Karyopharm Therapeutics Inc.

  • Medical Director, Clinical Development

    Job Locations US-MA-Newton
    Job ID
    2018-1194
    # of Openings
    1
    Category
    Research and Development
    Type
    Regular Full-Time
  • Overview

    Karyopharm Therapeutics is a clinical-stage pharmaceutical company focused on the discovery and development of novel first in-class drugs directed against nuclear transport targets for the treatment of cancer and other major diseases.

    Responsibilities

    The Medical Director will serve as the primary medical lead for Karyopharm clinical trials with cross-functional study teams on clinical trial strategy, design and execution. Along with this, the Medical Director will serve as the primary Medical Monitor responsible for monitoring the safety of enrolled subjects on assigned trials. This individual will work on multiple trials in Phases 1 through 3.

     

    • Participates in the 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 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).
    • Acts as liaison between Clinical Development and other internal groups at Karyopharm (e.g., Regulatory Affairs, Clinical Operations, Clinical Data Management) for assigned studies.
    • Represents Karyopharm to outside medical personal in the development of clinical protocols and study conduct.

    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

    Prefered Qualifications

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

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