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    Scientific Director, Medical - New Jersey, United States - Daiichi Sankyo, Inc.

    Daiichi Sankyo, Inc.
    Daiichi Sankyo, Inc. New Jersey, United States

    4 weeks ago

    Daiichi Sankyo, Inc. background
    Description
    Join a Legacy of Innovation 110 Years and Counting

    Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology.

    With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people.

    Under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.

    Oversees one or more trials of medium to high complexity in design and geographic scope.

    Prepares clinical section of regulatory documents; Oversees management and performance of CRO; Participates in creation of developmental and regulatory strategy; Drafts protocol profiles and sections of key submission documents; Point of contact for interactions with regulatory-agency clinical reviewing divisions on clinical matters; Represents Clinical Development in Project Teams, possibly as Global Clinical Lead.

    Medical Monitoring Planning (MD Only): For large Phase 2 or Phase 3 studies: Reviews, edits, approves and updates medical monitoring plan, Develops SAE flow plan for AESI in conjunction w/ CSPV, Defines medical monitoring oversight component of study QOP, Sets up DSMB and/or adjudication committee; reviews and edits DSMB/ Adjudication charters, Develops medical content for protocol profile, protocol and amendments for small, uncomplicated clinical studies; Directs CRO medical monitor activities for Phase 2 studies; Regional sponsor medical monitor for Phase 3 study.

    Medical Surveillance (MD only): For large Phase 2 or Phase 3 studies: Collaborates with CSPV to ensure monitoring / reporting of AEs/SAEs, Reviews safety reports/data during study conduct, Provides and documents oversight of medical monitoring activities, Reviews data before DBL from medical perspective, assist BDO in creation of TFG, Reviews, oversees creation of patient narratives, Provides medical direction to MW for the CSR; Leads indication specific surveillance and safety summaries, such as Section 2.Clinical Study Leader (CSL) or Major Scientific/Medical Contributor; Provides the strategic direction to BDO for EDC, edit checks, data quality listings, SAP, DM plan, Reviews patient population and protocol compliance for consistency with study strategy, develops biomarker strategy in collaboration with TMCP, collaborates with external KOLs to refine study plans; Prepares and participate in regulatory agency meetings, if applicable.

    Provides input on major milestones of trial, clinical trial plan and contingency planning, Analyzes, updates management on potential risks to study deliverables, provides input on ICF creation, oversees recruitment, retention; Drafts responses to IRBs and HA, Collaborates with TMCP to ensure appropriate biomarker, PK / PD measurements, Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment with delivery lead e.g.

    review TLG before DBL, and quality check of data, Works with BDO to ensure SAP updates; Responsible for valid clinical interpretation of study results as Clinical Study Leader, medical monitor or regional clinical/Translational Medicine and Clinical Pharmacology representative.


    Scientific, Program Related:
    Interprets and react accordingly to new preclinical/clinical e.g.

    , Operational Project Team (OPT) leader; People Management:

    Direct reports management - Hire and retain high quality (Team) members; Prepare annual performance reviews for direct reports and provide them with feedback.

    Initiates contact w/KOL and prepare material for KOL interactions on a program-based need; Peripheral involvement in Business Development activities for late-stage compounds Involvement with in-licensing and acquisitions on individual due diligence activities; Postgraduate training in TA or related specialty preferred Experience Qualifications
    ~Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
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