29 days old

Associate Director, Clinical Scientist

Tesaro, Inc
Waltham, MA 02452
  • Job Code
    19000041

Associate Director, Clinical Scientist

Do you have the passion to join a young global biopharmaceutical whose sole mission is to improve the lives of patients bravely facing cancer? Does it excite you to be a part of a rapidly expanding company with multiple marketed products and a diverse and robust pipeline? If yes, you may be a great fit for our community of dedicated and innovative associates.

Your impact at TESARO:

The Associate Director, Clinical Scientist will provide scientific support for all Medical Development activities involving the conduct of clinical studies, including: study feasibility, data management requirements, preparation of meeting materials and internal/external presentations, communication plans (e.g., administrative letters, protocol amendments, protocol deviations), safety and medical monitoring, preparation of status update reports and study close-out activities, writing manuscripts (paper, abstracts, posters, etc.), and reviewing and summarizing relevant literature. S/he will support the Medical Lead with medical monitoring reports, safety reviews, site interactions, and reviewing study tables, listings and figures. Responsible for analytical support of clinical trial data (safety and efficacy), including gathering, analyzing, reviewing, interpreting, and providing preliminary assessments and recommendations to Medical Lead. Analyze and synthesize information to assess issues relating to protocol conduct and/or individual subject safety. Assist in communicating a clear overview of trial results. S/he will clearly communicate concepts and information, both in writing and via formal presentations, to scientific and medical experts, both internal and external to the company. S/he will have a substantial role in the development of clinical documents, the review of scientific and clinical data and the communication of data to the scientific and medical communities. The role will report to a Medical Director and will collaborate with Clinical Pharmacology, Clinical Research and other functions within TESARO.


Job Responsibilities:


Study Data Review and Analysis:

  • Prepare Medical Data Review Plan and Medical Monitoring Plan

  • Perform ongoing review and analysis of study data per Medical Data Review Plan

  • Organize, present and facilitate regular cross-functional data review meetings

  • Provide support for publication of data (manuscripts, posters, etc.)

    Clinical Oversight of Ongoing Trials:

  • Contribute to the clinical oversight and medical review of clinical trial data in collaboration with the Medical Monitor during the conduct of the study

  • Collaborate with internal stakeholders (clinical operations, data management, statistics, safety, commercial, and regulatory affairs) to ensure translation of the clinical protocol into operational deliverables

    Medical Writing:

  • Clinical Study protocols and protocol synopses,

  • Clinical Study Reports, IBs, ICFs, training documents

  • Responses to clinical questions from Agencies and/or IRBs/ECs

  • Support preparation of scientific material for conference presentations or publications

  • Contribute to the authoring and revision of regulatory submissions


    Review of Scientific Literature:

  • Perform literature searches and critically review and summarize the relevant scientific, drug development and medical literature to support document development, such as the investigator brochure, protocol design, clinical study report, etc.

  • Provide scientific/medical supportive materials to in-house staff and external consultants

  • Identify and review literature that addresses specific topics of interest relevant to TESARO drug candidates

    Requirements:

  • PhD, MD, MSc/MPH, PharmD, with 10 years of experience in a pharmaceutical company environment. Doctoral level degree preferred.

  • Hematology/oncology disease experience preferred

  • Excellent management, communication (both verbal and written) and organizational skills required with demonstrated success in leading projects and interacting with cross-functional teams

  • Strong attention to detail

  • Passionate, committed and a strong team player

  • Ability to work independently and reliably deliver objectives of high quality in a timely manner

  • Ability to think creatively, function independently, deliver on timelines, have strategic insights and have a detailed knowledge of the activities and procedures involved in clinical drug development.

    TESARO is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.







  • Posted: 2019-04-23 Expires: 2019-05-22
    Sponsored by:
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    Sponsored by:
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    Associate Director, Clinical Scientist

    Tesaro, Inc
    Waltham, MA 02452

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