Location
New Jersey | United States
Job 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.
Summary
Oversees one or more trials of medium to high complexity in design and geographic scope. Such trials could be pivotal for submission; 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.
Responsibilities: - 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 2.7.3 of eCTD.
- Study Strat egy: Clinical Study Leader (CSL) or Major Scientific/Medical Contributor; For large or complex Phase 2 Studies: 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.
- Study Planning and Execution : As CSL for Phase 2 Studies: 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; establishes and implement contingency plans for shortfalls, Consults recruits members for DSMB and/or adjudication committee setup; Interacts with KOLs and PIs to plan study and monitor completion.
- Study Outputs : For Phase 2 Studies: 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.
- External Collaboration: Develops and leads external advisory panels to advise on Phase 2 study strategy, design, and conduct; Interacts with KOLs for indication specific advice; Leads broad collaboration with KOLs or major institution, e.g., NCI.
- Scientific, Program Related: Integrated Study Team (IST) Representative: Creates early development plan and contributes to overall development Strategy; Develops program biomarker strategy; Achieves endorsement for plan by function and team; Interprets and react accordingly to new preclinical/clinical e.g., Go/No Go decisions, reprioritization, etc.); Operational Project Team (OPT) leader; Responsible before the IST for the creation and execution of development strategy for a program.
- People Management: Direct reports management - Hire and retain high quality (Team) members; Ensure team members have updated development plans and provide them with necessary means to achieve their personal development goals; Review annual goals with team members; Prepare annual performance reviews for direct reports and provide them with feedback.
- Additional Non-Study Related Activities: 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; Contributor to portfolio decisions.
Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education Qualifications: (from an accredited college or university)
- MD or equivalent required
- Postgraduate training in TA or related specialty preferred Experience Qualifications
- 4 or More Years relevant clinical experience required.
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. 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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