaboratively in a fast-paced, team-based matrix environment and to function independently as appropriate

    Preferred Qualifications

    • Board certification/eligibility in Oncology is highly desired
    • Global clinical research experience and experience interacting with regulatory authorities

    Overview

    Karyopharm Therapeutics is a clinical-stage pharmaceutical company, based in Newton, MA, USA, focused on the discovery, development and commercialization of novel, first-in-class agents targeting nuclear transport for the treatment of cancer and other major diseases. Karyopharm is the industry leader in oral Selective Inhibitor of Nuclear Export (SINE) technology, developed to address a central mechanism of oncogenesis via the inhibition of exportins specifically XPO1. Selinexor, Karyopharm’s lead candidate, has been administered to patients with hematologic malignancies or solid tumors in clinical trials worldwide. Karyopharm is currently preparing for its first potential U.S. commercial launch in 2019.

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